scholarly journals Selective Outcome Reporting (SOR) in Pediatric Dentistry restorative treatment randomized clinical trials - A meta-research.

2021 ◽  
Author(s):  
Rokaia Ahmed Elagami ◽  
Tamara Kerber Tedesco ◽  
Claudio Mendes Pannuti ◽  
Gabriela Seabra da Silva ◽  
Mariana Minatel Braga ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Teeth ◽  
Randomized Clinical Trials ◽  
Scientific Journal ◽  
Pediatric Dentistry ◽  
World Health ◽  
Selective Outcome Reporting ◽  
Restorative Treatment ◽  
Outcome Reporting

Abstract BackgroundSelective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a randomized clinical trial (RCT) is omitted or changed prospectively. We evaluated the prevalence of SOR in RCTs on restorative caries treatment in primary teeth.MethodsWe conducted an electronic search on ClinicalTrials.gov and the World Health Organization (WHO) platform up to April/2021. We included RCT protocols that tested restorative treatments in primary teeth and excluded any protocol that has not resulted in at least one publication in a peer-reviewed scientific journal. The Chi-square test was used to detect the association between SOR and other variables (α = 5%).ResultsOut of 294 potential protocols, thirty were included. We found 34 corresponding publications and had the one that seemed to report the primary outcome and longest follow-up, resulting in 30 publications. SOR was observed in 53.3% (n=16) of the published trials and was significantly associated with the discrepancy in the follow-up period (p=0.017).ConclusionThere is a considerable prevalence of selective outcome reporting (SOR) on restorative trials in primary teeth. Properly pre-registered protocols and assessing them for the peer review processes will help decrease SOR.Practical implicationsRestorative treatment trials in primary teeth that selectively modify outcomes of interest have been shown to distort the treatment effect. Practitioners should avoid using restorative treatments based on misleading results in clinical practice.

Selective outcome reporting in root coverage randomized clinical trials

2021 ◽  
Author(s):  
Daniel Isaac Sendyk ◽  
Nathalia Vilela Souza ◽  
João Batista César Neto ◽  
Dimitris N. Tatakis ◽  
Cláudio Mendes Pannuti
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Root Coverage ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

scholarly journals Restoration of Primary Anterior Teeth with Glass Fiber-Reinforced Post and Core: 3-Year Follow-Up Case Report

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Salah Afraa ◽  
Hashim Raghad ◽  
Khalid Ayam ◽  
Hamid Aeshah
Keyword(s):  
Glass Fiber ◽  
Primary Teeth ◽  
Pediatric Dentistry ◽  
Endodontic Treatment ◽  
Fiber Reinforced ◽  
Anterior Teeth ◽  
Glass Fiber Reinforced ◽  
Post And Core ◽  
Maxillary Incisors

Background. Esthetic appearance of primary anterior teeth is one of the major demands in the dental field. Destructed anterior primary teeth due to caries is considered a major issue due to the difficulty in regaining the esthetic crowns and attaching them until the normal exfoliation time. There have been many attempts and tools used to attach the composite crowns to the treated canals of primary anterior teeth. The study evaluates endodontic treatment for destructed primary maxillary incisors with a glass fiber-reinforced post as a retentive tool to hold the esthetic composite crowns until the normal exfoliation time of primary incisors. Case Presentation. A four-year-old child attending a dental clinic complained of pain of maxillary incisors. Dental examination showed irreversible pulpitis of four maxillary incisors indicated for root canal treatment and crown placement. Endodontic treatment was carried out, and a glass fiber-reinforced post was used to get successful retention for the composite crowns. Follow-up was carried out for 3 years. The 3 crowns were retained successfully until replaced by permanent incisors. One crown fell during the treatment course. Conclusion. Retention of primary teeth is one of the challenges in pediatric dentistry. Restoration of primary decayed incisors is important for child medical, physical, and psychological conditions. A glass fiber-reinforced post and core is a strong retentive tool for composite crown retention for primary incisors. This procedure opens the door for a strong tool to retain composite crowns for a long time. The glass fiber-reinforced post and core is a strong retentive tool for composite crown retention for primary incisors.

