title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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References | The CONSORT flow diagram.Violin plot on the frequency of days with any symptoms of URTI over 20 weeks of the trial. The horizontal line connects medians. Orange circles depict individual results. Error bars represent interquartile ranges.Violin plot of the medians of URTI symptoms’ average gravity scores over the 20 we... | PMC10459079 | ||
1. Introduction | In this randomized, double-blind triple-crossover study (NCT05142137), the digestive tolerance and safety of a novel, slowly digestible carbohydrate (SDC), oligomalt, an α-1,3/α-1,6-glucan α-glucose-based polymer, was assessed in healthy adults over three separate 7-day periods, comparing a high dose of oligomalt (180 ... | PMC10305601 | ||
2. Materials and Methods | PMC10305601 | |||
2.1. Study Design and Participants | In this single-centre, randomized-controlled, double-masked, three-period, three-intervention, cross-over study, participants consumed two different doses of the investigational product, or a control product, for 7 consecutive days. The study protocol was approved by the Institutional Review Board of Orange County Rese... | PMC10305601 | ||
2.2. Inclusion and Exclusion Criteria | Eligible volunteers of any gender were enrolled in the study if, following informed signed consent, they fulfilled the inclusion criteria. The key inclusion criteria were as follows: male or female, self-reported to be healthy, age 18–65 years, BMI 18.5–29.9 kg/mA further exclusion criterion was the habitual consumptio... | PMC10305601 | ||
2.3. Study Conduct and Schemes | During the different 7-day sequences with investigational product consumption (Schematic study illustration in the Given that the caloric load was 180 kcal per serving (or 720 kcal total/day), all participants received general nutritional recommendations and were asked to pay specific attention to their consumption of ... | PMC10305601 | ||
2.4. Interventional Products | The maltodextrin used in this study was “GlucidexThe oligomalt used in this study was comprised of small quantities of free sugars (<5.5% sugars, of which <0.2% is fructose and 5.3% is leucrose but zero glucose, sucrose, isomaltose, or maltose), with an average ± standard deviation DP of 16.5 ± 0.1 and a molecular weig... | PMC10305601 | ||
2.5. Endpoints | The predefined primary objective of this trial was to investigate the gastrointestinal tolerability of oligomalt when consumed daily for 7 consecutive days at two different dosages (80 g/day in combination with 100 g of maltodextrin/day and 180 g/day, respectively) as compared to maltodextrin (180 g/day), based on the ... | PMC10305601 | ||
2.6. GSRS | abdominal pain, reflux, diarrhea, constipation | GI DISORDERS | The GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. It has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion). Responses to the items range from 1 to 7, with higher scores representing more discomfort (1: No discomfort at all; 2: Slight discom... | PMC10305601 |
2.7. Bristol Stool Scale | The Bristol Stool Scale is a scale that classifies stools, ranging from the hardest to the softest, and defines 7 types of stool: hard (types 1–2), normal (types 3–5), and loose stools (types 6–7) [ | PMC10305601 | ||
2.8. Sample Size Estimation | The sample size was determined based on previous safety studies carried out with other SDCs on feasibility considerations at the investigational site, as well as considerations pertaining to not exposing participants unnecessarily to study products and study procedures. Thus, no formal sample size calculation was perfo... | PMC10305601 | ||
2.9. Blinding and Randomisation | Each participant consumed all three test products in a sequence ( | PMC10305601 | ||
