CLINICAL AND RADIOGRAPHIC EVALUATION OF EFFECT OF OXYGEN-RELEASING FORMULA GEL AND CHLORHEXIDINE GEL AS AN ADJUNCT TO NONSURGICAL THERAPY IN CONTROLLED TYPE II DIABETIC PATIENTS WITH STAGE II GRADE B PERIODONTITIS – A SPLIT MOUTH STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This split-mouth, double-blind, randomised controlled clinical trial aims to evaluate the clinical and radiographic efficacy of an oxygen-releasing formula gel and a chlorhexidine gel as adjuncts to scaling and root planing in controlled type II diabetic patients with Stage II Grade B periodontitis. A total of 30 patients will be included, with each quadrant randomly assigned to SRP alone, SRP with oxygen releasing gel, SRP with chlorhexidine gel, or SRP with placebo gel. Clinical parameters such as Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, and Bleeding on Probing will be assessed at baseline, 3 months, and 6 months. Radiographic evaluation using standardised intraoral periapical radiographs will measure radiographic linear defect depth and defect angle at baseline and 6 months to assess bone changes. The study aims to compare the effectiveness of these adjunctive therapies in improving periodontal health and bone healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 22.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects who are diagnosed with clinical Stage II periodontitis grade B and are willing to undergo treatment.
- •Patients 20 to 55 years of age
- •Patients with periodontal pocket depth less than or equal to 5mm in at least in 2 quadrants
- •A minimum of 15 teeth should remain.
- •Patients with controlled Type 2 diabetes (HbA1C less than 7),
- •less than 10 cigarettes per day.
排除标准
- •Use of antibiotics in the past 6 months
- •Steroid or inflammatory drugs for 7 days in 3 months
- •Known allergy to the above-mentioned drugs/substances
- •Alcoholic
- •Pregnant and lactating women
- •Periodontal therapy within 6 months.
研究者
Dr Achsa Annie Kurian
Coorg Institute of Dental Sciences
