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Keywords | PMC10403908 | |||
Introduction | IBD | Maternal mortality statistics in developing nations, particularly in Sub-Saharan Africa (SSA), are alarming. The Maternal Mortality Ratio (MMR) in SSA is estimated to be 545/100,000 live births [Many variables influence maternal health care utilization, including negative socio-cultural issues [The current maternal health statistics show that more work needs to be done to ensure maternity services are available to all women. Access to, and utilization of services must also improve to provide adequate coverage of good quality. However, geographical access (as in distance), to primary-level health facilities (primarily CHPS, maternity homes and health centers) is generally good, as most rural communities are within 5 to 8 (km) of maternal health care [Community initiatives that target the early initiation of antenatal care can be undertaken to prevent difficulties during childbirth [By evaluating the impact of both individual and community level determinants on the utilization of three components of maternal health services (MHS) in a resource-poor setting of northern Ghana, namely, antenatal care (ANC), institutional-based delivery (IBD), and postnatal care (PNC), this paper addresses a critical information gap. This study’s findings will assist programmers in developing effective interventions and strategies to improve maternal health care utilization at the community level in rural Ghana. The findings will also be used to help build evidence-based policies to address the difficulties that Ghanaian women face during pregnancy. | PMC10403908 | |
Methods | PMC10403908 | |||
Study design and population | The effects of the intervention on maternal health choices and outcomes among young married women were evaluated using a randomized controlled assessment approach with cross-sectional pre-post surveys in experimental and control areas. The study population consisted of young married pregnant women. The same pregnant women were later followed up at postpartum using a panel approach. A structured questionnaire was used to collect data on contraceptive awareness and use, coupled with communication on sexual and reproductive health problems, and utilization of prenatal care, institutional delivery and postnatal care services. | PMC10403908 | ||
Study setting | WEST | The study was conducted in the Sissala East and Sissala West Districts of the Upper West Region, Ghana. The districts were initially one district until 2004 when it was split into Sissala East and Sissala West for effective decentralization by the government. They are largely rural settings located in the eastern part of the Upper West Region [ | PMC10403908 | |
Program design | WEST | The project ‘Strengthening the knowledge of women in the community through health education on the importance and utilization of maternal health services (ANC, facility delivery, and PNC)’ was implemented by community-based Maternal Health Agents (COMHAs) and midwives from June 2019-July, 2020. It was to improve the utilization of maternal healthcare services by pregnant women in two subdistricts in Sissala East and another two in the Sissala West Districts. The project reached out to women who have had a pregnancy experience before the present study. The intervention was delivered to women through a multi-pronged intervention which included: sensitizing family members, community mobilization, and capacity building of frontline health functionaries. One component of the intervention had a continuous counseling strategy using pregnancy classes that were held individually and in groups with pregnant women, their husbands, and other family members. Advocacy meetings were also conducted with influential community members such as village chiefs, local government leaders, and religious leaders to foster an enabling environment for improving pregnant women’s access to, and uptake of maternal healthcare services. Another component of the intervention (awareness, promotion, and use of maternal health services through social and behavior change communication), was implemented by community maternal health service promoters to sensitize pregnant mothers and assist mothers to identify risk factors during pregnancy, delivery and postnatal care. Volunteers from the community who were chosen by the community served as the program implementors. The corresponding author (the District Director of Health Services), one physician (a Family Physician), a midwife, and a health information officer led the training. The lead investigator (Corresponding author) and District Health Administration self-funded the activities. | PMC10403908 | |
Sampling method | WEST | There were two and three poor-performing subdistricts (in terms of maternal health indicators) in the Sissala East and Sissala West Districts, respectively. Two subdistricts (one from each district) with similar characteristics were randomly selected out of the five sub-districts. The selected subdistrict (Sakai) of the Sissala East District served as the control arm and all functional health facilities and communities within the selected subdistrict were included in the study. The other subdistrict (Jawia) selected from the Sissala West district served as the intervention arm and again all health facilities and communities were included in the study. Women for the study were selected from communities directly served by the health facilities in the selected subdistricts. Since there were no community-specific population records, the number of women recruited for the study was evenly distributed among the communities. Trained female educators and enumerators were engaged in recruiting and interviewing women. In each community, enumerators worked with the Community Health Officer (CHO) and Community-Based Volunteers to identify and list all eligible women for the study. From this list, a random selection process was used to arrive at the sample size required for the study. | PMC10403908 | |
Inclusion and exclusion criteria | death, abortion | Only postpartum women who had been residents for 12 months of the study and had participated in the intervention from 3 to 12 months in the study area were interviewed. Women who resided in the study subdistricts and had received the intervention throughout the period but might have received ANC, skilled delivery, and PNC services in a different health facility or elsewhere throughout their pregnancy were included in the end-line assessment. Moreover, the end-line evaluation included women who had received the intervention right from the first trimester to the third. Women who voluntarily agreed to participate in the study and signed or thumb-printed written consent were included. However, postpartum women who had not benefited from the intervention during the twelve months were excluded from the end-line survey/assessment. Postpartum mothers whose delivery outcome was either abortion, stillbirth, or death and seriously ill postpartum mothers were exempted from the end-line assessment, this is based on the premise that those mothers might be in emotional distress to answer the questionnaire. | PMC10403908 | |
