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Acknowledgements | None. | PMC10061705 | ||
Authors’ contributions | & L.C. | All authors made substantial contributions to the study. Study concept and design: Y.S. & L.C.; literature search: Y.S. W.L. & Z.Z.; acquisition of data: W.L., Z.Z., S.M.L., Y.Y.C.& L.Y.; statistical analyses: Y.S. & L.C.; drafting of the manuscript: Y.S. & L.C.. All authors commented on previous versions of the manusc... | PMC10061705 | |
Funding | None. | PMC10061705 | ||
Availability of data and materials | The research data has been uploaded to the database. The public access to the database is open. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10061705 | ||
Declarations | PMC10061705 | |||
Ethics approval and consent to participate | Ethics approval has been granted by the Institutional Review Board of Shengjing Hospital of China Medical University, Shenyang, China (approval number: 2021PS511K, approval date:12/05/2021). Written informed consent was obtained from all subjects participating in the trial. The trial protocol followed the Declaration o... | PMC10061705 | ||
Consent for publication | Not applicable. | PMC10061705 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10061705 | ||
References | PMC10061705 | |||
1. Introduction | MSI, cancers, colorectal cancer, CRC, heterogeneous diseases, NB, deaths, Colorectal cancer | COLORECTAL CANCER, CANCERS, MICROSATELLITE INSTABILITY, MAY, REGRESSION, COLORECTAL CANCER | Academic Editor: Xing NiuChemotherapy is not recommended for patients with deficient mismatch repair (dMMR) in colorectal cancer (CRC); therefore, assessing the status of MMR is crucial for the selection of subsequent treatment. This study is aimed at building predictive models to accurately and rapidly identify dMMR. ... | PMC9969972 |
2. Materials and Methods | PMC9969972 | |||
2.1. Study Population | CRC | MAY, COMPLICATIONS | Retrospective analysis of 2279 patients of CRC with confirmed diagnosis at Wuhan Union Hospital from May 2017 to December 2019 was done. Patients with the following conditions were excluded from the study: (i) no MMR status outcome, (ii) no complete clinical data, and (iii) history of radiotherapy and chemotherapy prio... | PMC9969972 |
2.2. Data Collection | squamous cell carcinoma antigen, tumor | TUMOR | Baseline clinicopathological information on the patients obtained from the hospital's medical records included the following serum tumor markers: carcinoembryonic antigen (CEA), glycoantigen 19-9 (CA19-9), glycoantigen 12-5 (CA12-5), glycoantigen 72-4 (CA72-4), glycoantigen 15-3 (CA15-3), alpha-fetoprotein (AFP), serum... | PMC9969972 |
2.3. Four Machine Learning Classifiers and a Conventional Logistic Regression Model | NB | REGRESSION | In this study, we built four machine learning models (extreme gradient boosting (XGBoost), support vector machine (SVM), naive Bayes (NB), and random forest (RF)) and a conventional logistic regression (LR) model using the caret package for R language (version 6.0-90) to diagnose dMMR discriminatively. An analysis of c... | PMC9969972 |
2.4. Data Analysis | Continuous variables between the dMMR and pMMR groups were analyzed using the Student | PMC9969972 | ||
3. Results | PMC9969972 | |||
3.1. Patient Characteristics | tumor-related | We screened 3566 patients with CRC, and 2279 eligible patients were enrolled in our study. All eligible patients were recruited from Wuhan Union Medical College Hospital. In a ratio of 7 : 3, 1595 patients were allocated to the training group and 684 to the testing group. The detailed screening process is shown in The ... | PMC9969972 | |
3.2. Construction of Predictive Models | Twenty-three variables were initially included based on the simple clinicopathological data of the patients. The collinearity between variables was excluded before modelling. The results of the variable correlation analysis ( | PMC9969972 | ||
3.3. Performance of Models | CRC | The 2279 patients with CRC were randomly divided into training and test sets in a 7 : 3 ratio. The receiver operating characteristic (ROC) curve was used to evaluate the performance of the four machine learning models and LR model. As shown in | PMC9969972 | |
3.4. Variable Importance Analysis | REGRESSION | We performed feature importance analysis for the variables selected using LASSO regression and random forest, respectively, and the results are displayed in Figures | PMC9969972 | |
