Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial.

introductionClass II treatment with mandibular retrusion often involves the Herbst appliance due to its efficiency and low requirement of cooperation. Despite its advantages, it causes side effects concerning the occlusal plane and pogonion in terms of clockwise rotation that hinder the desired mandibular advancement for hyperdivergent patients. In this study, we will use a newly designed Herbst appliance, and a protocol that is accompanied by TADs for vertical control to avoid maxillary clockwise rotation. We hypothesise that the effect of the Herbst appliance with the vertical control approach will be beneficial for maintaining or even decreasing the skeletal divergence in hyperdivergent class II patients compared with conventional Herbst treatment. METHODS AND ANALYSIS: This study is a randomised, parallel, prospective controlled trial that will study the efficacy of Herbst with or without vertical control in children with hyperdivergent skeletal class II malocclusion. A total of 44 patients will be enrolled and randomised in a ratio of 1:1 to either Herbst treatment or Herbst treatment with vertical control. Participants will be recruited at the Shanghai Stomatological Hospital, Shanghai, China. The primary endpoint is the change in the angle indicating the occlusal plane and Sella-Nasion plane from baseline (T0) to the primary endpoint (T2) on cephalometric measurements by lateral X-ray examination. Important secondary outcomes include the root length of the anterior teeth, and the assessment score of the Visual Analogue Scale Questionnaire, etc. Safety endpoints will also be evaluated. ETHICS AND DISSEMINATION: This study has been approved by the ethics committee of the Shanghai Stomatological Hospital (Approval No. (2021) 012). Before enrolment, a qualified clinical research assistant will obtain written informed consent from both the participants and their guardians after full explanation of this study. The results will be presented at national or international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2100049860, Chinese Clinical Trial Registry.