跳至主要内容
临床试验/NCT04032132
NCT04032132已完成4 期

The Local Application of Curcumin in Conjunction With the Surgical Treatment of Intrabony Periodontal Defects "Controlled Clinical Study With Evaluation of Curcumin Release Profile"

Ain Shams University0 个研究点目标入组 24 人开始时间: 2016年8月20日最近更新:
适应症
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
24
主要终点
clinical score

研究概览

简要总结

The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. This study will be carried out to examine the effect of curcumin when used in conjunction with open flap debridement treating deep periodontal pockets. (suggesting that it may have positive effect)

详细描述

The present study entailed twenty four patients having stage II or stage III, Grade A periodontitis with 24 intrabony defects. Patients were divided into two groups; group I was subjected to open flap debridement only. Group II was subjected to curcumin paste (2%curcumin)in conjunction with open flap debridement Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin paste.The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.

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
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female with age range 25-45 years.
  • At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann & Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.
  • Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).

排除标准

  • 1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)

研究组 & 干预措施

curcumin paste in conjunction with open flap debridement surge

Experimental

curcumin paste (2% circumin) in conjunction with open flap debridement surgery

干预措施: curcumin paste (Drug)

curcumin paste in conjunction with open flap debridement surge

Experimental

curcumin paste (2% circumin) in conjunction with open flap debridement surgery

干预措施: curettage (Procedure)

open flap debridement surgery only

Placebo Comparator

surgical treatment for periodontal pocket

干预措施: curettage (Procedure)

结局指标

主要结局

clinical score

时间窗: change from base line at 6 months

Evaluate the influence of curcumin paste on the clinical outcomes of the surgical treatment.to see if curcumin has a positive effect in reduction oh deep periodontal pockets and leads to greater bone gain

次要结局

未报告次要终点

研究者

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

Yasmine Gamal

Administrator of oral medicine and periodontology

Ain Shams University

相似试验