2.10. Product Administration | The investigational product and the comparator were packed as individual doses of 45 g, and each individual was to take the product 4 times daily for one week. Participants were asked to dissolve the powder in 300 mL of water at room temperature and were also asked to take at least 3 of their 4 daily doses with a meal ... | PMC10305601 | ||
2.11. Data Collection | The participant-reported outcomes. i.e., questionnaires, were collected using the iMedidata patient cloud (i.e., in a remote set up), and each participant received a unique activation code that needed to be used to generate their personal unique pin. Participants were asked to report the following on a daily basis: pro... | PMC10305601 | ||
2.12. Statistical Analysis | The effects of the interventions on the GSRS (overall effect, subdomain effects, and effects related to intervention period) and Bristol Stool Scale were assessed using a linear mixed model, and they accounted for information from all 7 days of intervention. A | PMC10305601 | ||
3. Results | INFLAMMATION, ADVERSE EVENT | The first participant was screened 16 August 2021, and the third intervention sequence ended on 11 October 2021. A total of 24 subjects were enrolled, randomized, and had at least one investigational product intake. Two subjects dropped out, which resulted in 22 subjects completing all periods and sequences, reflecting... | PMC10305601 | |
3.3. Safety and Adverse Events | ADVERSE EVENT | Adverse events ( | PMC10305601 | |
4. Discussion | diarrhea | This study, in 24 healthy adult volunteers (15 females, age 34 years, BMI 22.2 kg/mIn consideration of a “minimal important difference” (MID), which is the smallest difference in the scores that is perceived as significant by the clinician or the patient [The evolutive the GSRS pattern, with tolerability developed over... | PMC10305601 | |
Limitations and Strengths | BLOOD | The key limitation of this study was that exposure to individual products did not extend beyond 7 consecutive days. However, in reality, participants were exposed to oligomalt for at least 14 days of the overall 21 days of intervention, i.e., over two study sequences, albeit with different doses and a washout period, w... | PMC10305601 | |
5. Conclusions | This study evaluated the GI tolerability of a novel SDC, oligomalt. Oligomalt was well tolerated when taken at a moderate (80 g/day) or high (180 g/day) dose, with no effect on stool frequency. An evolutive pattern with decreasing GI symptoms was seen with exposure over time, with normative scores being reached followi... | PMC10305601 | ||
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10305601 | ||
Author Contributions | Conceptualization, M.v.E., C.D., A.O. and J.S.L.-A.; Methodology, O.E.J., M.v.E., A.R., A.L. and C.D.; Project administration, J.S.L.-A.; Funding acquisition, M.v.E. and J.S.L.-A.; Formal analysis, O.E.J., A.R. and A.L.; Investigation, O.E.J. and F.D.; Resources, D.C., M.v.E., A.R., G.U., K.T. and J.S.L.-A.; Supervisio... | PMC10305601 | ||
Institutional Review Board Statement | humain | The study was conducted in accordance with the Declaration of Helsinki and approved by the “Commission cantonale d’éthique de la recherche sur l’être humain du Canton de Vaud” with reference number 2021-00585. It was registered at | PMC10305601 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10305601 | ||
Data Availability Statement | Original data supporting these results are available on request to the corresponding author for reasonable purposes. | PMC10305601 | ||
Conflicts of Interest | Odd Erik Johansen, Maximilian von Eynatten, Carmine D’Urzo, and Kate Thorne are employed by Nestlé Health Science, Lausanne, Switzerland. Delphine Curti, Andreas Rytz, Anirban Lahiry, Frederik Delodder, and Audrey Orengo are employed by Nestlé Research, Lausanne, Switzerland. Gerhard Ufheil is employed by Nestlé Resear... | PMC10305601 | ||
