Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Concentration of cytokines.
研究概览
简要总结
The aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. Two regions will be operated in a selected patient. One region will receive fibrin sealant (test site) and the other region will get sutures (control site). Wound healing will be assessed by evaluating inflammatory markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.
Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels of interleukin (1beta and 8) compared to use of sutures.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject has to be between the ages of 18 and 60 years.
- •Severe Periodontitis: Presence of a jaw with each quadrant having atleast 4 teeth with a probing depth of ≥ 6mm and is indicated for periodontal flap surgery.
- •Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
- •Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.
- •Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.
- •Endodontic status: Teeth had to be vital or properly treated with root canal therapy
排除标准
- •History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
- •Current or former smokers.
- •Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
- •Mobility of selected teeth.
- •Pregnant or lactating women.
研究组 & 干预措施
Fibrin Sealant
One quadrant surgically elevated will be closed with fibrin sealant
干预措施: Fibrin Sealant (Drug)
Suture
The surgically elevated flap is closed with non resorbable sutures.
干预措施: Suture (Drug)
结局指标
主要结局
Concentration of cytokines.
时间窗: 7 days
Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.
次要结局
- Clinical inflammation(7, 14 and 21 days)
研究者
Dr Shaju Jacob P
Professor
Chhattisgarh Dental College and Research Institute