Study instrument | At baseline, a pretested structured interviewer-administered paper questionnaire, designed in the English language, was used to collect data from participating mothers. At the end line, the same structured questionnaire was used in Open Data Kit and uploaded to mobile phones for data collection; a password-protected cloud-based server was used for data storage. Trained female educators and enumerators conducted interviews with questions on demographic characteristics and various health-related behaviours and utilization of these services: antenatal care, facility-based delivery, and PNC. | PMC10403908 | ||
Study variables | This section presents a comprehensive list of both dependent and independent variables utilized in the study, along with their corresponding levels of measurement and variable types. The dependent variable, “Health education intervention”, was a nominal categorical variable with two distinct categories, “Exposed” and “Non-exposed”.The independent variables consist of several categories, including age, education status, occupation status, household size, marital status, type of marriage, ethnicity, husband age, husband education status, husband occupation, radio/TV ownership, listen to radio, radio discussion, and influenced by a radio discussion. Age and household size were measured as a ratio variable on a discrete scale, while the rest were nominal categorical variables.The study also measured three variables related to maternal health services utilization: knowledge on maternal health services utilization, attitude on maternal health services utilization, and practice on maternal health services utilization. These variables were ratio variables measured on a discrete scale. | PMC10403908 | ||
Statistical analysis | IBD | Sample characteristics for women visiting ANC and PNC, as well as those who delivered their babies in health care facilities, were examined using descriptive statistics (means and percentages). At the descriptive analysis level; frequencies, percentages, means, maximums, and minimums were calculated. These statistics provided measures and summaries of the sample and enabled a description of the basic features of the data. Pearson’s Chi-square (χ2) test was used to assess the association between the outcome variables (knowledge, attitude, and practice on the three aspects of safe motherhood) and independent variables (age, marital status, ethnicity, educational status, occupation status, radio/TV ownership, listen to radio, radio discussion, and influenced by radio discussion). T-tests were done to determine differences in mean outcomes of the dependent variables (knowledge score and practice) within the control and intervention arms of the study. This indicated any differences in knowledge and practices as a result of the arms of the study. The mean outcomes of the dependent variables were also compared before and after the intervention and also between controls and interventions. A statistical significance level of p < 0.05 was considered. The dichotomous nature of the outcome variables led to the use of binary logit models. The values ‘1’ and ‘0’ were used to denote outcomes such as yes/no for ANC visits of 4 and > 4. For example, the dependent variables ANC, IBD, and PNC each included two groups (four and more than four visits; institution and home delivery; PNC and no PNC). P-value < 0.05 with a 95% confidence level was used as a cutoff point to declare statistical significance and adjusted odds ratios were used to determine the strength of associations. | PMC10403908 | |
Operational definitions | Knowledge of skilled maternal health services was defined such that women who scored above the mean of knowledge assessment questions were categorized as having good knowledge, and if they scored below the mean, they were considered as having poor knowledge [The attitude was measured by using the Likert scale (1 = strongly agree, 2 = agree, 3 = disagree, and 4 = strongly disagree). A positive attitude was scored by women who responded above the mean of the attitude assessment questions and if below the mean they were categorized as having a negative attitude [ | PMC10403908 | ||
Ethical consideration | CHRPE | WEST | The Kwame Nkrumah University of Science and Technology School of Medical Sciences Committee on Human Research Publication and Ethics (CHRPE) approved the study (CHRPE/AP/190/19). Formal administrative permission was obtained from the Upper West Regional Health Directorate and the Sissala East and Sissala West District Health Directorates to carry out the study. The objectives of the study were explicitly explained to the respondents, the right to withdraw from the study at any time was carefully explained to the respondents, and then written informed consent was obtained from the study participants. To ensure confidentiality and anonymity, the coding of respondents was used. | PMC10403908 |
Results | PMC10403908 | |||
Socio-demographic profile of respondents | Overall, 524 women were interviewed at baseline. This comprised 264 pregnant women sampled in the intervention group, and 260 pregnant women sampled in the control group. At the endline, 492 postpartum women were interviewed, which comprised 250 and 242 women from the control and intervention groups. Women surveyed at both baseline and end-line (two-time points) had similar demographic characteristics. At baseline, most of the pregnant women from both the control (81.0%) and intervention (80.8%) got married when they were aged 18–25 years. Similarly, half of the pregnant women from both the control (50.0%) and intervention (50.0%) groups had no formal education at baseline. At postintervention, most of the postpartum women from both the control (83.6%) and intervention (83.1%) had married at age 18–25 years. The majority of the women from both the control (47.2%) and intervention (42.6%) groups had no formal education in post-intervention (Table
Socio-demographic Characteristics of Women at Baseline and End lineEducationStatusOccupationstatus | PMC10403908 | ||
Pre-and post-assessment of women’s knowledge of, and practices related to the utilization of antenatal care, skilled delivery, and postnatal care | The bivariate analysis (Pearson Chi-square test) showed that at baseline, the outcomes were different between the two groups (control and intervention), differed significantly in terms of ANC attendance (p < 0.0001), place of delivery (p = 0.001), and PNC attendance (p < 0.0001).At post-intervention, there were improvements in the intervention group. The outcomes were different between the two groups (control and intervention), and there was a statistically significant difference in terms of ANC attendance (p = 0.001). In the same vein at post-intervention, the two groups (control and intervention), differed significantly in terms of place of delivery (p = 0.003), and PNC attendance (p < 0.0001) (Table
Utilization of antenatal care, skilled delivery, and postnatal care services in control and intervention arms at baseline and postintervention | PMC10403908 | ||
Percentage of women who knew about obstetric danger signs at baseline and end line in the control and intervention arms | The end-line data showed that women who received the health education intervention from Community Maternal Health Agents and midwives about obstetric danger signs had improved knowledge by 50% at the endline compared to women who did not receive the health education (Fig.
