Effectiveness of Bionator functional orthodontic appliance in the treatment of Class II malocclusion in children: a systematic review and meta-analysis

Background: Malocclusion is a variation in the teeth association between the dental arches above the accepted limits of normal ranges. This meta-analysis was conducted to appraise the Bionator functional appliance’s treatment efficiency on children’s malocclusion. Methods: Four electronic databases, including Google Scholar and PubMed, were searched up to September 2023. The lists of references used in other meta-analyses and systematic reviews were manually searched to look for other trials not found during the first search. Only prospective controlled clinical trials and randomized clinical trials analyzing the treatment efficacy of the Bionator in correcting malocclusion in children were included in the data collection. Two authors then independently did the study selection, assessment of the risk of bias, and data extraction. Pooled data analysis was then carried out using the random effects model. Results: 7 articles in total were included, and the trials collected data from a total of 431 children’s patients. The mean differences (MDs) in overall treatment effects of the Bionator in relation to the untreated control groups were: 0.10◦ (95% confidence intervals (CI) (−0.25◦, 0.45◦)) in sella-nasion-subspinale (SNA) angle change, 1.17◦ (95% CI, (0.64◦, 1.70◦)) in sella-nasion-supramental (SNB) angle change, and −1.15◦ (95% CI, (−1.42◦, −0.88◦)) in subspinale-nasion-supramental (ANB) angle change. The Bionator functional appliance, according to the analysis, did not have any crucial effect on the SNA angle when likened to the control group for a short term. Additionally, the Bionator did not significantly affect the SNB angel compared to the controls. However, the Bionator resulted in a reduction in ANB angle, indicating that it improved the Class II malocclusion skeletal jaw relationships. Conclusions: The Bionator is inferior to the Twin Block in the treatment of Class II malocclusion. The PROSPERO Registration: The protocol is registered in Prospective Register of Systematic Reviews (PROSPERO) registration number CRD42023468142.

Orthodontics; Angle Class II malocclusion; Pediatric dentistry; Orthodontic appliance; Bionator

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