Clinical Efficacy of Locally Delivered Aloe Vera Gel as an Adjunct to Non-surgical Periodontal Therapy in Chronic Periodontitis Subjects With Type 2 Diabetes Mellitus: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Clinical attachment level
研究概览
简要总结
The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).
详细描述
BACKGROUND: Advances in the field of alternative medicine have promoted widespread use of herbal agents, like Aloe vera (AV), for both medical and dental therapy. AV has anti-inflammatory, antioxidant, antimicrobial, hypoglycaemic, healing promoting and immune boosting properties. The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).
MATERIAL AND METHODS
A total of 60 subjects with probing depth (PD) ≥5mm and clinical attachment level (CAL) ≥3mm were randomly divided into two groups. Group 1 was treated with SRP + placebo gel local drug delivery (LDD) and Group 2 with SRP + AV gel LDD. Clinical parameters including full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and clinical attachment level (CAL) were recorded first at baseline and then at intervals of 3 months and 6 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
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Well-controlled type 2 DM
- •Chronic periodontitis with moderate to deep pockets [probing depth (PD) ≥5mm and clinical attachment loss (CAL) ≥3mm]
- •No history of antibiotic or periodontal therapy in the preceding 6 months.
排除标准
- •Any known disease/condition or on any medication that can affect the periodontal status
- •Known or suspected allergy to herbal medications
- •Systemic antimicrobial therapy
- •Aggressive periodontitis
- •Alcoholics
- •Immunocompromised patients
- •Pregnant or lactating females
研究组 & 干预措施
Placebo
After SRP, placebo gel was delivered subgingivally into periodontal pockets.
干预措施: placebo gel (Drug)
Aloe vera
After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.
干预措施: aloe vera (Drug)
结局指标
主要结局
Change in Clinical attachment level
时间窗: baseline to 6 months
次要结局
- Change in Probing depth(baseline to 6 months)
- Change in modified sulcus bleeding index(baseline to 6 months)
- Change in Plaque index(baseline to 6 months)
研究者
Dr. A R Pradeep
Professor & Head, Department of Periodontology
Government Dental College and Research Institute, Bangalore