4. Discussion | MSI, tumor, colorectal cancer, CRC | REGRESSION, TUMOR, COLORECTAL CANCER | CRC remains a major healthcare burden with a high mortality rate worldwide [In previous studies, [Few studies have built machine learning models based on simple clinicopathological indicators to predict dMMR or MSI status in patients with CRC. Notably, several studies have been reported to use deep learning methods bas... | PMC9969972 |
5. Conclusions | tumor, CRC | REGRESSION, TUMOR | In this study, we built four sets of machine learning models and a conventional logistic regression model to predict the lack of DNA MMR in patients with CRC based on simple clinicopathological indicators. Our results show that machine learning models can be incorporated with accurate and consistent predictive behavior... | PMC9969972 |
6. Limitations | tumor | TUMOR, INFILTRATION | Our study has some limitations. First, the population in our cohort comprised of persons from one region of China (Wuhan), which may limit the generalizability of the predictive models and require further validation in patients from different geographic regions. Second, this was a nonrandomized retrospective analysis. ... | PMC9969972 |
Acknowledgments | This study was supported by the National Natural Science Foundation of China (grant number 82170678), Hubei Province Key Research and Development Program of China (Science and Technology Innovation Special Project) (grant number 2021BAA04 4), and Wuhan Strong Magnetic Field Interdisciplinary Fund (grant number WHMF2021... | PMC9969972 | ||
Data Availability | The datasets used and/or analyzed during the current study are available from the corresponding authors on reasonable request. | PMC9969972 | ||
Ethical Approval | This study was performed in line with the principles of the Declaration of Helsinki. Studies involving human participants were reviewed and approved by the Ethics Committee and the Institutional Review Committee of Wuhan Union Medical College (No.2018-S377). | PMC9969972 | ||
Consent | Informed consent was obtained from all individual participants included in the study. The recruited volunteers were requested to sign an informed consent form. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article. | PMC9969972 | ||
Disclosure | Some part of our manuscript was previously published as a preprint as per the following link: | PMC9969972 | ||
Conflicts of Interest | The authors declare that they have no competing interests. | PMC9969972 | ||
Authors' Contributions | Conceptualisation was done by Zhenxing Jiang, Yinghao Cao, Lizhao Yan, and Shenghe Deng. Acquisition of data, analysis, and interpretation of data were done by Junnan Gu, Le Qin, Fuwei Mao, Yifan Xue, Fumei Shang, and Wentai Cai. Writing—original draft—was done by Zhenxing Jiang, Shenghe Deng, Junnan Gu, and Le Qin. Wr... | PMC9969972 | ||
Supplementary Materials | tumor, NB | REGRESSION, COLORECTAL CANCER, TUMOR | Analytical diagram of the percentage of the situation within each variable. We performed a statistical analysis of the individual signs of the included patients, which is presented in the form of a bar chart that clearly shows the proportion of the number of patients for each variable.Click here for additional data fil... | PMC9969972 |
Subject terms | Sheehan Disability, post-traumatic stress disorder, PTSD, DSM-5 | SECONDARY | This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered P... | PMC10579091 |
Main | trauma, PTSD, chronic sexual abuse, stress disorder | Post-traumatic stress disorder (PTSD) is a serious neuropsychiatric condition affecting approximately 5% of the US population each yearMounting evidence supports substituted phenethylamine 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) as a treatment for PTSDDue to disparities in trauma exposure, gender-d... | PMC10579091 | |
Results | PMC10579091 | |||
Demographics and baseline characteristics | MAY | Participants were recruited from 21 August 2020 to 18 May 2022 (last participant visit on 2 November 2022). Overall, 324 individuals were screened, and 121 were enrolled. Of these, 17 individuals did not meet enrollment confirmation after initiation of preparation therapy, and 104 were confirmed for randomization: 53 w... | PMC10579091 | |
Primary outcomes | PTSD | MDMA-AT significantly attenuated PTSD symptomology versus placebo with therapy, as measured by a reduction in CAPS-5 total severity score from baseline to 18 weeks. Mixed models for repeated measures (MMRM) analysis of the de jure estimand showed a least squares (LS) mean (95% confidence interval (CI)) change of −23.7 ... | PMC10579091 | |