Effect of Papacarie and Alternative Restorative Treatment on Pain Reaction during Caries Removal among Children: A Randomized Controlled Clinical Trial

2017 ◽  
Vol 41 (3) ◽  
pp. 219-224 ◽  
Author(s):  
AMG Abdul Khalek ◽  
MA Elkateb ◽  
WE Abdel Aziz ◽  
M El Tantawi
Keyword(s):  
Clinical Trial ◽  
Primary Teeth ◽  
Pediatric Dentistry ◽  
Controlled Clinical Trial ◽  
Kappa Statistics ◽  
Atraumatic Restorative Treatment ◽  
Public Health Department ◽  
Restorative Treatment ◽  
Randomized Controlled ◽  
Caries Removal

Objective: To compare the effect of Papacarie and Atraumatic Restorative Treatment (ART) on pain and discomfort during caries removal among children. Study Design: Fifty healthy, 4–8 year-old children were equally and randomly allocated to Papacarie and ART to remove caries from decayed primary teeth. A randomized, controlled, blinded, two parallel-arms clinical trial was conducted in the clinic of the Pediatric Dentistry and Dental Public Health Department, Alexandria University, Egypt in March 2014. Pain and discomfort were assessed blindly by two independent investigators watching videotaped treatment sessions using the Sound, Eye and Motor scale (SEM). Their reliability was assessed using Kappa statistics. The effect of caries removal methods, time spent to remove caries and other confounders on SEM score was assessed using regression analysis. Results: Mean time to remove caries using Papacarie and ART was 5.8 and 4.8 minutes, P= 0.005. Median Paparie and ART scores for the S, E and M components were 1, 1, 1 and 3, 2, 3. Adjusted mean SEM score= 3.6 and 7.8, P <0.0001. Method of caries removal was the only factor significantly affecting pain and discomfort. Conclusion: Papacarie is associated with minimal pain during caries removal from primary teeth compared to ART, although it has longer working time.

Restorative Treatment on Class I and II Restorations in Primary Molars: A Survey of Brazilian Dental Schools

2006 ◽  
Vol 30 (2) ◽  
pp. 175-178 ◽  
Author(s):  
Cristiane Motisuki ◽  
Luciana Monti Lima ◽  
Lourdes dos Santos-Pinto ◽  
Márcio Guelmann
Keyword(s):  
Primary Teeth ◽  
Response Rate ◽  
Pediatric Dentistry ◽  
Class I ◽  
Primary Molars ◽  
Restorative Treatment ◽  
Restorative Materials ◽  
Dental Schools

A survey was sent to 70 Brazilian dental schools evaluating techniques and restorative materials being taught for Class I and II preparation in posterior primary teeth by Pediatric Dentistry courses. After a 54% response rate, marked teaching diversity was found among Brazilian dental schools. Amalgam continues to be taught, but a tendency of preference towards more esthetic-like materials was observed.

scholarly journals Management of late dental trauma healing complications in primary teeth: a case report of 3 years follow-up

2016 ◽  
Vol 73 (3) ◽  
pp. 253
Author(s):  
Nashalie Andrade de Alencar ◽  
Tatiana Kelly da Silva Fidalgo ◽  
Jacckeline Barros ◽  
Maria da Encarnação P. Requejo da Costa ◽  
Lucianne Cople Maia
Keyword(s):  
Case Report ◽  
Primary Teeth ◽  
Case Reports ◽  
Traumatic Injury ◽  
Dental Trauma ◽  
Pediatric Dentistry ◽  
Permanent Tooth ◽  
Maxillary Central Incisor ◽  
Main Complaint

Objective: This case reports the management of late healing complications in primary teeth after dental trauma. Case Report: A 6-year-old girl was referred to the pediatric dentistry clinic with a huge swelling associated with her anterior maxillary left-side region as a main complaint. Her mother reported a traumatic injury in the affected tooth one year before. The clinical exam revealed a noncomplicated fracture and an extensive abscess, both radiographically associated with the left maxillary central incisor. Additionally, pulp obliteration in its homologous tooth was observed. The abscessed tooth was extracted and the homologous tooth was maintained, the child was followed up for three years. No crown or root pathological alterations were observed in either erupted permanent successors. Conclusion: Traumatic injury in the primary teeth may show no initial healing complication however, the follow up and treatment of acute healing complications is essential until the eruption of the permanent tooth.

