Selective outcome reporting in paediatric dentistry restorative treatment randomised clinical trials-A meta-research.

BACKGROUND: Selective outcome reporting (SOR) is a bias that occurs when the primary outcome of a randomised clinical trial (RCT) is omitted or changed. AIM: To evaluate the prevalence of SOR in RCTs on restorative treatment in primary teeth. DESIGN: We conducted an electronic search on ClinicalTrials.gov and the World Health Organization platform (International Clinical Trials Registry Platform) on 1st of April 2021, with no registry time or language restrictions. We included RCT protocols that evaluated restorative treatments in primary teeth and excluded trials that did not have a complete publication in a scientific journal. The chi-squared test was used to identify the association between SOR and variables as a discrepancy in the follow-up period, the timing of registration, the type of sponsorship and the type of study design (α = 5%). RESULTS: Of the 294 identified protocols, 30 were included in the study. 83.3% of trials were registered retrospectively. SOR was observed in 53.3% (n = 16) of the published trials and was significantly associated with a discrepancy in the follow-up period (p = .017). CONCLUSIONS: The high prevalence of SOR in RCTs on restorative treatment proves that this is a prominent threat. A proper preregistered protocol, declaration of any protocol deviation and allowance of stakeholders to compare the protocol with that of the submitted papers will achieve transparency.

Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial.

BACKGROUND: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems. METHODS: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's - behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's - satisfaction and anxiety; (C) family and child - impact on oral health-related quality of life (OHRQoL); (D) dentist's - satisfaction and stress; (E) procedure - adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS). DISCUSSION: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180.

Periodontal Changes After Caries Management in Preschool and School-Age Children.

Purpose: To evaluate the effect of caries management on the periodontal status of preschool and school-age children.
Methods: Twenty-six four- to eight-year-old children with at least one primary molar with a deep carious lesion were selected to undergo a periodontal evaluation before and six months after dental treatment. Two examiners conducted the periodontal exams using the visible plaque index (VPI) and gingival bleeding index (GBI). Longitudinal changes were compared using paired t-test and Fisher's test. Poisson regression models were used to investigate the variables influencing GBI (α =five percent).
Results: There were no significant differences in the mean percentage of VPI-positive sites (55.8±26.9 percent to 54.5±29.8 percent; P =0.829) and GBI-positive sites (37.2±22.2 percent to 32.1±22.8 percent; P =0.222) before and after treatment. In contrast, the mean number of GBI sites decreased from 8.5±5.03 to 6.3±4.39 (P =0.026), while the percentage of patients presenting GBI of no more than 10 percent increased from 11.5 percent to 26.9 percent over time (P =0.013). Similar analyses for VPI did not show a statistical significance. Boys (P =0.037) and six- to eight-year-old children ( P =0.029) had lower reductions on GBI.
Conclusion: Caries management has a positive impact on the periodontal condition of children, especially on gingival bleeding.

Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) - study protocol for a noninferiority randomized clinical trial.

BACKGROUND: Due to the lack of evidence to determine the best treatment for deep cavitated caries lesions in primary molars, the search for an effective restorative technique, which results in a minimal discomfort to patients, and reduce the time needed for the treatment, becomes relevant. The objective of this randomized clinical trial was to evaluate if high-viscosity glass ionomer cement (HVGIC) restorations is noninferior to restoration with calcium hydroxide cement associated with HVGIC for treatment of deep lesions in primary molars, as well as the impact of the treatments on cost and discomfort of the patient. METHODS: A non-inferiority randomized clinical trial with two parallels arms (1:1) will be conducted. Children with 4 to 8 years will be selected at Clinic of Pediatric Dentistry at Ibirapuera University. 108 teeth will be randomized into two groups: (1) Calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. Primary outcome will be considered the pulp vitality and to be evaluated after 6, 12, 18 and 24 months by two calibrated examiners. Survival of restorations will also be evaluated in the equal intervals. The duration of dentals treatment and the cost of all materials used will be considered for estimating of cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Wong-Baker's Facial Scale. For the primary outcome, Kaplan-Meier survival and the long-rank test will be used to comparison between the groups. Cox regression will be performed to assess the influence of variables on the outcome. For all analyzes, the significance level is set at 5%. DISCUSSION: Based on the philosophy of ART, our hypothesis is that the HVGIC restoration is a possible approach to restore the deep caries lesion with pulp vitality without the use of rubber dam and anesthesia. TRIAL REGISTRATION: Clinicaltrials.gov registration NCT02903979 . Registered on June 9th 2016.