Efficacy of periodontal soft tissue augmentation prior to orthodontic treatment on preventing gingival recession: study protocol for a randomised controlled trial

Jing Chen; Jiashu Lv; Fan Zhang; Wei Zhang; Yuhui Wang; Yichen Xu; Yichen Pan; Qiang Li

doi:10.1136/bmjopen-2021-058942

Efficacy of periodontal soft tissue augmentation prior to orthodontic treatment on preventing gingival recession: study protocol for a randomised controlled trial

BMJ Open. 2022 Dec 13;12(12):e058942. doi: 10.1136/bmjopen-2021-058942.

Authors

Jing Chen^{1

2}, Jiashu Lv^{2

3}, Fan Zhang^{1

2}, Wei Zhang⁴, Yuhui Wang^{1

2}, Yichen Xu^{1

2}, Yichen Pan^{1

2}, Qiang Li^{5

3}

Affiliations

¹ Department of Orthodontics, Shanghai Stomatological Hospital, Fudan University, Shanghai, People's Republic of China.
² Shanghai Key Laboratory of Craniomaxillofacial Development and Diseases, Fudan University, Shanghai, People's Republic of China.
³ Department of Periodontics, Shanghai Stomatological Hospital, Fudan University, Shanghai, People's Republic of China.
⁴ Biomedical Informatics and Statistics Center, School of Public Health, Fudan University, Shanghai, Shanghai, China.
⁵ Department of Orthodontics, Shanghai Stomatological Hospital, Fudan University, Shanghai, People's Republic of China lqq401@sina.com.

Abstract

Introduction: In adult patients with thin phenotype, gingival recession is obvious in the mandibular incisors after a large amount of lingual tooth movement. A systematic review indicated that soft tissue augmentation before orthodontic treatment might yield satisfactory results with respect to the progression of gingival recession. However, the studies included had a low-to-moderate level of evidence. This study was designed to investigate the efficacy of soft tissue augmentation prior to orthodontic treatment on the prevention of gingival recession.

Method and analysis: This is a single-centre, single-blind, randomised controlled, double-armed parallel group comparison trial. This study was initiated in December 2021 and end in December 2025 (anticipated). Patients with mild crowding in the lower arch and a thin gingival type was enrolled and randomly assigned in a 1:1 ratio to either group A (having soft tissue augmentation prior to orthodontic treatment) or group B (having orthodontic treatment only). The planned number of enrolled patients was 48 (24 patients × 2 groups). The primary endpoint was the mean change in recession of the gingival margin. Secondary endpoints included the probing depth, gingival phenotype, frequency of complete root coverage, gingival thickness, width of the keratinised gingiva, clinical attachment level, gingival recession class, full-mouth plaque score, alveolar bone thickness in the faciolingual dimension of the lower anterior teeth and lower incisor inclination.

Ethics and dissemination: The study protocol was approved by the Ethical Committee of the Shanghai Stomatological Hospital (certificate number (2021)016). The study was conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act and other current legal regulations in China. Written informed consent was obtained from all the participants. The results of this study will be reported in journal publications.

Trial registration number: ChiCTR2100050892.

Keywords: HEALTH ECONOMICS; ORAL & MAXILLOFACIAL SURGERY; ORAL MEDICINE.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

China
Gingiva
Gingival Recession* / prevention & control
Humans
Incisor
Randomized Controlled Trials as Topic
Single-Blind Method