Percentage of women who were knowledgeable on obstetric danger signs, baseline, and end line | PMC10403908 | ||
Effect of a health education intervention to improve knowledge of pregnant women on danger signs, complications, and birth preparedness plan readiness | COMPLICATIONS, COMPLICATION | At post-intervention, women who had received the health education intervention (intervention arm) were significantly more likely to have good knowledge on danger signs when compared with women who did not receive a health education intervention (control arm) (AOR = 10.17; [95%CI = 6.59–15.69]; p = 0.0001). Those women who had received the health education intervention (intervention arm) were significantly more likely to be knowledgeable on birth preparedness and complication plan readiness compared to those who did not receive the health education intervention (control arm) (AOR = 2.10; [1.36–3.24); p = 0.001) (Table
Effect of a health education intervention to improve knowledge of pregnant women on danger signs, complications and birth preparedness plan readinessOR: Unadjusted Odds Ratio; AOR: Adjusted Odds Ratio; CI: Confidence Interval | PMC10403908 | |
Covariate adjusted simple logistic regression of factors that influenced the utilization of antenatal care, skilled delivery, and postnatal care services | REGRESSION, WEST, SECONDARY | A covariates adjusted simple logistic regression model was used to determine the factors that influenced the utilization of antenatal care, skilled delivery, and postnatal care services after the community-based intervention. The results show that age at first marriage, education status, distance to a health facility, received health education on maternal health services, paid money to staff for ANC and delivery, and application of traditional remedies during pregnancy or delivery were factors that were associated with at least four ANC visit times, skilled delivery and PNC uptake; after adjusting for confounding variables in the model (Table The odds of at least four ANC visits, skilled delivery, and PNC attendance were significantly higher among women in the intervention group (AOR = 3.49, CI: 1.76–7.83), (AOR = 5.22, CI: 2.88–12.01), and (AOR = 3.82, CI: 1.81–8.97) respectively compared to the control site. Women who had attained tertiary education were 2.38 times more likely to attend ANC at least four times when compared with women with no formal education (AOR = 2.38; [95%CI = 0.09–1.67]; p = 0.022).Regarding skilled birth attendance, age at first marriage, education status, distance to a health facility, received HIV test results during pregnancy, and application of traditional remedies during pregnancy or delivery were the factors that influenced women to utilize skilled birth services; after adjusting for confounding variables. Women who have attained primary and secondary levels of education were 4.71 and 7.91 times, respectively, more likely to have skilled birth attendance compared to women with no formal education (AOR = 4.71; [95%CI = 1.13–19.54]; p = 0.033) and (AOR = 7.91; [95%CI = 0.86–72.62]; p = 0.031) respectively (Table Distance to a health facility, receiving HIV test results during pregnancy and paying money to staff for ANC and delivery were the factors that influenced women to utilize PNC services. Women who travelled less than 5 km to a health facility had significantly higher odds of attending ANC at least four times (AOR = 2.58; 95%CI: 1.31–5.07; p = 0.026), skilled delivery (AOR = 3.55; [95%CI = 1.49–8.72]; p = 0.038), and PNC (AOR = 3.47; [95%CI = 1.32–9.01]; p = 0.026) compared to women who travelled more than 5 km to reach a health facility. Similarly, women who received HIV test results during pregnancy were 3.45 times more likely to attend ANC and PNC compared to those who did not receive HIV test results during pregnancy (AOR = 3.45; [95%CI = 1.54 − 7.75]; p = 0.004) (Table
Covariate adjusted simple logistic regression of factors that influenced the utilization of antenatal care, skilled delivery, and postnatal care services in two selected remote districts of the Upper West Region after the community-based intervention (2019–2020) | PMC10403908 | |
Effect of a health education intervention on pregnant women’s attitudes towards, and practices related to the use of ANC and skilled delivery services | At post-intervention, women who received the health education intervention on skilled delivery were 3 times more likely to have a positive attitude towards skilled delivery compared to women who did not receive the health education intervention on skilled delivery (AOR = 3.34; 95%CI: 2.12–5.25; p = 0.001). Moreover, at post-intervention, women who received the health education intervention in practice related to ANC and skilled delivery had significantly increased odds to utilize ANC (AOR = 4.18; 95% CI = 2.48–7.04; p = 0.001) and skilled delivery services (AOR = 3.90; 95% CI = 1.83–8.29; p = 0.001) compared to women who did not receive the health education intervention (Table
Effects of a health education intervention on pregnant women’s attitudes and practice towards the use of ANC and skilled delivery in postintervention | PMC10403908 | ||
Impact of community participation and stakeholder engagement to improve community support to enhance maternal health outcomes | In the intervention area, 83.5% of women made four or more antenatal care visits during their last pregnancy at baseline and its uptake significantly increased to 90.0% (Diff-in-diff=-3.2; t = 29.69; p < 0.0001) at the end line. The Difference-In-Difference (DID) analysis revealed a net improvement of 6.5% in the intervention area with respect to changes in the control area. Regarding the place of delivery in the intervention area, 88.5% of the women had institutional delivery at baseline and its uptake improved to 97.5% at the end line. The analysis revealed a significant net improvement of 9.0% (t = 47.84; p < 0.001) after the intervention in the intervention area with respect to changes in the control area. Moreover, the findings from the end-line survey showed that in the intervention area, 96.7% (Diff-in-diff=-19.40; t = 29.69; p < 0.001) improvement in PNC visits was found while 77.3% improvement among women in the control area. The analysis revealed a significant net improvement of 19.4% in the intervention area over the control area (Table
Impact of intervention on safe maternal care practices at baseline and post-intervention | PMC10403908 | ||
