Melatonin in Posterior Mandible Extraction Socket
Effect of Local Melatonin Gel Versus Placebo Gel Application on Bone Regeneration in Mandibular Posterior Teeth Extraction Sockets With Radiographic and Histopathological Evaluation: A Randomized Clinical Trial
This study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. It will include patients aged 18-30 years presenting with non-restorable mandibular molars indicated for extraction and delayed implant placement.
Eligible patients will be randomly allocated into two equal groups:
- Group I (Intervention group): Extraction sockets will be filled with locally applied melatonin gel.
- Group II (Control group): Extraction sockets will be filled with placebo gel. All patients will undergo atraumatic tooth extraction under local anesthesia, followed by socket curettage, saline irrigation, application of the allocated gel, collagen membrane coverage, and primary wound closure.
Postoperative care will include standardized medications and oral hygiene instructions. Patients will be followed up clinically and radiographically. CBCT will be used to assess the primary outcome, which is the dimensional change in vertical alveolar bone height (ΔH). At 12 weeks, core biopsy specimens will be obtained for histopathological assessment of bone quality, including newly formed bone, bone maturation, trabecular architecture, and osteoblastic activity.
Sample size: The total sample size will be determined based on the primary outcome (ΔH), using an appropriate statistical power calculation, with equal allocation between the two groups. The final number of participants will be specified according to the statistician's sample size calculation.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients aged 18-30 years
- Presence of non-restorable mandibular molars indicated for extraction
- Patients with good general health
- Adequate oral hygiene
- Patients willing to undergo implant placement after 4 months
- Patients who provide informed consent
Exclusion Criteria:
- Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
- Patients receiving medications affecting bone metabolism (e.g., corticosteroids, bisphosphonates)
- Heavy smokers
- Presence of acute infection or pathological lesions at the extraction site
- Pregnant or lactating females
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：安慰剂组
|
Eligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline. The extraction socket will be filled with locally applied placebo gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures. All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone quality. |
|
实验性的：melatonin group
|
Eligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline. The extraction socket will be filled with locally applied melatonin gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures. All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone qualit |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the dimensional change in vertical alveolar bone height
大体时间：12 weeks
|
radiographically by cone beam C.T |
12 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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