Melatonin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- - Radiographic evaluation of the changes in the intrabony defect
研究概览
简要总结
Surgical periodontal therapy is a commonly employed treatment approach aimed at arresting disease progression and promoting tissue regeneration. Despite advancements in surgical techniques, adjunctive therapies are being explored to enhance the outcomes of periodontal surgical debridement. Melatonin, a hormone primarily known for its role in regulating the sleep-wake cycle, has emerged as a promising candidate for periodontal therapy. It possesses potent antioxidant, anti-inflammatory, and immunomodulatory properties, which make it an attractive therapeutic agent for treating periodontitis. Additionally, melatonin has been linked to bone metabolism, with evidence suggesting its involvement in bone formation and remodeling processes. Bone regeneration is a vital aspect of periodontal therapy, as the restoration of lost osseous structures is crucial for long-term stability of affected teeth. Previous studies have suggested that melatonin may exert positive effects on bone formation by promoting osteoblast differentiation, stimulating matrix synthesis, and inhibiting osteoclast activity. However, limited research has been conducted to specifically evaluate its influence on bone regeneration in the context of surgical periodontal flap therapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders within age range of 35-55 years.
- •Patients diagnosed with periodontitis Stage III (Caton et al., 2018; Papapanou et al., 2018).
- •Test site criteria: (probing pocket depth ≥6mm and CAL ≥5mm and 3-wall intrabondy defect). All these criteria will be determined after phase I conventional periodontal therapy.
- •Patients with three-wall intrabony defects.
- •Systemically free patients as evidenced by Burket's oral health history questionnaire (Glick et al., 2008)
- •Ability to attend the treatment sessions and comply with the procedures, recall visits and oral hygiene measures.
排除标准
- •Smokers. (Reynolds et al., 2015)
- •Drug abusers.
- •Pregnant or lactating females.
- •Patients under any medication that affect periodontal healing.
- •Vulnerable individuals.
研究组 & 干预措施
Melatonin gel with Xenograft group
Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft mixed with 5% melatonin gel.
干预措施: Melatonin gel mixed with xenograft (Drug)
Xenograft Only group
Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft alone.
干预措施: Xenograft (Other)
结局指标
主要结局
- Radiographic evaluation of the changes in the intrabony defect
时间窗: 6 months
The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph
次要结局
- Clinical evaluation of the changes in periodontal parameters(Baseline and 6 months)
- Evaluation of surgical wound healing(1 and 2 weeks after surgery.)
研究者
Muhammad Abdelnasser Ali Elnaggar
Principal investigator
Ain Shams University