Discussion | COMPLICATIONS, PREGNANCY COMPLICATIONS | The main issue that this study tried to answer was whether community-level social and behavioral change, interaction with Maternal Health Promoters or Agents and community involvement had an effect on the use of maternal health care. Additionally, if there were any differences between the research arms that were the consequence of other factors. The outcomes of the randomized controlled study showed that the social and behavior modification intervention at the community level significantly increased the use of MHS.The inferential analysis supported the hypothesis that women who received prenatal health education about the value of using MHS and could remember learning about pregnancy complications were more likely to attend ANC and had a higher likelihood of giving birth in a medical facility than those who did not. The relationship between receiving maternal health care information about pregnancy issues during ANC, having a baby in a hospital, and PNC was also highly significant. This finding is consistent with several other studies on the association between access to health information and the adoption of healthy behaviors. In a similar vein, Mageda and Mmbaga discovered in Tanzania that women who received advice from healthcare professionals to deliver at a healthcare facility had a higher likelihood of doing so [This is also related to two constructs of the Health Belief Model - perceived severity and cues to action, which state that individuals are more likely to take up positive health behaviors when they perceive a condition to be severe. In this sense, pregnant women who get information on pregnancy complications might be afraid of the complications they are likely to face when they deliver at home.An improvement in the utilization of maternal healthcare services (at least four ANC visits, institutional delivery, and at least four PNC visits) was noted in the current study. This change is mostly attributable to the effectiveness of the strict intervention measures used. We found a relationship between educational level and propensity to use MHS (ANC, facility delivery, and PNC). Maternal education affects the use of maternal health services like ANC, facility delivery, and PNC, according to numerous research from Bangladesh, [There are various explanations for the relationship between formal education and MHS uptake. First of all, educated women are better able to understand the health messages that will be distributed during ANC as well as those that are distributed through other media, such as newspapers, billboards, and other forms of mass communication [Some demographic factors such as mothers’ age and distance to health facilities remain critical and could explain the low uptake of the intervention [ | PMC10403908 | |
Limitations and strengths of the study | EVENTS | The findings from this study provide important considerations for advocacy. There was a likelihood of recall bias since the study required the women to recall previous events. The COVID-19 pandemic has also impacted the research; the study sought to use focus group discussions and pregnancy classes to educate mothers. However, some sessions were canceled due to restrictions that were imposed on the social gathering. This could have also influenced the outcome of the findings. The utilization of a randomized controlled study design with a comparison group and pre-and post-intervention assessment to detect associations is an essential strength of our study. The employment of community maternal health agents in promoting the utilization of maternal health care services is feasible and can be effective, according to the analysis. | PMC10403908 | |
Conclusion | To increase pregnant women’s awareness of and use of maternal healthcare services, the community-based integrated intervention method can be beneficial. In northern Ghana, the maternity care results and women’s household decision-making behavior had a decreased correlation. However, engaging pregnant mothers and family members led to improvements in women’s decision-making and the uptake of maternal health services.For any community health program to have an impact, it may require an effective social and behavior change, communication drive, and the involvement of community members. Linking community health care workers and Community Maternal Health Agents was pivotal for effective outcomes as demonstrated in this present study. Strengthening community-based services in poor and remote districts in deprived areas through the support of community health workers and Community Maternal Health Agents or volunteers is a potentially effective intervention that contributes to increasing coverage of maternal and newborn health interventions. The observed findings in this study are suggestive of the important role of health promotion campaigns in the improvement of community health systems for remote populations.The Ghana Health Service in the two districts should use appropriate health education tools to improve knowledge of the importance of the utilization of core maternal health services (ANC, SD, PNC). The implementation of such a strategy should take into account training community volunteers nominated from each subdistrict/community called Maternal health service assistants/Agents (MAHSA). These volunteers should be equipped and linked to health facilities in each area. Moreover, midwives should reorient their caring practices toward more culturally appropriate and evidence-based maternity care. Further research should be conducted to evaluate the effect of increased service utilization rates on staff workload and quality of service in the intervention sites (Preferably through Randomized Control Surveys). | PMC10403908 | ||
Acknowledgements | The authors would like to thank the KNUST School of Public Health, the healthcare service providers, community leaders, project teams, and study participants. | PMC10403908 | ||
Authors’ contributions | Dormechele | Alex Bapula Kassim was the principal researcher and contributed to proposal development, pretesting of the questionnaires, supervising the data collectors, data entry, and the writing of the manuscript. William Dormechele contributed to data cleaning, data analysis, and manuscript preparation. Beatrice Baah Rahinatu and Clement Tiimim Yanbom contributed to proposal development, pretesting of the questionnaires, supervising the data collectors, and data entry. Isaac Kofi Yankson contributed to proposal development. Sam Kofi Newton and Easmon Otupiri directed the design and write-up of the study, including proofreading the draft manuscript. All authors have read and approved the final manuscript. | PMC10403908 | |
Funding | The authors received no specific funding for this work. | PMC10403908 | ||
Data Availability | All data generated or analysed during this study are included in this published article as supplementary file | PMC10403908 | ||
Declarations | PMC10403908 | |||
Ethics approval and consent to participate | Ethical clearance was obtained from the Kwame Nkrumah University of Science and Technology School of Committee on Human Research Publication and Ethics, Ghana (Clearance Number: CHRPE/AP/190/19). Interviewers explained to the participants the contents of a written consent form, including their right to withdraw from participating at any point during data collection. All participants provided written informed consent to participate. Also, all literate participants and legal guardians of illiterates provided written informed consent to participate. All interviews were conducted in private and every precaution was taken to ensure confidentiality. All methods were carried out in accordance with relevant guidelines and regulations. | PMC10403908 | ||
Consent for publication | Not applicable. | PMC10403908 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10403908 | ||