Secondary outcomes | Sheehan Disability | MDMA-AT significantly mitigated clinician-rated functional impairment, as measured by a reduction in the Sheehan Disability Scale (SDS) from baseline. MMRM analysis of the de jure estimand revealed that the LS mean change (95% CI) in SDS total scores was −3.3 (−4.03, −2.60) with MDMA-AT versus −2.1 (−2.89, −1.33) with ... | PMC10579091 | |
Exploratory outcomes | In the MDMA-AT group, 45 of 52 (86.5%) participants were responders with a clinically meaningful improvement at 18 weeks after baseline, defined as a ≥10-point reduction in CAPS-5 total severity score, versus 29 of 42 (69.0%) in the placebo with therapy group (Fig. | PMC10579091 | ||
Discussion | psychiatric, PTSD, comorbid personality disorders | CARDIOVASCULAR DISEASE | In this confirmatory phase 3 study of participants with moderate to severe PTSD, MDMA-AT significantly improved PTSD symptoms and functional impairment, as assessed by CAPS-5 and SDS, respectively, compared to placebo with therapy over 18 weeks. Notably, 45 of 52 (86.5%) participants treated with MDMA-AT achieved a cli... | PMC10579091 |
Methods | PMC10579091 | |||
Study design and oversight | PTSD | This multi-site, randomized, double-blind, placebo-controlled study assessed the efficacy and safety of MDMA-AT versus placebo with therapy in participants diagnosed with moderate or severe PTSD ( | PMC10579091 | |
Participants | PTSD, DSM-5 | After written informed consent, participants were screened for eligibility. Adults (≥18 years of age) meeting the full DSM-5 criteria for current PTSD per CAPS-5 assessment | PMC10579091 | |
Randomization and masking | Participants were randomized in a 1:1 allocation and in a blinded fashion to the MDMA-AT and placebo with therapy groups, stratified by clinical site. Randomization was managed via an interactive web randomization system (IWRS) (IT Clinical version 11.0.1) based on a centralized randomization schedule developed by an i... | PMC10579091 | ||
Procedures | Trial procedures were consistent with MAPP1 (ref. Within the MDMA-AT group, three participants did not undergo dose escalation in experimental sessions 2 and 3, and two participants experienced dose administration timing errors (Supplementary Table | PMC10579091 | ||
Outcomes | ideation, death, congenital anomaly, birth defect, TEAEs, PTSD, impairment or damage, disability or incapacity, Suicidality | ADVERSE EVENTS, EVENT, SECONDARY, ADVERSE EVENT, EVENTS | Independent assessors conducted CAPS-5 and SDS outcome assessments at baseline, after experimental sessions 1 and 2 and 6–8 weeks after experimental session 3 (18 weeks after baseline) via video interviews. Primary and secondary objectives were mean change in CAPS-5 total severity and SDS scores, respectively, for MDMA... | PMC10579091 |
Statistical analysis | depression, PTSD, TEAEs | DISEASE, SECONDARY, DISORDERS, DISORDER | SAS version 9.4 (SAS Institute) was used for analyses. Sample size was calculated to achieve a power of 90% at an alpha of 0.0499.Efficacy was tested using an MMRM analysis comparing the change from baseline to 18 weeks after baseline in CAPS-5 and SDS scores between treatment groups in two-sided tests with alpha set a... | PMC10579091 |
Adverse events of special interest | ideation, sudden death, cardiac arrhythmias, overdose, syncope, seizures, MDMA abuse, self-harm | SUDDEN DEATH, CARDIAC ARRHYTHMIAS, VENTRICULAR TACHYCARDIA, ADVERSE EVENTS, TORSADE DE POINTES, VENTRICULAR FIBRILLATION AND FLUTTER, VENTRICULAR EXTRASYSTOLES | In accordance with FDA guidance, special attention was paid to a subset of adverse events, TEAESIs, relating to cardiac function, suicide risk and MDMA abuse, misuse or diversion. TEAESIs involving cardiac function that could be indicative of QT prolongation or cardiac arrhythmias were collected, including torsade de p... | PMC10579091 |
Reporting summary | Further information on research design is available in the | PMC10579091 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02565-4. | PMC10579091 | ||
Supplementary information |
CONSORT checklist, MAPP2 study collaborators, Supplementary Methods, Supplementary Figs. 1 and 2, Supplementary Tables 1–9 and Supplementary References.Reporting Summary | PMC10579091 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02565-4. | PMC10579091 | ||
