Efficacy of periodontal therapy in preventing tooth loss and improving masticatory function in patients with chronic kidney disease: a protocol for a single-centre randomised controlled trial in China.

INTRODUCTION

Periodontitis and chronic kidney disease (CKD) are inter-related conditions that can significantly impact patient health. This study aims to evaluate the efficacy of active non-surgical periodontal therapy (NSPT) combined with supportive periodontal care (SPC) in reducing tooth loss and improving masticatory function in patients with CKD and stage III periodontitis.

METHODS AND ANALYSIS: This randomised controlled trial will recruit 86 patients diagnosed with both stage III periodontitis and CKD. Participants will be randomly assigned at a 1:1 ratio to either an experimental group receiving active NSPT supplemented with SPC or a control group receiving oral hygiene instruction with scheduled periodontal monitoring. The intervention will last for 24 months, with assessments conducted at baseline and 3, 6, 12, 18 and 24 months. The primary outcome is the incidence of tooth loss due to periodontitis over the 2-year follow-up period. Secondary outcomes include the number of lost teeth, masticatory function, clinical periodontal parameters and oral health-related quality of life.

ETHICS AND DISSEMINATION: The study protocol and informed consent form were approved by the Institutional Ethics Committee of Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (SH9H-2022-T404-1). Findings will be disseminated to participants and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: ChiCTR2300068923.