References | distensionAbdominal painAbdominal pain | ADVERSE EVENT, EVENTS | Effect on total score for Gastrointestinal Symptom Rating Scale by intervention, regardless of intervention sequence. The figure shows the mean (95% CI) (Subdomain scores for the Gastrointestinal Symptom Rating Scale (GSRS) by intervention, regardless of intervention sequence. The figure shows the mean (95% CI) (Total ... | PMC10305601 |
Abstract | PMC10166179 | |||
Background | tumor, PDAC, pancreatic ductal adenocarcinoma | PANCREATIC DUCTAL ADENOCARCINOMA, TUMOR | In preclinical pancreatic ductal adenocarcinoma (PDAC) models, inhibition of hepatocyte growth factor (HGF) signaling using ficlatuzumab, a recombinant humanized anti-HGF antibody, and gemcitabine reduced tumor burden. | PMC10166179 |
Methods | PDAC | Patients with previously untreated metastatic PDAC enrolled in a phase Ib dose escalation study with 3 + 3 design of 2 dose cohorts of ficlatuzumab 10 and 20 mg/kg administered intravenously every other week with gemcitabine 1000 mg/m | PMC10166179 | |
Results | toxicities | Twenty-six patients (sex, 12 male:14 female; median age, 68 years [range, 49-83 years]) were enrolled, 22 patients were evaluable. No dose–limiting toxicities were identified ( | PMC10166179 | |
Conclusion | hypoalbuminemia, edema | HYPOALBUMINEMIA, EDEMA, PANCREATIC DUCTAL ADENOCARCINOMA | In this phase Ib trial, ficlatuzumab, gemcitabine, and albumin-bound paclitaxel were associated with durable treatment responses and increased rates of hypoalbuminemia and edema.This article evaluates the safety profile and clinical efficacy of ficlatuzumab (AV-299), in combination with standard systemic chemotherapy o... | PMC10166179 |
Implications for Practice | antibody reduced, tumor, pancreatic adenocarcinoma | PROLIFERATION, TUMOR, PANCREATIC ADENOCARCINOMA | Dysregulation of the hepatocyte growth factor (HGF)/c-Met signaling pathway can lead to aberrant cell proliferation, drug resistance, and promotion of cell migration and invasion. In pre-clinical pancreatic adenocarcinoma models, ficlatuzumab, an anti-HGF monoclonal antibody reduced tumor burden in combination with gem... | PMC10166179 |
Background | human pancreatic cancer stem cell marker., PDAC, aggressive disease | PANCREATIC DUCTAL ADENOCARCINOMA, SOLID TUMORS | Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive disease with poor clinical outcomes. In a recent report, Li et al identified c-Met as a potential novel human pancreatic cancer stem cell marker.Ficlatuzumab, a humanized immunoglobulin G1 monoclonal antibody that targets HGF, is a HGF-c-Met inhibitor which... | PMC10166179 |
Methods | PMC10166179 | |||
Patients | infection, major cancer | PANCREATIC CARCINOMA, CEREBRAL METASTASES, METASTATIC PANCREATIC CANCER, INFECTION, CARDIAC DISEASE, ONCOLOGY, PERIPHERAL NEUROPATHY, CHRONIC DIARRHEA | Patients were eligible if they were 18 years of age or older and had histologically or cytologically confirmed, measurable by RECIST version 1.1, previously untreated metastatic PDAC. Other inclusion criteria were an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 and adequate bone marrow (... | PMC10166179 |
Treatment Program | tumor, death, Tumor, Cancer | TUMOR, TUMOR, ADVERSE EVENT, BLOOD, CANCER | This was a multi-center, phase Ib dose escalation study with a 3 + 3 design conducted at 2 Harvard Cancer Center sites, namely Dana-Farber Cancer Institute/Brigham Cancer Center and Massachusetts General Hospital (Diagram of patients enrolled.Radiologic tumor assessments included contrast-enhanced CT scan of the chest,... | PMC10166179 |
Statistical Analysis | Cancer | CANCER | This study evaluated the safety and tolerability of ficlatuzumab when given with standard chemotherapy with the aim of determining the maximum tolerated dose (MTD) of ficlatuzumab in combination with gemcitabine and The study (NCT03316599) was approved by the Dana-Farber Cancer Institute institutional review board and ... | PMC10166179 |
Results | PMC10166179 | |||
Patient Characteristics | Between January 2018 and April 2019, a total of 26 patients enrolled in the study. Baseline characteristics of the patients are listed in Demographics.