Acknowledgements | CARPENTER, PBC | The authors thank all of the participants and their support networks. See the This study was funded by Multidisciplinary Association for Psychedelic Studies (MAPS) with support from the Steven and Alexandra Cohen Foundation and organized by MAPS Public Benefit Corporation (PBC). MAPS PBC was responsible for overseeing ... | PMC10579091 | |
Author contributions | S.H., B.Y.-K., C.H. and A.d.B. contributed to data analysis; these authors and J.M.M. directly accessed and collectively verified the underlying data. All authors had full access to the trial data, contributed to the interpretation of the data and contributed to writing the manuscript. The authors attest to the accurac... | PMC10579091 | ||
Peer review | PMC10579091 | |||
Data availability | The data that support the findings of this study are available from the sponsor beginning 1 year after completion of the trial. However, restrictions apply to the availability of these data, which were used under license for the current study and so are not publicly available. Data are, however, available from the auth... | PMC10579091 | ||
Code availability | Commercially available software (SAS version 9.4 or higher, SAS Institute) was used for analyses, in keeping with the statistical analysis plan. | PMC10579091 | ||
Competing interests | PBC | J.M.M. has received research support from MAPS; grants/contracts from the Veterans Administration (Merit Award) and the FDA (Research Award); has received royalties/licenses from UCLA (for a patent licensed to UCSF for cell screening); has received payment/honoraria from Stanford (for lecturing to undergraduate student... | PMC10579091 | |
References | PMC10579091 | |||
Supplementary Material | cirrhosis, end-stage liver disease | CIRRHOSIS | To explore the potential mechanisms underlying the effects of a probiotic in cirrhotic patients, we analyzed the blood metabolome using proton nuclear magnetic resonance (In a previous double-blinded, placebo-controlled, randomized clinical trial, we observed that a multistrain probiotic improved cognitive function and... | PMC10079330 |
ACKNOWLEDGMENTS | The authors thank Carolyn Newey for English language revision. | PMC10079330 | ||
FUNDING INFORMATION | This study was partially funded by grant PI12/00629 from the Instituto de Salud Carlos III. Mendes S.A. (Lugano, Switzerland) also partially funded the study. | PMC10079330 | ||
CONFLICTS OF INTEREST | The authors have no conflicts to report.
Luca Laghi and Eva Román are co-first authors.Luca Laghi and German Soriano are co-corresponding authors.Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal’s, | PMC10079330 | ||
REFERENCES | PMC10079330 | |||
Background | caries | HYDROXYAPATITE, CARIES | Edited by: Dominic Augustine, M. S. Ramaiah University of Applied Sciences, IndiaReviewed by: Ralitsa Raycheva, Plovdiv Medical University, Bulgaria; Rodolfo Reda, Sapienza University of Rome, ItalyDental caries is a worldwide challenge for public health. The aim of this 18-month double-blinded, randomized, clinical tr... | PMC10393266 |
Methods | The primary endpoint was the percentage of subjects showing no increase in overall Decayed Missing Filled Surfaces (DMFS) index. The study was designed as non-inferiority trial. Non-inferiority was claimed if the upper limit of the exact one-sided 95% confidence interval for the difference of the primary endpoint DMFS ... | PMC10393266 | ||
Results | HYDROXYAPATITE | In total, 189 adults were included in the intention-to-treat (ITT) analysis; 171 subjects finished the study per protocol (PP). According to the PP analysis, no increase in DMFS index was observed in 89.3% of subjects of the hydroxyapatite group and 87.4% of the subjects of the fluoride group. The hydroxyapatite toothp... | PMC10393266 | |
Conclusion | Hydroxyapatite was proven to be a safe and efficient anticaries agent in oral care. | PMC10393266 | ||
Clinical trial registration | NCT04756557. | PMC10393266 | ||
1. Introduction | caries | CAVITY, HYDROXYAPATITE, CARIES | Hydroxyapatite, CaThe modes of action of hydroxyapatite in the oral cavity are based on physical, biochemical, and biological principles (The use of fluoride-free hydroxyapatite toothpastes has in recent years been shown to be a clinically proven approach to caries prevention (The efficacy of hydroxyapatite-based tooth... | PMC10393266 |
2. Materials and methods | PMC10393266 | |||
2.1. Objectives | caries | HYDROXYAPATITE, CARIES | The study objective was the investigation of the caries-preventing effect in adults aged 18–45 regularly using a fluoride-free, hydroxyapatite toothpaste (test toothpaste) or the fluoridated control toothpaste. The aim of the study was to compare the caries preventive effect of the test and control toothpaste to prove ... | PMC10393266 |