scholarly journals Primary outcome reporting in adolescent depression clinical trials needs standardization

2020 ◽  
Author(s):  
Andrea Monsour ◽  
Emma J. Mew ◽  
Sagar Patel ◽  
Alyssandra Chee-a-tow ◽  
Leena Saeed ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Outcome Assessment ◽  
Adolescent Depression ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
Outcome Reporting ◽  
Meta Analyses

Abstract Background: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as “fully reported”, “partially reported”, or “not reported” for each checklist item, as applicable. Results: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6-17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. Conclusions: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed. Trial registration: Not applicable

scholarly journals Study Protocol: Optimization of the surgical and medical management of diabetic foot infections

2019 ◽  
Author(s):  
Felix WA Waibel ◽  
Martin Berli ◽  
Sabrina Catanzaro ◽  
Kati Sairanen ◽  
Madlaina Schöni ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Antibiotic Therapy ◽  
Diabetic Foot ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Antibiotic Use ◽  
Wound Debridement ◽  
Diabetic Foot Infections ◽  
Systemic Antibiotic Therapy

Abstract Background: Few studies address the appropriate duration of antibiotic therapy for diabetic foot infections (DFI); with or without amputation. We perform two randomized clinical trials (RCT) to reduce the antibiotic use and associated adverse events in DFI. Methods: We hypothesize that shorter durations of post-debridement systemic antibiotic therapy are non-inferior (10% margin, 80% power, ɑ 5%) to existing (long) durations and perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCT is “remission of infection” after a minimal follow-up of two months. The 1 st RCT allocates the amputations in two arms of 50 patients each: 1 vs. 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 vs. 4 days for remaining soft tissue infection. The 2 nd RCT randomizes the conservative approach in two arms with 50 patients each: 10 vs. 20 days of antibiotic therapy for soft tissue infections; and 3 vs. 6 weeks for osteomyelitis. All participants have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, internist and infectiology care. During the surgeries, we collect tissues for BioBanking and future laboratory studies. Discussion: Both parellel RCT will enable to prescribe less antibiotics for DFI; for a conservative therapy and after amputation. Trial registration: ClinicalTrial.gov NCT04081792. Registered on 4 th September 2019. Protocol version : 2 (15 th July 2019)

Human enamel veneer restoration: an alternative technique to restore anterior primary teeth

2006 ◽  
Vol 30 (4) ◽  
pp. 277-279
Author(s):  
Luciana Butini Oliveira ◽  
Tereza Keiko Tamay ◽  
Marta Dutra Machado Oliveira ◽  
Célia Regina Martins Delgado Rodrigues ◽  
Marcia Turolla Wanderley
Keyword(s):  
Primary Teeth ◽  
Dental Treatment ◽  
Resin Composite ◽  
Treatment Options ◽  
Dental Enamel ◽  
Pediatric Dentistry ◽  
Restorative Treatment ◽  
Anterior Teeth ◽  
Human Enamel ◽  
Space Maintainer

Restoration of severely decayed primary teeth is a clinical challenge in Pediatric Dentistry. Among the restorative treatment options, the use of prefabricated crowns and resin composite restorations, either by means of direct or indirect techniques is mentioned in the literature. The purpose of this article is to describe the rehabilitation of primary anterior teeth in a 5-year-old patient. Dental treatment consisted on an anterior space maintainer prosthesis made with natural primary teeth, plus human dental enamel veneer (facet) restorations. The advantages of this technique are better esthetics and the natural enamel has physiologic wear and offers superficial smoothness and cervical adaptation compatible with those of the surrounding teeth.

scholarly journals Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028694
Author(s):  
Christopher W Jones ◽  
Amanda Adams ◽  
Mark A Weaver ◽  
Sara Schroter ◽  
Benjamin S Misemer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Peer Review ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Selective Outcome Reporting ◽  
Outcome Reporting ◽  
Cluster Randomised ◽  
Peer Reviewers

IntroductionClinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.Methods and analysisPRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study’s trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.Ethics and disseminationThe Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.Trial registration numberISRCTN41225307; Pre-results.

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