Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Clinical parameter of probing pocket depth
研究概览
简要总结
A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.
详细描述
Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing.
The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months.
HbA1c evaluated at baseline and 3 months.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 30 - 55 years from both genders.
- •Patients with controlled Type II Diabetes Mellitus (HbA1c < 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
- •Patients on oral hypoglycaemic agents.
- •Subjects who have not received periodontal therapy within preceding 6 months.
- •Patients willing to comply with all study related procedures.
排除标准
- •Subjects who have received antibiotic treatment in the preceding 3 months.
- •History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
- •Pregnant or lactating women.
- •History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
- •Unwilling patients
研究组 & 干预措施
SRP+ Aloe Group
Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.
干预措施: SRP + Aloe (Drug)
SRP Group
Only scaling and root planing was done on the opposite side.
干预措施: SRP (Procedure)
结局指标
主要结局
Clinical parameter of probing pocket depth
时间窗: 3 months
Clinically change in the probing pocket depth.
次要结局
- Clinical parameter of gingival index(3 months)
- Glycosylated haemoglobin(3 months)
- Clinical parameter of relative attachment level(3 months)
- Clinical parameter of plaque index(3 months)
研究者
Dr. Gurbani Kaur
Effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with diabetes mellitus: Randomized controlled clinical trial
Dr. D. Y. Patil Dental College & Hospital