2.2. Study design | POLAND | The study was performed as a two-centered, double-blinded, randomized, and active-controlled parallel-group study with two arms (control and test). The study was performed at two study centers, i.e., Universities of Medical Sciences, Poznan and Bialystok, Poland. | PMC10393266 | |
2.3. Inclusion and exclusion criteria | Systemic disorders, allergy, caries, DMFS, tooth | SEVERE PERIODONTITIS, ALLERGY, CARIES | The following inclusion and exclusion criteria were applied:A) Inclusion criteria• Provision of written informed consent.• Age 18-45 years (both men and women).• A minimum of 10 caries-free (DMFS index=0) molars and premolars.• Willing to use an electric (powered) toothbrush.B) Exclusion criteria
• Untreated caries (su... | PMC10393266 |
2.4. Primary endpoint | Percentage of subjects showing no increase in overall Decayed Missing Filled Surfaces (DMFS) index (DMFS | PMC10393266 | ||
2.5. Secondary endpoints | PLAQUE, PLAQUE | A) Percentage of subjects experiencing no change in mineral density (as analyzed by laser diode near-infrared light transillumination of dental tissues with the use of DIAGNOcam) during the observation period of 18 months.B) Changes in the coverage of all teeth with bacterial plaque according to the criteria of the Pla... | PMC10393266 | |
2.6. Toothpastes (blinded) | HYDROXYAPATITE | The test toothpaste and the active control toothpaste were provided in neutral plastic tubes all having the same shape; thus, both the subjects and the investigators were blinded. It is pertinent to mention that the subjects were requested not to discuss anything related to the toothpastes with any of the study team me... | PMC10393266 | |
2.6.1. Test toothpaste—hydroxyapatite toothpaste (fluoride-free) | HYDROXYAPATITE | Aqua, hydrated silica, glycerin, hydrogenated starch hydrolysate, hydroxyapatite (10%), xylitol, silica, cellulose gum, sodium methyl cocoyl taurate, sodium sulfate, 1,2-hexanediol, aroma, caprylyl glycol, sodium cocoyl glycinate. | PMC10393266 | |
2.6.2. Active control toothpaste—fluoride toothpaste | HYDROXYAPATITE | Aqua, hydrated silica, glycerin, hydrogenated starch hydrolysate, xylitol, silica, cellulose gum, sodium methyl cocoyl taurate, sodium sulfate, 1,2-hexanediol, aroma, caprylyl glycol, sodium fluoride (1,450 ppm fluoride), sodium cocoyl glycinate.The composition of the hydroxyapatite test toothpaste was comparable to co... | PMC10393266 | |
2.7. Application | Tooth | Tooth brushing was performed twice a day (morning and evening; after the meals) for 3 min per episode. No other fluoride- and/or hydroxyapatite-containing oral care products, professional or home use, such as mouthwashes, gels, or fluoridate supplements, were allowed during the trial. | PMC10393266 | |
2.8. Toothbrushes | Electric (powered) toothbrushes (Oral-B; P&G, Schwalbach, Germany) were used by the subjects, and the brushing heads were changed every 2 months. | PMC10393266 | ||
2.9. Clinical examinations | carious lesion, caries, tooth | PLAQUE, CARIES, PLAQUE |
DMFS Index calculation (• When a carious lesion or both a carious lesion and a restoration were present, the surface was listed as a D.• When a tooth was extracted due to caries, it was listed as an M.• When a permanent filling was present, or when a filling was defective but not decayed, this surface was counted as a... | PMC10393266 |
2.10. Course of the study | caries, tooth | CARIES |
Potential subjects were informed by the investigator about the nature, significance, and scope of the clinical trial according to the requirements described in the written subject information. Before study enrollment, the willingness of the subjects to properly follow the study protocol throughout the 18 months of th... | PMC10393266 |
2.11. Methods of determining safety | ADVERSE EVENTS, CAVITY | Safety assessments were performed in all subjects at every visit. The clinical examiner visually examined each subject's oral cavity and perioral area as well as questioned the subjects on any adverse events. All observed or voluntarily reported adverse events (AEs) and serious adverse events (SAEs) regardless of the e... | PMC10393266 | |
2.12. Monitoring | RECRUITMENT | The monitor (Dr. Egmont Zieseniß, Inpharm Consulting, Germany) reviewed the case report forms with the investigator and his staff at regular intervals:First monitoring visit after 30% recruitment.Second monitoring visit after 12 months.Third monitoring visit at study close-out.During the study, the monitor reviewed the... | PMC10393266 | |