| PMC10166179 | ||
Treatment, DLT, and Determination of Maximum Tolerated Dose (MTD) | toxicity, DLTs | In the phase Ib study, a minimum of 3 enrolled patients per dose level was planned. No DLTs were reported in the first 3 patients enrolled at dose level 1 (ficlatuzumab 10 mg/kg) or 3 subsequent patients enrolled at dose level 2 (ficlatuzumab 20 mg/kg). Therefore, the regimen of gemcitabine 1000 mg/mIn total, 25 patien... | PMC10166179 | |
Secondary Endpoints: Response Rate, Progression-Free Survival, Overall Survival | PD | DISEASE, BEST | Of the 21 patients treated at the MTD, 19 patients met criteria for response assessment per protocol. Two patients were not evaluable because they withdrew from therapy or discontinued treatment due to physician decision. Best responses by RECIST criteria were: 6 (29%) partial responses; 12 patients (57%) with stable d... | PMC10166179 |
Treatment Exposure | death | The median duration of treatment was 7.1 months (range, 0-24.9 months); and median number of cycles started was 7 cycles (range, 1-27). Patients were followed for 6 months after removal from protocol therapy or until death, whichever occurred first. The median follow-up time was 9.1 months (range, 0.3-26.3 months). Amo... | PMC10166179 | |
Association Between Toxicities and Outcomes | toxicity, hypoalbuminemia, toxicities, peripheral edema | HYPOALBUMINEMIA, PERIPHERAL EDEMA | Since 52% of participants developed any grade hypoalbuminemia and 48% developed any grade peripheral edema while on therapy, an analysis was performed to assess the association between these toxicities and clinical outcomes. Across RR, PFS, and OS, no statistically significant associations were identified among patient... | PMC10166179 |
Correlative Analysis | tumor | DISEASE, TUMOR | We evaluated 11 serum sample pairs for HGF prior to initiation of treatment on days 1 and 1 of cycle 2. Of the 11 pairs, 9 were evaluable for response at MTD. There was no association between C1D1 HGF values and best response (Fourteen of the patients had sufficient samples from pre-treatment tissue biopsies for immuno... | PMC10166179 |
Discussion | hypoalbuminemia, Edema, cancer | HYPOALBUMINEMIA, PROLIFERATION, CANCER, EDEMA, SECONDARY, METASTASES | Dysregulation of the HGF/c-Met signaling pathway can lead to aberrant cell proliferation, drug resistance, and promotion of cell migration and invasion.Edema and hypoalbuminemia are known side effects of HGF/c-Met inhibitors, including ficlatuzumab.With respect to the secondary objectives, this study showed that the ad... | PMC10166179 |
Conclusion | In this study, the recommended dose of ficlatuzumab when combined with gemcitabine and | PMC10166179 | ||
Acknowledgments | Pancreatic Cancer | PANCREATIC CANCER, CANCER, CANCER, PANCREATIC | Harvard P30 CCSG grant number. AR acknowledges support from NIH 2R01 DK060694 and NIH 5P30013696. B.M.W. acknowledges support from the Hale Family Center for Pancreatic Cancer Research, Lustgarten Foundation Dedicated Laboratory program, NIH grant U01 CA210171, NIH grant P50 CA127003, Stand Up to Cancer, Pancreatic Can... | PMC10166179 |
Statement of Ethics | Cancer | CANCER | The study was approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board IRB. The research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki. The subjects provided their WRITTEN informed consent to participate in the IRB approved protocol 17-406. B.M.W. h... | PMC10166179 |
Funding | This investigator-sponsored study received funding from AVEO Pharmaceuticals. | PMC10166179 | ||
Conflict of Interest | Alentis | ONCOLOGY | Kimberly Perez was a one-time advisory board member for Lantheus and QED/Helsinn. James M. Cleary receives research funding to his institution from Merus, Roche, and Bristol Myers Squibb; he receives research support from Merck, AstraZeneca, Esperas Pharma, Bayer, Tesaro, Arcus Biosciences, and Apexigen; he has also re... | PMC10166179 |
Author Contributions | Conception/design: K.P., A.C., C.W., S.R., B.B., K.D., J.P., A.A., M.N., A.K.R., B.M.W. Provision of study material or patients: K.P., J.M.C., C.W., T.A., L.B., P.E., M.G., L.G., J.A.M., D.R., M.B.Y., W.G., B.G., B.M.W. Collection and/or assembly of data: K.P., A.C., N.H., V.G., D.S., A.K.R., B.M.W. Data analysis and i... | PMC10166179 | ||
