Does observational study on the effectiveness of the Twin Blocks overestimate or underestimate the results? A comparative analysis of retrospective samples versus randomized controlled trial.

BACKGROUND AND OBJECTIVES: Class II malocclusion is one of the most common orthodontic problems. The Twin Block appliance has proven to be the most popular appliance for the correction of these malocclusions. Although randomized controlled trials (RCTs) on the Twin Block appliance have reported the changes to be mainly dentoalveolar, several nonrandomized studies have reported a significant skeletal improvement in these patients. Hence, the aim of this study was to compare the effectiveness of Twin Block appliance evaluated using an RCT or retrospectively selected cases (RSC) for the treatment of Class II Division 1 malocclusion in an adolescent population. METHODS: This was a retrospective study. The results for an RCT were selected from a UK Class II multicenter study. Sixty-three patients from the trial were included. This group was matched with retrospectively selected Class II cases treated with a Twin Block functional appliance and their results submitted for Membership in Orthodontics examination in the United Kingdom, from four centers. The primary outcome was skeletal measurement ANB (A point, nasion, B point). Secondary outcomes included final peer assessment rating (PAR) scores and final overjet. Intrarater reliability of measurements was assessed. Independent samples t-test was carried out to look at the difference between the groups. RESULTS: The reliability assessment showed excellent agreement for all measurements. The data were normally distributed. There was a statistically significant difference favoring the RSC group for final overjet (mean difference [MD] = 1.068, 95% confidence interval [CI] -0.67 to 1.47, P = 0.000) and final PAR (MD = 4.0, 95% CI -0.79 to 5.5, P = 0.000). There was no significant difference in the scores for final ANB (MD = 0.34, 95% CI -0.39 to 1.07, P = 0.33). CONCLUSION: The RSCs show significantly improved overjet and PAR scores at the end of treatment and no statistically significant difference for skeletal change. The study raises the question of a potential role of observational studies in evaluating the effect of an intervention in orthodontics.