Effect of Ozone Gel on Alveolar Bone Density and Superoxide Dismutase in Chronic Periodontitis: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Superoxide dismutase activity
研究概览
简要总结
To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis.
详细描述
In this study, the investigators tested the effect of ozone gel as a local delivery system in treatment of chronic periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, a more rise in BD values as well as greater reduction in SOD activity compared to scaling and root planing (SRP) alone.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant's age ranged between 30 and 60 years.
- •All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm.
- •Willingness to participate and sign the informed consent.
排除标准
- •Any systemic disease that affect the periodontium.
- •Pregnancy, lactation, postmenopausal women
- •People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
- •People who use mouth washes regularly
- •Heavy smoking (> 10 cigarettes/day)
- •History of alcohol abuse.
- •Participation in other clinical trials.
研究组 & 干预措施
placebo gel
scaling and root planing with placebo gel
干预措施: placebo gel (Drug)
placebo gel
scaling and root planing with placebo gel
干预措施: scaling and root planing (Procedure)
Ozonated olive oil gel
scaling and root planing with Ozonated olive oil gel
干预措施: scaling and root planing (Procedure)
Ozonated olive oil gel
scaling and root planing with Ozonated olive oil gel
干预措施: Ozonated olive oil gel (Drug)
结局指标
主要结局
Superoxide dismutase activity
时间窗: 6 months
Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.
次要结局
- Gingival index(6 months)
- Probing pocket depth(6 months)
- Plaque Index(6 months)
- Bone density(6 months)
- Clinical attachment level(6 months)
研究者
Enas Elgendy
Lecuture, October 6 University
October 6 University