Data Availability | The data underlying this article are available in the article and in its online supplementary material. | PMC10166179 | ||
References | PMC10166179 | |||
Background: | mental disorder | Informal settlements are high density areas in and around cities, characterized by a lack of formal planning and basic amenities, being known in South Africa for high levels of mental disorder driven by violence, and complex social and economic challenges. In particular, young men’s poor mental health goes untreated, w... | PMC10657496 | |
Aim: | This cluster randomized controlled trial investigated the effectiveness of Stepping Stones and Creating Futures (SS/CF), a participatory gender transformative and economic empowerment intervention, on the mental health of young men living in South African informal settlement. | PMC10657496 | ||
Methods: | post-traumatic stress, anxiety, PTS | A total of 674 young men ages 18 to 30 years were recruited in 34 clusters in Durban’s urban informal settlements. Clusters were randomly allocated (1:1) to either the experimental SS/CF or control arm and participants were followed-up over 24-months. Intention-to-treat analysis based on generalized estimating equation... | PMC10657496 | |
Results: | anxiety | At end of the 24 months follow-period, anxiety (adjusted odds ratio [aOR]: 0.62, | PMC10657496 | |
Conclusion: | anxiety, PTS | SS/CF, a gender transformative and livelihoods strengthening intervention designed to address poverty and other socio-economic challenges in informal settlements reduced anxiety and PTS among men with mental health challenges living in informal settlements. | PMC10657496 | |
Introduction | Trauma, anxiety, traumatic | SECONDARY | Poor mental health continues to be pervasive in sub-Saharan Africa (SSA; Informal settlements in South Africa are contextually distinct, initially being consequences of the country’s pre-democracy regime’s discriminatory migrant labour and spatial policy, they continue to persist. Previous studies indicate that these s... | PMC10657496 |
Methods | PMC10657496 | |||
Study design | SECONDARY | Using cohort data gathered at baseline and end-line for the main trial analysis of the impact of SS/CF among young men recruited into the study, we conducted a secondary post-hoc investigation. The original data set for the trial was provided by the research team allowing extraction of relevant variables. | PMC10657496 | |
Study setting and population | This study entailed analyses of a cluster randomized controlled trial (RCT) that evaluates whether Stepping Stones and Creating Futures (SS/CF) reduces poor mental health among young men (18–30 years) in informal settlements. Clusters were identified by areas within informal settlements that were demarcated by pre-exis... | PMC10657496 | ||
Intervention and data collection | EVENTS, RECRUITMENT | SS/CF is a community-based intervention originally designed to reduce IPV (although it has components that target mental health). The Stepping Stones component is focused on gender transformation and consists of 10 three-hour sessions (30 hours total), administered by trained peer facilitators to single-sex groups of 1... | PMC10657496 | |
Randomization and sampling procedure | Stepping stones | A cluster RCT, consisting of intervention and control groups (1:1 ratio), was conducted from September 2016 to October 2018. The intervention arm was administered with SS/CF, while the control arm was on a waitlist to receive the intervention after the final data collection. Once clusters were identified, randomization... | PMC10657496 | |
Ethical consideration | The University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC043/15) and the South African Medical Research Council Ethics Review Committee (EC006-2/2015) provided ethics approval to conduct the main trial. All participants provided written informed consent. The use of data for the present study was approve... | PMC10657496 | ||
Measures | PMC10657496 | |||
Outcome variables | Anxiety, anxiety, post-traumatic stress disorder, PTSD, Trauma, post-traumatic stress | Anxiety and post-traumatic stress were the main outcomes of the study, with two validated tools being used to measure the participants’ levels of both at 12 months and 24 months. Anxiety symptoms were identified by the 7-item General Anxiety Disorder-7 (GAD-7) scale that was developed to assess levels of anxiety over t... | PMC10657496 | |
