Effect of Topical Melatonin on Osseointegration of Immediate Implants Placed in Chronically Infected Extraction Sockets: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Implant Stability Quotient (ISQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-50 years.
- •Non-restorable teeth associated with chronic apical lesions persisting after previous endodontic treatment and/or periapical surgery.
- •Adequate interarch relationship and interocclusal space for prosthetic rehabilitation.
- •Expected peri-implant jumping gap ≥2 mm.
- •Good oral hygiene and willingness to comply with follow-up visits.
- •The chronic periapical lesion of a predefined radiographic size range of [4 - 10 mm], measured as the maximum lesion diameter on preoperative CBCT.
排除标准
- •Alcohol or drug abuse.
- •Pregnancy.
- •Systemic conditions contraindicating implant placement.
- •Bruxism or other parafunctional habits.
- •Inability or unwillingness to maintain oral hygiene or attend follow-up visits.
研究组 & 干预措施
Melatonin Group
Local application of sterile 2% melatonin gel to the implant surface and mixed with Si-β-TCP putty bone substitute graft material placed in the peri-implant jumping gap after immediate implant placement.
干预措施: Topical Melatonin (Drug)
control group
Description: Immediate implant placement with Si-β-TCP putty bone substitute placement in the peri-implant jumping gap without melatonin application.
干预措施: Control (Other)
结局指标
主要结局
Implant Stability Quotient (ISQ)
时间窗: Baseline, 6 weeks, 3 months, 6 months, and 12 months after implant placement.
Implant stability will be assessed using resonance frequency analysis (Osstell Mentor device). The mean value of four measurements obtained around each implant will be recorded.
次要结局
- Marginal Bone Loss(Baseline and 6 months.)
- Relative Peri-implant Bone Density(6 months.)
- Postoperative Pain(Postoperative days 1, 3, and 7.)
- Soft Tissue Healing(7 and 14 days postoperatively.)
- Implant Survival(12 months after implant placement.)
- Postoperative Infection(7 days, 14 days, and 4 weeks postoperatively.)