Abbreviations | Birth RateInstitutional-Based | COMPLICATION | Antenatal CareAdjusted Odds RatioBirth Preparedness and Complication ReadinessConfidence IntervalCommittee on Human Research Publication and EthicsCommunity Health OfficerCommunity-Based Health Planning and ServicesCommunity-based Maternal Health AgentsCrude Odds RatioCrude Birth RateInstitutional-Based DeliveryMaternal Health ServicesMaternal Mortality RatioMillennium Development GoalsPostnatal CareSkilled DeliverySub-Saharan AfricaTotal Fertility Rate | PMC10403908 |
References | PMC10403908 | |||
Aim | Edited by: Gudrun Stenbeck, Brunel University London, United KingdomReviewed by: Shihai Jia, The University of Utah, United States; Elena Canciani, University of Eastern Piedmont, Italy‡ORCID: Junbo Tu, †These authors have contributed equally to this work and share first authorshipThe aim of this clinical trial was to assess the impact of autologous concentrated growth factor (CGF) as a socket-filling material and its ridge preservation properties following the lower third molar extraction. | PMC10231034 | ||
Materials and methods | A total of 60 sides of 30 participants who had completely symmetrical bilateral impacted lower third molars were enrolled. The primary outcome variables of the study were bone height and width, bone density, and socket surface area in the coronal section. Cone beam computed tomography images were obtained immediately after surgery and three months after surgery as a temporal measure. Follow-up data were compared to the baseline using paired and unpaired | PMC10231034 | ||
Results | ± | CGF sites had higher values in height and width when compared to control sites (Buccal wall 32.9 ± 3.5 vs 29.4 ± 4.3 mm, Lingual wall 25.4 ± 3.5 vs 23.1 ± 4 mm, and Alveolar bone width 21.07 ± 1.55vs19.53 ± 1.90 mm, respectively). Bone density showed significantly higher values in CGF sites than in control sites (Coronal half 200 ± 127.3 vs -84.1 ± 121.3 and Apical half 406.5 ± 103 vs 64.2 ± 158.6, respectively). There was a significant difference between both sites in the reduction of the periodontal pockets. | PMC10231034 | |
Conclusion | CGF application following surgical extraction provides an easy, low-cost, and efficient option for alveolar ridge preservation. Thus, the use of CGF by dentists during dental extractions may be encouraged, particularly when alveolar ridge preservation is required. | PMC10231034 | ||
Clinical trial registration | TCTR | TCTR identification, TCTR20221028003. | PMC10231034 | |
Introduction | loss of alveolar bone | One of the most critical competencies in advanced dentistry is alveolar ridge preservation (ARP) after exodontia. The loss of alveolar bone may be attributed to a variety of factors (The mechanism of extraction socket healing is characterized by internal changes that result in the formation of the bone inside the socket and external changes that result in the reduction in the height and width of the alveolar ridge (Platelets are a major source of autogenous growth factors (At present, there is only one publication on the implications of CGF combined with bone graft materials on alveolar ridge preservation ( | PMC10231034 | |
Material and methods | TCTR | SAND IMPACTION | This prospective, split-mouth, randomized, single-blind, clinical study was conducted in accordance with the Helsinki Declaration at the outpatient clinic department of oral surgery-hospital of Stomatology, Xian Jiaotong University from 25 June 2022 to 20 October 2022. This trial protocol was reviewed and approved by the Hospital of Stomatology’s institutional ethics committee at Xian Jiaotong University, in Xian, China, (xjkqII[2022] No: 033). In addition, it was registered with the TCTR identification number TCTR20221028003 at the Thai Clinical Trials Register-Medical Research Foundation of Thailand and written informed consents were obtained from all participants. For this study, a total of 60 sides of 30 patients (16 men/14 women) within the age group of 19 to 35 years (average age of 25 years) were included in the study. The following demographic and clinical characteristics were collected: age, gender, and impaction type Lower third molar extraction. | PMC10231034 |
Sample size calculation | The sample size was determined using the G*power 3.0.10 software. The required minimum sample size was 24 subjects for each group. This demonstrated that a target significance value of 0.05 would need a sample size of 30 subjects (30 test sides and 30 control sides) to have 85% power to detect a statistical difference between the CGF and control sites. Additionally, it was conducted consistent with previous comparable studies ( | PMC10231034 | ||
CGF preparation | Fresh venous blood | Fresh venous blood from patients was used to collect autologous CGF samples. They were divided into two clean 10 ml tubes without adding any anticoagulants, and they were centrifuged immediately (Preparation of CGF. | PMC10231034 | |
Randomization | An opaque, sealed envelope ( | PMC10231034 | ||
Study variables | SECONDARY | The application of CGF is regarded as the study’s main variable.The primary outcome variables of the study were bone height and width, bone density, and socket surface area.The secondary outcome variable was the periodontal pocket of the second molars. | PMC10231034 | |
Surgical procedure | tooth separation | BLOOD | The same surgical protocol as in our previous study (Each patient had a radiologic examination, including a panoramic radiograph before surgery (Blood was collected from patients.Patients gargled with 0.12% chlorhexidine gluconate as an antiseptic mouthwash for one minute.The root surfaces of lower second molars were scaled and root planed to achieve a smooth surface. Then, CGF fibrin gel was injected into the second molar pockets of CGF sites.Modified Ward’s Incision (We performed bone removal, tooth separation and extraction, and socket irrigation.We placed CGF in the extracted sockets of CGF sites which were randomly selected (We allowed natural healing to occur after extraction in control sites.We sutured the wound for both sockets (We prescribed antibiotics, anti-inflammatory analgesics, and antibacterial mouthwash.We gave patients instructions for postoperative care.One week following the surgery, the sutures were removed, and the wound was gently irrigated with saline.We carried out a postoperative follow-up on the 7 | PMC10231034 |
Clinical features assessment | The assessment of the periodontal pockets of the second molars was done before surgical extraction and after 3 months using the UNC-15 periodontal probe ( | PMC10231034 | ||
Radiographic features assessment | CREST | A cone beam computed tomography (CBCT) was taken immediately after extraction (C1), followed by a CBCT three months later (C2) as a temporal measure (Measurements methodology Buccal and lingual alveolar bone heights were measured as the vertical distances between the horizontal tangent line of the lower border of the mandible and the crest of the buccal and lingual socket walls, respectively (Bone density was measured as the mean Hounsfield units (HU) within a 16mm | PMC10231034 | |
Data analysis | The Statistical Package for Social Sciences (SPSS) version 25 (Chicago, USA) was used to compute descriptive and analytical statistics. Paired | PMC10231034 | ||
