Topical Melatonin for Immediate Implants in Chronically Infected Extraction Sockets

Overview

The purpose of this study is to evaluate the effect of topical 2% melatonin gel on implant stability and osseointegration of immediate implants placed in chronically infected extraction sockets. Sixty patients requiring extraction of non-restorable teeth associated with chronic apical lesions will be randomly assigned to receive either conventional immediate implant placement with bone graft only or immediate implant placement with adjunctive topical melatonin. Implant stability will be assessed using resonance frequency analysis over a 12-month follow-up period. Secondary outcomes will include marginal bone loss, peri-implant bone density, postoperative pain, soft tissue healing, postoperative infection, and implant survival.

Immediate implant placement has become a predictable treatment modality that shortens treatment time and helps preserve alveolar bone architecture. Although successful outcomes have been reported in chronically infected extraction sockets following meticulous debridement and infection control, the inflammatory environment may adversely affect early bone healing and osseointegration. Melatonin (N-acetyl-5-methoxytryptamine) exhibits antioxidant, anti-inflammatory, antimicrobial, and osteogenic properties that may enhance peri-implant bone regeneration. Previous studies have suggested that topical melatonin can stimulate osteoblastic activity, increase bone formation, and improve implant stability. However, evidence regarding its effectiveness in immediate implant placement within chronically infected extraction sockets remains limited. This study is designed as a quadruple-blinded, parallel-arm randomized controlled clinical trial involving 60 participants. Following atraumatic extraction, thorough socket debridement, immediate implant placement, and grafting of the peri-implant jumping gap, participants will be allocated to one of two treatment groups. In the experimental group, a sterile 2% melatonin gel will be applied to the implant surface and mixed with the grafting material before placement. Clinical and radiographic outcomes will be evaluated for 12 months following implant placement.