Evidence shows that the quality of reporting of randomised controlled trials (RCTs) is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings and researchers from extracting information for systematic reviews and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of RCTs. Within person trials are used for conditions that can affect two or more body sites, and are a useful and efficient tool because the comparisons between interventions are within people. Such trials are most commonly conducted in ophthalmology, dentistry, and dermatology. The reporting of within person trials has, however, been variable and incomplete, hindering their use in clinical decision making and by future researchers. This document presents the CONSORT extension to within person trials. It aims to facilitate the reporting of these trials. It extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence based rationale for CONSORT within person checklist items are provided.
The purpose of this study was to evaluate the periodontal tissues of patients with mandibular fixed retention for long or short periods of time. A total of 64 individuals were selected for this study using the following inclusion criteria: long-term lingual fixed retention; identical type of lingual fixed retainer bonded with the same materials; no cavities, restorations, or fractures of the mandibular anterior teeth; absence of habits and occlusal interferences; and canine guidance bilaterally. The resultant sample comprised 32 patients (mean age 25 years) who had been in retention for a mean period of 9.65 years (range 9-11 years) and an equal number retained for a period between 3 and 6 months. Plaque, gingival, and calculus indices, probing pocket depth, marginal recession, and bone level at the mandibular six anterior teeth were recorded for both groups. Demographic, clinical, and radiographic data were investigated with conventional descriptive statistics. Comparisons of the different variables between the two participant groups (long- and short-term retention) were carried out using a Mann-Whitney test for indices (plaque, gingival, and calculus), and a Fisher's exact test (two sided) for the remaining variables. No significant difference was found with respect to the plaque and gingival indices and bone level between the two groups. The long-term group presented higher calculus accumulation, greater marginal recession, and increased probing depth (P < 0.05). The results of this study raise the question of the appropriateness of lingual fixed retainers as a standard retention plan for all patients regardless of their attitude to dental hygiene. They also emphasize the importance of individual variability and cautious application of retention protocols after a thorough consideration of issues related to the anatomy of tissues and oral hygiene.
Based on prospective studies carried out in university settings, comprehensive orthodontic treatment on average requires less than 2 years to complete.
The objective of this study was to investigate the effect of bracket type (conventional and self-ligating) on the levels of Streptococcus mutans and total bacterial counts in whole saliva of orthodontic patients. Thirty-two male and female patients were selected using the following inclusion criteria: adolescents (mean age 13.6 years, range 11-17 years), fixed appliances in both arches, non-smoker, and no reported oral habits. Demographic and oral hygiene characteristics were determined for each subject. The patients were subdivided into two groups with random allocation of bracket type (conventional or self-ligating). An initial saliva sample was obtained before the initiation of treatment (T1) and a second sample 2-3 months following appliance bonding (T2). Salivary S. mutans and total bacteria were enumerated and analysed after growth in culture. The demographic and clinical characteristics of the samples were analysed with a t- or chi-square test, where applicable, to assess the random allocation of bracket group to participants. The results of S. mutans and total facultative bacterial counts were log transformed and statistically analysed with analysis of covariance with bracket (conventional versus self-ligating) as the categorical variable and initial total bacterial counts or initial S. mutans levels serving as the covariate. No difference was found in the demographics and oral hygiene indices between the two groups, verifying the random assignment of brackets to the population sample. The levels of S. mutans in whole saliva of orthodontically treated patients do not seem to be significantly different between conventional and self-ligating brackets. The pre-treatment levels of S. mutans are significant predictors of the levels of S. mutans after placement of orthodontic appliances, while this was not the case for total bacterial counts.
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