2.13. Determination of sample size and statistical analysis | caries lesions | REGRESSION, SECONDARY | It was assumed that the primary endpoint (i.e., no increase in DMFS index, i.e., ΔDMFS = Visit 4 - Visit 1 ≤ 0) will occur in about 60% of study subjects. A sample size of 77 study subjects per arm (two arms) was calculated to be sufficient to reject the null hypothesis that the test toothpaste is inferior to the contr... | PMC10393266 |
2.14. Ethical committee and study registration | POLAND | The study for both centers was approved by the ethical commission of the Poznan University of Medical Sciences, Poznan, Poland (No. 691/20; November 04, 2020). The study was registered at | PMC10393266 | |
3. Results | PMC10393266 | |||
3.1. Subjects | HYDROXYAPATITE | Overall, 194 subjects were included: 97 (50%) applied the hydroxyapatite toothpaste (test toothpaste) and 97 (50%) applied the fluoride toothpaste (control toothpaste) as randomized. The study was prematurely terminated in 20 (10.3%) subjects for several reasons (test toothpaste: All subjects who performed at least one... | PMC10393266 | |
3.2. Patient flowchart and analysis sets | The patient flow chart according to the CONSORT statement is shown in Patient flow chart.In the following, the results are reported for the PP population (“analyzed subjects”) if not mentioned otherwise. | PMC10393266 | ||
3.3. Demographic data | The demographic data of the PP population (Summary of the demographic data of the PP population.Age, weight, height, and sex did not differ significantly between groups (two-sided p-values > 0.10; t-test or chi-square test). | PMC10393266 | ||
3.4. Primary efficacy parameter—DMFS index | PMC10393266 | |||
3.4.2. Confirmative statistical test (primary analysis) and additional statistical tests | DMFS | REGRESSION | The primary efficacy endpoint was the percentage of subjects showing no increase in DMFS Index (ΔDMFS = DMFS Percentage of subjects without an increase of DMFS Index in the PP and ITT population.ΔDMFS%With ΔDMFS%ΔDMFS%The upper limit of the one-sided 95% confidence interval for the difference in percentage of subjects ... | PMC10393266 |
3.5. Secondary efficacy parameters | caries lesions | PLAQUE | Secondary efficacy parameters were (A) the overall number of caries lesions and (B) the coverage of all teeth with bacterial plaque according to the criteria of the PCR index ( | PMC10393266 |
3.5.2. NCL—explorative statistical tests | NCL, caries | REGRESSION, SECONDARY, CARIES | The secondary efficacy endpoint for NCL is the proportion of subjects showing no increase in NCL% (ΔNCL = NCL% ΔNCL%With ΔNCL%ΔNCL%Percentage of subjects without increase of NCL% (percentage of caries lesions) in the PP set.The upper limit of the one-sided 95% confidence interval for the difference in proportion of sub... | PMC10393266 |
3.5.4. PCR—explorative statistical tests | A two-sided Mann–Whitney–Wilcoxon test was applied (instead of | PMC10393266 | ||
3.6. Safety | All randomized subjects ( | PMC10393266 | ||
4. Discussion | caries lesions, caries, diet behaviors, tooth, NCL, orthodontic | SECONDARY, HYDROXYAPATITE, CARIES, DENTIN HYPERSENSITIVITY | In the present clinical trial, the effectiveness of hydroxyapatite toothpaste in preventing caries development was compared with that of fluoride (1,450 ppm) toothpaste, to determine the non-inferiority of the hydroxyapatite toothpaste to the fluoride toothpaste. Analysis of both the primary and the secondary outcome m... | PMC10393266 |
5. Conclusion | HYDROXYAPATITE | The results of this long-term double-blinded, randomized clinical trial in adults clearly show the non-inferiority of the fluoride-free hydroxyapatite toothpaste to the toothpaste with 1,450 ppm fluoride with regard to the primary endpoint DMFS index. According to the per-protocol analysis, no increase in DMFS index wa... | PMC10393266 | |
Data availability statement | The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s. | PMC10393266 | ||
Ethics statement | POLAND | The studies involving human participants were reviewed and approved by the Poznan University of Medical Sciences, Poznan, Poland (No. 691/20; November 4, 2020). The patients/participants provided their written informed consent to participate in this study. | PMC10393266 |
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