Cargando…

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

INTRODUCTION: Class 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 ma...

Descripción completa

Detalles Bibliográficos
Autores principales: Wang, Yuhui, Xu, Yichen, Gong, Zhicheng, Pan, Jie, Liu, Yuehua
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10450085/
https://www.ncbi.nlm.nih.gov/pubmed/37620276
http://dx.doi.org/10.1136/bmjopen-2023-071840
_version_ 1785095119731425280
author Wang, Yuhui
Xu, Yichen
Gong, Zhicheng
Pan, Jie
Liu, Yuehua
author_facet Wang, Yuhui
Xu, Yichen
Gong, Zhicheng
Pan, Jie
Liu, Yuehua
author_sort Wang, Yuhui
collection PubMed
description INTRODUCTION: Class 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
format Online
Article
Text
id pubmed-10450085
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-104500852023-08-26 Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial Wang, Yuhui Xu, Yichen Gong, Zhicheng Pan, Jie Liu, Yuehua BMJ Open Dentistry and Oral Medicine INTRODUCTION: Class 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 BMJ Publishing Group 2023-08-24 /pmc/articles/PMC10450085/ /pubmed/37620276 http://dx.doi.org/10.1136/bmjopen-2023-071840 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Dentistry and Oral Medicine
Wang, Yuhui
Xu, Yichen
Gong, Zhicheng
Pan, Jie
Liu, Yuehua
Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial
title Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial
title_full Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial
title_fullStr Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial
title_full_unstemmed Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial
title_short Efficacy of an innovative Herbst appliance with TADs for patients with hyperdivergent class II malocclusion: study protocol for a randomised controlled trial
title_sort efficacy of an innovative herbst appliance with tads for patients with hyperdivergent class ii malocclusion: study protocol for a randomised controlled trial
topic Dentistry and Oral Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10450085/
https://www.ncbi.nlm.nih.gov/pubmed/37620276
http://dx.doi.org/10.1136/bmjopen-2023-071840
work_keys_str_mv AT wangyuhui efficacyofaninnovativeherbstappliancewithtadsforpatientswithhyperdivergentclassiimalocclusionstudyprotocolforarandomisedcontrolledtrial
AT xuyichen efficacyofaninnovativeherbstappliancewithtadsforpatientswithhyperdivergentclassiimalocclusionstudyprotocolforarandomisedcontrolledtrial
AT gongzhicheng efficacyofaninnovativeherbstappliancewithtadsforpatientswithhyperdivergentclassiimalocclusionstudyprotocolforarandomisedcontrolledtrial
AT panjie efficacyofaninnovativeherbstappliancewithtadsforpatientswithhyperdivergentclassiimalocclusionstudyprotocolforarandomisedcontrolledtrial
AT liuyuehua efficacyofaninnovativeherbstappliancewithtadsforpatientswithhyperdivergentclassiimalocclusionstudyprotocolforarandomisedcontrolledtrial