The Evaluation of the Effect of Local Melatonin Application Around Immediately Placed Implants in the Maxillary Premolars (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Osteoprotegerin
研究概览
简要总结
Background: Immediate implants provide ideal three-dimensional positioning compared to conventional implants. There may be a gap between the surface of the implant and the bone walls of the socket when it is inserted into a recently extracted alveolus. To compensate for this, various grafting materials are used. Recently, melatonin has gained significant attention because of its inhibitory action on bone resorption through upregulating the expression of osteoprotegerin, which acts as a decoy receptor for RANKL and inhibits its binding to osteoclast precursors thereby inhibiting osteoclast formation and activity. So, we will conduct this study to evaluate the effects of local melatonin application around immediately placed implants.
Aim of the study: To evaluate the effectiveness of adding local melatonin around immediately placed implants in maxillary premolars.
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
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-restorable maxillary premolars with sufficient bone quantity to receive the dental implant without the need for bone graft.
- •Patients with no local or systemic pathology that can interfere with normal wound healing.
- •Non-smokers.
- •Patients who are properly motivated to complete follow-up visits
排除标准
- •Patients with uncontrolled medical conditions that can affect surgical outcome or bone and wound healing. (ex: uncontrolled diabetes mellitus)
- •Patients with periapical pathology that may contraindicate immediate implant placement.
- •History of receiving irradiation in the head and neck region
研究组 & 干预措施
melatonin therapy
干预措施: Immediately placed implant in maxillary premolars with local melatonin application (Other)
No melatonin
干预措施: Immediately placed implant in maxillary premolars without local melatonin application (Other)
结局指标
主要结局
Change in Osteoprotegerin
时间窗: Baseline, 1 month, and 3 months
OPG (Ng/ml) level will be measured preoperatively, 1 and 3 months post operatively, to evaluate the bone healing activity. The level will be evaluated by collecting 5 ml of peripheral blood in blank tubes and will be allowed for complete clotting and will be centrifuged at 1000 g for 15 min. The separated serum will be then stored at -20 0C.
Change in bone volume
时间窗: Baseline and 6 months
CBCT scans will be obtained to measure change in bone volume
Change in bone level
时间窗: Baseline and 6 months
CBCT scans will be obtained to measure change in bone level
Change in bone density
时间窗: Baseline and 6 months
CBCT scans will be obtained to measure change in bone density
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University