Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Periodontal pocket depth (PPD)
研究概览
简要总结
The present study will be performed on fourty-five patients suffering from periodontitis according to the criteria of American academy of periodontology to evaluate clinically effect of topical application of insulin versus hyaluronic acid as an adjunct to non surgical periodontal therapy in stage Ⅲ periodontitis patients.
This will be done by:
- Clinical assessment.
- Biochemical analysis. - Dose the topical application of insulin or hyaluronic acid as an adjunct to non-surgical periodontal therapy improves periodontal condition in stage Ⅲ periodontitis patients? PICO P (Population): patients with stage Ⅲ periodontitis. I (Intervention): non surgical periodontal therapy (SRP) with topical application using insulin or hyaluronic acid in periodontal pockets.
C (Comparison): topical application of insulin versus hyaluronic acid and SRP alone in periodontal pocket.
O (Outcome): primary outcome: change in periodontal pocket depth (PPD) or clinical attachment loss (CAL). Secondary outcome: change in gingival index (GI) or bleeding on probing index (BOP) and levels of IL-1β in GCF of treated pocket.
Study type: Randomized controlled trials (RCTs).
详细描述
The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.
The randomization of patients will form the following 3 groups:
Group (Ⅰ): control group including (15) stage Ⅲ periodontitis patients who will receive scaling and root planning (SRP) alone.
Group (Ⅱ): including (15) stage Ⅲ periodontitis patients who will receive topical application of insulin adjunct to SRP.
Group (Ⅲ): including (15) stage Ⅲ periodontitis patients who will receive topical application of hyaluronic acid adjunct to SRP.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All selected patients are free from systemic illness as evaluated according to dental modification of the Cornell medical index.
- •Should be diagnosed as having periodontitis.
- •Not received any type of periodontal treatment in the past 6 months prior to examination.
- •Should be cooperative, motivated, and willing to follow our treatment protocol and follow up visits.
- •Not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
排除标准
- •Antibiotic therapy in the preceding 6 months or during study participation.
- •History of insulin dependent diabetes and thyroid disease.
- •Pregnancy, smoking, chronic diseases such as diabetes mellitus or rheumatoid arthritis, and allergy to ingredients in the drug.
- •Poor oral hygiene compliance or inability to adhere to the clinical protocol.
结局指标
主要结局
Periodontal pocket depth (PPD)
时间窗: 3-6 months
(PD) measured in (mm) from free gingival margin to the base of the pocket at six sites per tooth (mesiobuccal and mesiolingual, distobuccal and distolingual, and mid-buccal and mid-lingual regions).
Clinical attachment loss (CAL)
时间窗: 3-6 months
(CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth.
次要结局
- Change in gingival index (GI)(3-6 months follow up)
- Change in bleeding on probing index (BOP)(3-6 months follow up)
- Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket(3-6 months follow up)
研究者
Doaa Atta Aid
Doctor
Faculty of Dental Medicine for Girls