Results | In this clinical trial, 30 patients (16 men and 14 women) with an average age of 25 years had surgical extraction of both of their impacted lower third molars in a single visit at the outpatient clinic department of oral surgery-Hospital of Stomatology, Xian Jiaotong University. We used the lower third molar region as a study model. In terms of resorption, the buccal wall, lingual wall heights, and alveolar bone width showed a statistically significant reduction in the height and width of control site C2 when compared to baseline C1 of the same site (C1 31.4 ± 4.5 vs C2 29.4 ± 4.3 mm, C1 26.4 ± 4.2 vs C2 23.1 ± 4 mm, C1 20.51 ± 1.82 vs C2 19.53 ± 1.9 mm, respectively), while CGF sites C2 showed a significant increase in the wall height and width (C1 30.9 ± 3 vs C2 32.9 ± 3.5 mm, C1 23.7 ± 3.7 vs C2 25.4 ± 3.5 mm, C1 20.87 ± 1.61 vs C2 21.07 ± 1.55 mm, respectively). The CGF site had higher values in height and width when compared to the control site (Buccal wall The intra‐ and inter‐sites comparisons are shown in (a, b & c: Comparison of Buccal and lingual walls height and alveolar bone width in terms of mean±standard deviation at different time intervals in both sites.Pa, b & c: Comparison of bone density in the cervical and apical thirds of the socket and socket volume using Mann –Whitney test.Comparison of periodontal pocket of second molar at different time intervals using Chi-Square test.P | PMC10231034 | ||
Discussion | osseous defect, tooth | The 1980s saw the introduction of bone grafts in fresh sockets for ARP (Thus, novel bio-active methods have been devised to counteract the limitations of previous bone graft substances. Autogenous growth factors are mostly derived from platelets. Growth factors such as PRP, PRF, and CGF are bioactive proteins that regulate the mechanism of bone and soft tissue regeneration (The current prospective, split-mouth, randomized, controlled clinical trial confirmed that sockets grafted with CGF had better preservation of the alveolar ridge and a reduction of periodontal pocket depth, compared to natural healing (The comparison between both sides immediately after extraction, followed by a CBCT three months later. In terms of bone resorption, the present findings showed significant differences (P<.001) for resorption between C1 and C2 in the control site; buccal wall, lingual wall heights, and alveolar bone width showed a statistically significant reduction in the control site C2 when compared to baseline C1 of the same site, while CGF sites showed a significant increase of the wall heights and width. This emphasizes the outcomes of previous studies, one of which reported that the application of CGF may reduce both vertical and horizontal bone resorption after posterior tooth extraction (In terms of bone density, Ma et al. (Jung et al. (Based on a slew of studies, traditional therapy for the extraction of impacted third molars often leads to the development of an osseous defect at the distal aspect of the second molar, which may need a surgical repair later (In summary, compared to PRP and PRF, CGF contains more growth factors ( | PMC10231034 | |
Conclusion | Extracted sockets grafted with CGF showed a good and successful outcome with regard to alveolar ridge preservation. CGF application following surgical extraction provides an easy, low-cost, and efficient option for alveolar preservation, considering its biocompatibility, resilience, and availability. Thus, the use of CGF by dentists during dental extractions may be encouraged, particularly when alveolar ridge preservation is required. | PMC10231034 | ||
Data availability statement | The original contributions presented in the study are included in the article/ | PMC10231034 | ||
Ethics statement | The study protocol was reviewed and approved by the institutional ethics committee at the Hospital of Stomatology, Xian Jiaotong University, Xian, China. The patients/participants provided their written informed consent to participate in this study. | PMC10231034 | ||
Author contributions | SE, HY | SE, HY, and HC contributed to data collection, interpretation of data, designing the study, and writing the original manuscript. All other authors have critically revised the manuscript and have approved the final manuscript prior to its submission. | PMC10231034 | |
Acknowledgments | The authors would like to thank Dr.Yao Jie, Dr.Omar Al-aromy, Dr.Bassam Abo-Taleb, Dr.Mubarak Mashrah, and Dr.Nawaf Al-Mekhlafy for their consultations and assistance in accomplishing this study. | PMC10231034 | ||
Abbreviations | CGF, Concentrated growth factors; PRF, Platelet rich fibrin; PRP, Platelet rich plasma; ARP, alveolar ridge preservation; C1, a cone beam computed tomography taken immediately after extraction; C2, a cone beam computed tomography taken after three months. | PMC10231034 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10231034 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10231034 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file.Click here for additional data file.Click here for additional data file. | PMC10231034 | ||
References | PMC10231034 | |||
Background: | RELAPSING MULTIPLE SCLEROSIS | Ofatumumab has demonstrated superior efficacy and favorable safety for up to 2.5 years versus teriflunomide in relapsing multiple sclerosis (RMS). | PMC10580679 | |
Objective: | Further characterize efficacy and safety of ofatumumab in RMS. | PMC10580679 | ||
Methods: | Efficacy set: patients randomized to ofatumumab/teriflunomide in ASCLEPIOS I/II (core). Safety set: patients who received ⩾ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS (all core), or ALITHIOS (umbrella open-label extension). Patients received continuous ofatumumab or were newly switched from teriflunomide. Data cut-off: 25 September 2021. | PMC10580679 | ||
Results: | In the efficacy set ( | PMC10580679 | ||
Conclusion: | Ofatumumab has a favorable longer-term benefit–risk profile in RMS. | PMC10580679 | ||
Trial registry: | ALITHIOS (NCT03650114): | PMC10580679 | ||
Introduction | RELAPSING MULTIPLE SCLEROSIS | Ofatumumab is a fully human, anti-CD20 monoclonal antibody (mAb) approved for relapsing multiple sclerosis (RMS) in many countries.Ofatumumab approval was based on the ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) Phase 3 studies, which demonstrated superior efficacy versus teriflunomide and a favorable benefit–risk profile up to 2.5 years.To further assess the benefit–risk profile of ofatumumab in RMS and its longer-term tolerability, patients from ofatumumab studies (ASCLEPIOS I/II,Emerging data indicate that early initiation of high-efficacy therapies for RMS improves longer-term outcomes compared with delayed initiation of, or escalation from lower efficacy therapies.We report the efficacy and safety of ofatumumab in patients with RMS, for up to 4 years. | PMC10580679 | |
Patients and methods | PMC10580679 | |||