Baseline socio-demographic and other descriptors | PTSD, Trauma, trauma | DISORDERS, EVENT, EVENT, EVENTS, EVENTS | In addition to socio-demographic information (e.g. age, marital status, education and employment status) and intervention assignment (i.e. study arm), six variables are worth noting for this current investigation, as they represent some of the challenges faced in informal settlements in South Africa: food security, cri... | PMC10657496 |
Statistical analysis | anxiety, PTS | REGRESSION | First, we describe the baseline socio-demographic and clinical characteristics by study arm using descriptive statistical analysis. Second, we compared baseline socio-demographic and other baseline descriptors based on Chi-square to examine whether randomization was successful. Third, we conducted intention-to-treat (I... | PMC10657496 |
Baseline socio-demographic and clinical characteristics by study arm | At baseline almost two-thirds of the men were unemployed ( | PMC10657496 | ||
Impact of SS/CF on mental health | Our analyses (Mental health outcomes at 12 and 24 months according to intervention based on intention-to-treat based on generalized estimating equation.Mental health outcomes at 12 and 24 months according to intervention based on intention-to-treat based on generalized estimating equation after multiple imputation with... | PMC10657496 | ||
Discussion | anxiety, PTS | RECRUITMENT | Our study examined the impact of SS/CF on young men’s mental health in urban informal settlements, the intervention being originally designed to reduce men’s perpetration of IPV (There are three potential mechanisms through which SS/CF impacted on anxiety and PTS. The first possible explanation could be due to it being... | PMC10657496 |
References | PMC10657496 | |||
Abstract | Ama Johal, Muftah Shagmani, Omar Alfuraih and Ian Arad contributed equally to this work. | PMC10803043 | ||
Background and objectives | PLAQUE | To-date, there is no evidence comparing the long-term efficacy of powered and manual toothbrushes in adolescents undergoing fixed appliance treatment. The trial compared the efficacy of manual versus powered toothbrush in controlling plaque and gingival health in patients undergoing fixed treatment in respect of both t... | PMC10803043 | |
Trial design | This was a randomized, parallel, controlled single-blind clinical trial, undertaken in a hospital setting, for which the consolidated standards of reporting trials guidelines were followed. | PMC10803043 | ||
Methods | bleeding | BLEEDING, PLAQUE | Ninety-two adolescent participants planned to undergo fixed appliance therapy, were randomly assigned to either a manual or powered toothbrush, with allocation concealment. The outcome measures were plaque and gingival indices and bleeding on probing, assessed at baseline (prior to fixed appliance), one-, six- and 12-m... | PMC10803043 |
Results | The final sample included 84 participants, aged 12-18 (M=14.1, SD=1.93) years, with 40 (47%) were using a manual and 44 (52%) a powered toothbrush. The intervention (powered vs. manual toothbrush) itself appeared insignificant with regards to the gingival index (GI) (95%CI −0.1 – 0.03; | PMC10803043 | ||
Conclusion | PLAQUE | Whilst no differences were found between manual and powered toothbrushes in controlling plaque and gingival health, in participants undergoing fixed orthodontic treatment, both were suboptimal and highlighted the need for greater patient support and monitoring. | PMC10803043 | |
Trial registration details | PMC10803043 | |||
Introduction | orthodontic, gingivitis, caries, tooth brushing | GINGIVITIS, DENTAL PLAQUE, CARIES, PERIODONTAL DISEASE, PLAQUE | Bacteria present in dental plaque are the primary aetiological agents in caries and periodontal disease. Therefore, effective tooth brushing remains an essential health practice to minimize plaque accumulation. Patients undergoing orthodontic treatment have greater difficulty in maintaining optimal oral hygiene levels,... | PMC10803043 |
Materials and methods | PMC10803043 | |||
