Clinical Efficacy of Non-surgical Therapy With Adjunctive Local Delivery of Ozonated Olive Oil Gel Versus Curcumin Gel in Stage II Grade B Periodontitis Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical attachment level
研究概览
简要总结
The aim of this clinical trial is to evaluate the effectiveness of local delivery ozonated olive gel versus curcumin gel as adjunct to scaling and root planing in the treatment of stage II grade B periodontitis in on both males and females in the age group between 18 and 50 years. outcome measures are Clinical attachment level (CAL), plaque index (PI), gingival index (GI).
详细描述
Periodontitis is an advanced periodontal disease with a distinctive clinical signs and symptoms as rapid attachment loss and bone destruction
The primary treatment approach for periodontitis is mechanical plaque removal through debridement, particularly scaling and root planing (SRP) using hand or ultrasonic instruments.
curcumin gel is an adjunct to non-surgical periodontal therapy is a highly potent local antioxidant and anti-inflammatory agent. While ozone has a potent antimicrobial and anti-inflammatory effects it also can be incorporated into a lipid carrier such as olive oil. Ozone's stability and ease of application are markedly enhanced. Ozonized olive oil can be formulated into a gel with ideal rheological properties for injection into periodontal pockets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with stage II periodontitis defined by having interdental CAL 3-4 mm and presence of pocket depth (PD) ≤ 5 mm, and grade B periodontitis characterized by a moderate rate of disease progression.
- •Patients agree to a 3-month follow-up period and provide an informed consent.
排除标准
- •Presence of prosthetic crowns, overhanging restorations and orthodontic treatment.
- •Teeth with both endo-perio lesions.
- •Antibiotics therapy that has an impact on the clinical signs and symptoms of periodontitis in the previous 3 months.
- •Anti-inflammatory drugs in the previous 1 month.
- •6. History of systemic disease, allergy, cardiovascular diseases, diabetes mellitus, hypertension, bleeding disorders, hyperparathyroidism, and compromised medical conditions, pregnant and lactating females.
研究组 & 干预措施
ozonated olive gel.
full-mouth SRP + subgingival application of ozonated olive oil gel
干预措施: full mouth non-surgical scaling (Procedure)
curcumin gel
full-mouth SRP + subgingival application of curcumin gel
干预措施: full mouth non-surgical scaling (Procedure)
placebo gel
full-mouth SRP followed by subgingival application of placebo gel
干预措施: full mouth non-surgical scaling (Procedure)
结局指标
主要结局
Clinical attachment level
时间窗: 3 months
measured from the cementoenamel junction (CEJ) to the bottom of pocket.
Clinical attachment level
时间窗: 3 months
measured from the cementoenamel junction (CEJ) to the bottom of pocket.
次要结局
- Gingival Index(3 months)
- Gingival Index(3 months)
- Plaque index(3 months)
研究者
Parryhan Mohamed Abdelsamie
Lecturer of periodontology
Cairo University