Effectiveness of acellular dermal matrix graft with a coronally advanced flap for the treatment of Miller Class I/II single gingival recession with thin gingival phenotype: study protocol for a split-mouth randomised controlled trial

INTRODUCTION: Gingival recession is one of the most common mucogingival deformities requiring surgical correction. The American Academy of Periodontology Regeneration Workshop recommended connective tissue graft (CTG) combined with coronally advanced flap (CAF) for the treatment of Miller Class I and II single-tooth gingival recession. The disadvantages of harvesting autogenous tissue include postoperative bleeding, pain and discomfort at the donor site, restricted tissue supply, increased morbidity and prolonged operative times. Acellular dermal matrix (ADM) contains undamaged collagen and elastin matrices that can be used as a substitute for CTG during root coverage procedures. However, the use of ADM is still controversial. The objective of this split-mouth; randomised, controlled, clinical study is to evaluate the long-term effects of ADM graft (ADMG) combined with CAF on root coverage, aesthetics and patient satisfaction for the treatment of single gingival recession with thin gingival phenotype. METHODS AND ANALYSIS: Forty participants with bilateral Miller Class I/II gingival recession will be randomised to receive an ADMG on one side and CTG on the contralateral side, combined with CAF. Gingival recession depth, gingival recession width and keratinised tissue width will be measured at baseline, 2 weeks and 1, 3, 6, 12 and 24 months. Mean root coverage, complete root coverage, root coverage aesthetic score, colour change (∆E) and patient satisfaction will be assessed during follow-up visits. ETHICS AND DISSEMINATION: The present study has received approval from the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-202054029). Data of this study will be registered with the International Clinical Trials Registry Platform. Additionally, we will disseminate the results through scientific journal. TRIAL REGISTRATION NUMBER: ChiCTR2000033230.