Background: Photodynamic therapy (PDT) can be used for the management of peri-implantitis. This study aimed to explore the efficacy and safety of PDT for peri-implantitis in Chinese Han patients. Methods: This was a single-centre, open-label, randomized controlled trial of participants with peri-implantitis treated at the Beijing Chao-Yang Hospital, randomized 1:1 to PDT or no PDT. PDT was performed using toluidine blue (10 mg/ mL; 3 min) and a 635-nm laser (750 mW; 10 s/implant side; minimum of 60 mW/cm 2 ). The primary outcome was the decline in periodontal probing depth (PD) at 6 months. The secondary outcomes were peri-implant plaque index (PLI), sulcular bleeding index (SBI), and clinical attachment loss (CAL). Results: PD after treatment was smaller in the PDT group (n = 66) than in controls (n = 65) (all P < 0.001 vs. baseline). At 1 month, compared with controls, the PD in the PDT group was larger, while at 3-and 6-month, the PDs were smaller (all P < 0.001). CAL, PLI and SBI in the PDT group was better (P < 0.05 vs. controls). Conclusion: PDT combined with mechanical debridement significantly improves PD, PLI and SBI in participants with peri-implantitis. Importantly, PDT achieved a better CAL than mechanical debridement and cleaning.Abbreviations: AE = adverse event; CAL = clinical attachment loss; DB = distobuccal; PD = pocket depth; PDT = Photodynamic therapy; PLI = peri-implant plaque index; SBI = sulcular bleeding index.