Randomized clinical trials of dental bleaching – Compliance with the CONSORT Statement: a systematic review

Abstract

We reviewed the literature to evaluate: a) The compliance of randomized clinical trials (RCTs) on bleaching with the CONSORT; and b) the risk of bias of these studies using the Cochrane Collaboration risk of bias tool (CCRT). We searched the Cochrane Library, PubMed and other electronic databases, to find RCTs focused on bleaching (or whitening). The articles were evaluated in compliance with CONSORT in a scale: 0 = no description, 1 = poor description and 2 = adequate description. Descriptive analyses of the number of studies by journal, follow-up period, country and quality assessments were performed with CCRT for assessing risk of bias in RCTs. 185 RCTs were included for assessment. More than 30% of the studies received score 0 or 1. Protocol, flow chart, allocation concealment and sample size were more critical items, as 80% of the studies scored 0. The overall CONSORT score for the included studies was 16.7 ± 5.4 points, which represents 52.2% of the maximum CONSORT score. A significant difference among journal, country and period of time was observed (p < 0.02). Only 7.6% of the studies were judged at "low" risk; 62.1% were classified as "unclear"; and 30.3% as "high" risk of bias. The adherence of RCTs evaluating bleaching materials and techniques to the CONSORT is still low with unclear/high risk of bias.

Pharmacological Control of Complications Following to Third Molar Removal: Evidence Based on A Meta-Analysis

“…Randomized clinical trials are considered the gold research method for the assessment of health treatments or interventions [23]. In this regard, a systematic review by Loguercio et al demonstrated that only few clinical studies published are quality reports according to international quality guidelines, e. g.: Consolidate Standard Of Randomized Trials (CONSORT) Statement [24]. The CONSORT guideline tries to standardize the writing and publication of clinical trials through the description of specific items in this kind of reports.…”

Does the Use of Reservoirs Have Any Impact on the Efficacy of At-Home Bleaching? A Systematic Review

“…Apart from the above limitations, which are not much different from what has already been observed in bleaching studies in general (27), the most shocking finding was the lack of standardized methods for reporting important outcomes in bleaching studies, such as color change, risk of tooth sensitivity, and gingival irritation. This fact along with lack of examiner blinding reduces consistently the reliability of the study findings of the eligible studies.…”

“…From the findings of the present study, we concluded that there is no reliable evidence to make any conclusion about the efficacy and side effects of bleaching trays with reservoirs compared to bleaching trays without reservoirs, due to the lack of well-designed clinical studies on this subject. Further well-designed randomized clinical trials with good reporting should be performed by carefully following the Consolidate Standards of Reporting Trials (CONSORT) (27,33).…”

Reference is not evidence

“…15 Prospective registration 17 and compliance to the CONSORT statement are also subotpimal. 13,18 Other more general aspects also threaten studies' validity, such as conflicts of interest. Even financial conflicts of interest, which are the easiest to identify, have been poorly reported in dentistry.…”