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临床试验/NCT06821425
NCT06821425已完成4 期

Melatonin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月1日最近更新:
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Abdelnasser Ali Elnaggar

Principal investigator

Ain Shams University

研究点 (1)

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