Effect of porcine collagen matrix versus rotated pedicle palatal connective tissue flap on the soft-tissue closure after the immediate posterior implantation: study protocol for a randomised controlled trial.

INTRODUCTION

Soft-tissue defect is commonly seen in immediate maxillary posterior implantation because of tooth extraction wound and tension from bone graft. Bone graft materials exposure has a significant detrimental influence on bone augmentation. However, previous studies lack sufficient evidence to guide wound closure after immediate posterior implantation. This study aims to use 3D integration technology to evaluate the effect of porcine collagen matrix versus rotated pedicle palatal connective tissue flap (RPPCTF) on the soft-tissue closure after the immediate maxillary posterior implantation.

METHODS AND ANALYSIS

This is a single-centre, evaluator-blinded, randomised, two-arm parallel-group controlled trial. A total of 54 patients requiring immediate implant placement in the first upper molar extraction sockets will be recruited. The patients will be randomly assigned to two groups: one group will receive the porcine collagen matrix and the other group will receive RPPCTF on the soft-tissue closure after the immediate posterior implantation. The primary outcome is the soft-tissue volume change. Secondary outcomes include width of keratinised gingiva, healing status of soft tissue, marginal bone level and operation time.

ETHICS AND DISSEMINATION

The study protocol has been approved by the Ethics Committee of Shanghai Stomatological Hospital (SHSHIRB-2022016). The project has been registered on the ClinicalTrials.gov website and National Medical Research Registration and Filing Information System. Written informed consent was obtained from all the participants. The results of this study will be reported in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ChiCTR2300067770.