Trial design and patients | The methods of ASCLEPIOS I/II, APLIOS, and APOLITOS have been reported previously.Analysis sets and time periods.*The “newly switched ofatumumab group” comprised patients randomized to teriflunomide in ASCLEPIOS I/II (those who completed treatment were eligible to enter ALITHIOS and be switched to ofatumumab); the “continuous ofatumumab group” comprised patients randomized to ofatumumab in ASCLEPIOS I/II (those who completed treatment were eligible to enter ALITHIOS). All patients who completed study treatment in the core period were eligible to enter ALITHIOS but could withdraw prior to treatment. The efficacy analysis set comprised all patients randomized to ofatumumab or teriflunomide in ASCLEPIOS I/II, regardless of whether they completed/discontinued study treatment. The safety analysis set comprised patients who received ≥1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS. Percentages based on the number of randomized patients. The open-label extension period was defined as following the first dose of ofatumumab in ALITHIOS (below the dashed line); the core period is prior to the open-label extension (above the dashed line). Reasons for the discontinuation of study treatment are presented in | PMC10580679 | ||
Analysis populations | PMC10580679 | |||
Efficacy analysis set | death | DISEASE | Efficacy analyses consisted of data from patients randomized to ofatumumab or teriflunomide in ASCLEPIOS I/II. For three-parameter no evidence of disease activity (NEDA-3), a modified efficacy analysis set was used, excluding patients who discontinued treatment early except due to lack of efficacy or death and had NEDA-3 prior to early discontinuation. | PMC10580679 |
Safety analysis set | Safety analyses consisted of data from patients who received ⩾ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS (see | PMC10580679 | ||
Analysis of delayed versus early initiation of ofatumumab | Two analysis subgroups were defined: the “continuous ofatumumab group” and the “newly switched ofatumumab group” (see | PMC10580679 | ||
Efficacy endpoints | disability | EVENTS | The endpoints assessed were: ARR; confirmed disability worsening (CDW) events (increase from baseline Expanded Disability Status Scale score sustained for ⩾ 3/6 months (3/6mCDW) mean number of gadolinium-enhancing (Gd+) T1 lesions per scan; number of new/enlarging T2 (neT2) lesions per year; serum neurofilament light chain (sNfL) concentration at ASCLEPIOS I/II baseline, 3-/12 months post-baseline, and every 6 months thereafter; and NEDA-3 status (no 6mCDW events, no confirmed relapses, and no MRI activity (new Gd+ T1 or neT2 lesions)) in the core and extension periods, in Year 1, beyond Year 1, and overall. For further details, see | PMC10580679 |
Safety and tolerability evaluation | ADVERSE EVENT | AEs were graded according to the Common Terminology Criteria for Adverse Events version 5.0, | PMC10580679 | |
Statistical analyses | efficacy/death | REGRESSION | The ARR for the newly switched and continuous ofatumumab groups was estimated using a piecewise negative binomial model. Cumulative 3/6mCDW were assessed using Kaplan–Meier curves. Lesions per scan and adjusted annualized rates of lesions were estimated using piecewise negative binomial models. Between-group comparisons for number of relapses and number of lesions were analyzed using the Wilcoxon rank sum test. sNfL concentration was analyzed by mixed-effect modeling of repeated measures. NEDA-3 during the core and extension periods, and overall was analyzed separately using logistic regression models fitted to modified efficacy analysis sets, which excluded patients who discontinued early for reasons other than lack of efficacy/death and had NEDA-3 prior to discontinuation. | PMC10580679 |
Results | PMC10580679 | |||
Patients | PMC10580679 | |||
Efficacy subgroups: baseline demographics and reasons for discontinuation | multiple sclerosis disease, RRMS | RELAPSING REMITTING MULTIPLE SCLEROSIS, MULTIPLE SCLEROSIS, SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS | The efficacy analysis set included 1882 patients: in ASCLEPIOS I/II, 936 and 946 patients were randomized to teriflunomide and ofatumumab, respectively; 72.6% (Baseline demographics and clinical characteristics (efficacy analysis setBMI: body mass index; EDSS: Expanded Disability Status Scale; Gd+: gadolinium-enhancing; MS: multiple sclerosis; RRMS: relapsing remitting multiple sclerosis; SD: standard deviation; SPMS: secondary progressive multiple sclerosis.Data from the efficacy analysis set.Patients who completed treatment with teriflunomide in the core period were switched to ofatumumab in the open-label extension period.Treatment-naive patients had not received a prior multiple sclerosis disease modifying therapy.Not applicable, as all patients had previously received teriflunomide.Values at the baseline of the open-label extension period in the newly switched ofatumumab group reflect the teriflunomide treatment effect during the core period. | PMC10580679 |
Safety analyses | The safety analysis set included 1969 patients (see | PMC10580679 | ||
Clinical efficacy assessments | PMC10580679 | |||
Relapses | RELAPSE | The continuous ofatumumab group maintained a low ARR for up to 4 years: adjusted ARRs in the core and extension periods were 0.11 (95% confidence interval (CI): 0.08–0.13) and 0.05 (95% CI: 0.04–0.07), respectively (49.4%; Relapse data: (a) within-group comparison of ARR during the core and open-label extension periods; (b) between-group comparison of total confirmed relapses up to 4 years in the newly switched ofatumumab group and continuous ofatumumab group (efficacy analysis set).Data from the efficacy analysis set. Adjusted ARR presented as ARR (95% CI). ARR: annualized relapse rate; CI: confidence interval; EDSS, Expanded Disability Status Scale; Gd+, gadolinium-enhancing; RR: rate ratio. | PMC10580679 | |
MRI assessments | Near-complete suppression of MRI activity was maintained through 4 years in the continuous ofatumumab group. The adjusted mean number of Gd+ T1 lesions per scan in the core and extension periods was: 0.02 (95% CI: 0.02–0.03) and 0.01 (95% CI: 0.00–0.02), respectively; a reduction of 65.0% (Lesion activity on MRI in the core and extension periods: (a) within-group comparison, mean number of Gd+ T1 lesions/scan; (b) between-group comparison, mean number of Gd+ T1 lesions; (c) within-group comparison, mean annualized rate of neT2 lesions; and (d) between-group comparison, mean number of neT2 lesions (efficacy analysis set).Data from the efficacy analysis set. Panels A and C: data are presented as mean (95% CI). Data were estimated from fitting a piecewise negative binomial model for the core and open-label extension time periods with log-link, adjusted for treatment and region as factors for panels A and B, and treatment for panels C and D. For panels A and B, baseline number of T1 Gd+ lesions and patient’s age at baseline were covariates; the natural log of the number of scans with evaluable Gd+ lesion counts by period is used as offset to obtain the lesion rate per scan in each period. For panels C and D, baseline volume of T2 lesions and patient’s age at baseline were covariates; the natural log of the time-in-study (in years) by period is used as offset to annualize the lesion rate in each period. Baseline variables are from the core period baseline. CI: confidence interval; Gd+: gadolinium-enhancing; neT2: new/enlarging T2; RR, rate ratio.Continuous ofatumumab treatment led to an 87.9% reduction ( | PMC10580679 | ||