Participants, eligibility criteria, and setting | carious lesions | Ethical approval for this single-centre, hospital-based trial was granted by the National Research Ethics Services Committee (REC reference number: 14/LO/0003) and the trial registered (26.06.2014) with International Standard Randomised Controlled Trials Number (The study population was drawn from those due to receive ... | PMC10803043 | |
Trial design and setting | This was a randomized, parallel, controlled single-blind clinical trial, undertaken in a hospital setting, for which the consolidated standards of reporting trials (CONSORT) guidelines were followed [ | PMC10803043 | ||
Randomization, allocation concealment, and blinding | Participants who fulfilled the above selection criteria were identified and invited to take part in this study. Written informed consent and assent were obtained from the parent/guardian and participant, respectively. They were subsequently randomized (46 in each group) into either the intervention test (powered toothb... | PMC10803043 | ||
Interventions | CAVITY | Following appliance placement, the research nurse provided participants with either an Omron-powered sonic toothbrush (PT) and Triple Clean head (ProClinical A1500, Omron Corporation, Kyoto, Japan) or an Oral B Indicator Medium 35 manual toothbrush (MT; Proctor and Gamble, USA). The powered toothbrush heads and manual ... | PMC10803043 | |
Outcome measurements | gingivae, bleeding, inflammation, palate, tooth, trauma | PLAQUE, INFLAMMATION, BLEEDING, PLAQUE | Plaque and gingival scores assessed at baseline, before fixed appliance placement (T0), 1 month (T1), 6 months (T2), and 1 year (T3) along with an oral soft and hard tissue safety assessment. Data were collected by two trained and calibrated investigators (M.S. & O.A.) in the use of plaque and gingival indices.Plaque i... | PMC10803043 |
Statistical analysis | PMC10803043 | |||
Sample size calculation | According to the trial carried out by Clerehugh | PMC10803043 | ||
Statistical methods | ’s mouth, bleeding, Tooth, tooth | REGRESSION, BLEEDING, PLAQUE | Data analysis was carried out using JMP®, Version 14 Pro (SAS Institute, Inc., Cary, NC, 1989-2019) software. The data (PI, GI, and BoP) were tested for normality and an intention-to-treat analysis was applied. The three primary outcomes (plaque scores, gingival index, and bleeding on probing) were collected per tooth,... | PMC10803043 |
Examiner alignment and assessment | tooth | RECRUITMENT | During examiner alignment, both examiners (M.S. and O.A.) and a research nurse (S.S.) were instructed and coached in the proper use of the outcome measurements (GI, BoP, and PI), before participant recruitment to the trial [A clinical assessment study to assess intra-examiner reproducibility of the measurements, was pe... | PMC10803043 |
Results | PMC10803043 | |||
Participant flow | RECRUITMENT, RECRUITMENT | Recruitment commenced in July 2014 and was completed in November 2017 (a 3-year 4-month rolling recruitment period). The recruitment and follow-up of all participants can be seen in the CONSORT flow diagram ( | PMC10803043 | |
Baseline data | bleeding | BLEEDING, PLAQUE | The final sample included 92 participants in the ages of 12–18 years (Baseline demographic and clinical characteristics of the sample (Descriptive statistics for gingival, bleeding on probing, and plaque indices for manual and power toothbrushes groups at each time point. | PMC10803043 |
Numbers analysed for each outcome | For the MT group, a total of 46, 41, 40, and 40 participant’s data were analysed at T0, T1, T2, and T3, respectively ( | PMC10803043 | ||
Changes in outcome measures | ’s mouth, bleeding, tooth | REGRESSION, PLAQUE, BLEEDING, PLAQUE | The following section presents a separate analysis for each dependent variable: GI, PI and BoP from baseline (T0; immediately before placement of the fixed appliance) to 12-months (T3; Mixed-effects multiple linear regression for Gingival Index.
Model includes fixed effects for tooth and its interaction with time and t... | PMC10803043 |
Gingival index | REGRESSION | The mixed-effects multiple linear regression was used to estimate the difference in GI scores across all participant teeth ( | PMC10803043 | |
Bleeding on probing | PMC10803043 | |||
Plaque Index | In the mixed effects model for PI ( | PMC10803043 |
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