sNfL concentration | In the core period, sNfL concentration was lower with ofatumumab versus teriflunomide (concentration at Month 12: 8.03 versus 10.25 pg/mL; at Month 24: 7.96 versus 9.97 pg/mL, respectively; both | PMC10580679 | ||
Safety | PMC10580679 | |||
AE profile | death, sudden death | SUDDEN DEATH, ADVERSE EVENT | Safety was consistent with previous reportsSafety summary (safety analysis set).AE: adverse event; CI: confidence interval; EAIR: exposure adjusted incidence rate per 100 patient years; SAE: serious adverse event.Preferred terms are according to MedDRA version 24.1.Data from the safety analysis set.Data are from the core period.Data from both the core and open-label extension periods.Causes of death were: sudden death ( | PMC10580679 |
Serious infections | infections | INFECTIONS | The EAIR of serious infections remained stable (overall safety analysis set ( | PMC10580679 |
Immunoglobin G and immunoglobin M | Mean serum immunoglobin G (IgG) levels remained stable and above the lower limit of normal (LLN; 5.65 g/L), even in patients with lower IgG levels at baseline (see | PMC10580679 | ||
Neutropenia and lymphopenia | Mean lymphocyte and neutrophil levels remained stable and were above the LLN; any reductions below the LLN occurred randomly and were not persistent (see | PMC10580679 | ||
Injection-related reactions | Of 1969 patients, 487 (24.7%) and 233 (11.8%) experienced a systemic and injection site-related reaction, respectively. Most systemic and injection site-related reactions (IRRs) were Grade 1/2 ( | PMC10580679 | ||
Malignancies | malignancies | MALIGNANCIES | The incidence of malignancies was low (overall safety analysis set: 0.86%; EAIR 0.33 (95% CI: 0.20–0.53), see | PMC10580679 |
Deaths | deaths | In total, 6/1969 deaths occurred during the extension period and were reported by investigators as unrelated to ofatumumab (see | PMC10580679 | |
Discussion | infection, neuroaxonal injury, disability, reduction of | REGRESSION, EVENTS, INFECTION | This interim analysis provides new insights into the longer-term efficacy and safety of ofatumumab in RMS, supporting a favorable benefit–risk profile. The low rate of relapses with ofatumumab, as identified in ASCLEPIOS I/II,Early initiation of high-efficacy treatment for RMS improves longer-term outcomes compared with delayed initiation or switching from lower efficacy therapies.The 3mCDW and 6mCDW rates at 36 and 48 months, and the cumulative number of events, indicate that early ofatumumab treatment leads to superior disability outcomes that cannot be recovered in patients initially randomized to teriflunomide. These findings are consistent with recent studies of the longer-term benefits of early initiation of high-efficacy DMTs and disability outcomes in MS.The results also illustrate the value of switching from a low efficacy therapy to ofatumumab. In the newly switched ofatumumab group, there was a marked reduction in the ARR, together with almost complete suppression of Gd+ T1 lesion activity, a pronounced reduction of neT2 lesions, sustained reduction of neuroaxonal injury (sNfL), and increased likelihood of maintaining NEDA-3 status.Treatment with biological drugs may trigger an immune response that leads to the formation of anti-drug antibodies (ADAs).The cumulative safety data indicate that extended ofatumumab treatment is well tolerated in patients with RMS, with no new risks identified. Ofatumumab tolerability was reflected by a high level of adherence and a low rate of discontinuation throughout the core and extension periods. The EAIRs of AEs and SAEs were consistent with those previously reported in ASCLEPIOS I/II.The analyses of longer-term efficacy data presented here for the open-label ALITHIOS extension study (including data from the start of the blinded ASCLEPIOS I/II studies) are subject to the limitations of any open-label study, including lack of a comparator arm beyond the core studies. As such, the conclusions related to longer-term clinical efficacy outcomes may be limited due to the potential influence of regression to the mean. Also, as blinding is not maintained during an open-label extension study, the risk of rater assessment bias may increase.In addition, upon completion of the core studies, participation in ALITHIOS was voluntary and patients were free to discontinue due to any reason, creating the potential for selection bias. This seems unlikely, however, as an equal proportion of patients from the ASCLEPIOS I/II teriflunomide (72.3%) and ofatumumab (72.9%) arms enrolled into ALITHIOS; 88.8% of whom were still receiving ofatumumab at data cut-off. Furthermore, in ALITHIOS, the rate of discontinuations was identical for both the ofatumumab and teriflunomide arms (11.2%) and reasons for discontinuation were similar (for example, discontinuations due to AEs: 4.2% vs 3.8%, respectively; patient/guardian decision: 3.6% vs 4.3%, respectively), with low rates of discontinuations due to lack of efficacy (0.6% vs 0.9%, respectively; see The ongoing ALITHIOS study coincided with the global outbreak of COVID-19. People with MS are at increased risk of serious infection,Our findings of sustained reductions in cumulative number of relapses, MRI lesion activity, and risk of CDW with ofatumumab treatment add to a growing body of evidence that supports the value of early initiation of high-efficacy therapies in RMS, | PMC10580679 |
Supplemental Material | PMC10580679 | |||
References | PMC10580679 | |||
Abstract | PMC10281637 | |||
Introduction | Assisted partner notification (APN) safely and effectively increases partner awareness of HIV exposure, testing and case identification in community settings. Nonetheless, it has not been specifically developed or evaluated for use in prison settings where people with HIV often are diagnosed and may have difficulty contacting or otherwise notifying partners. We developed Impart, a prison‐based APN model, and evaluated its efficacy in Indonesia to increase partner notification and HIV testing. | PMC10281637 | ||
Methods | From January 2020 to January 2021, 55 incarcerated men with HIV were recruited as index participants from six jail and prison facilities in Jakarta in a two‐group randomized trial comparing the outcomes of self‐tell notification (treatment as usual) versus Impart APN in increasing partner notification and HIV testing. Participants voluntarily provided names and contact information for sex and drug‐injection partners in the community with whom they had shared possible HIV exposure during the year prior to incarceration. Participants randomized to the self‐tell only condition were coached in how to notify their partners by phone, mail or during an in‐person visit within 6 weeks. Participants randomized to Impart APN could choose between self‐tell notification or anonymous APN by a two‐person team consisting of a nurse and outreach worker. We compared the proportion of partners in each group who were notified of exposure by the end of 6 weeks, subsequently tested and HIV diagnosed. | PMC10281637 | ||
Results | Index participants ( | PMC10281637 |
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