Comparative evaluation of topical application of Argyreia Speciosa gel andTriphala gel as an adjunct to scaling in treatment of gingivitis: A clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in gingival inflammation and plaque formation
研究概览
简要总结
Aim of the study is to compare the effect of topical application of Argyreia Speciosa gel and Triphala Gel as an adjunct to scaling with scaling alone in terms of reduction in dental plaque, gingival inflammation along with gingival bleeding in gingivitis. All the participants will be explained about the need, design of study. Informed written consent will be obtained from the patients. Clinical case history will be recorded. All the clinical parameters (GI, SBI, PI) will be recorded at baseline using UNC 15 periodontal probe (Hu Friedy). Each patient will undergo ultrasonic scaling (EMS) by a single operator. It is a single blind study in which the patient will be randomly assigned to either topical application of Argyreia Speciosa gel orTriphala Gel as an adjunct to scaling or scaling alone using “Computer generated†method. After full-mouth scaling, subjects from test group will be instructed to take a pea size portion of the Argyreia speciosa gel or Triphala Gel on the index finger and gently massage all over the gingiva, twice a day after brushing for 15 days as directed by the manufacturer. Patients will be instructed to follow the standard advised oral hygiene measures. The subjects who missed the application of gel will be excluded from the study. The subjects will be re-evaluated for the GI, SBI and PI after 15 days. All the clinical parameters will be recorded at baseline and after 15 days by second blinded operator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic gingivitis patients with a minimum of 16 gradable teeth.
- •Systemically healthy patients.
- •Patients requiring scaling.
- •Both males and females between the age group of 20-60 year with ≤ 3 mm of probing depth (PD).
- •Patient not on systemic antibiotics for the past 3 months.
- •No use of anti-inflammatory drugs within the past 3 months 7) Availability of the patient for the entire duration of the study.
- •Not receiving periodontal treatment within last 6 months.
- •Patient should be able to understand and give a written informed consent.
排除标准
- •Patients with history of deleterious habits (i.e., use of tobacco consumption etc.) 2) Patients with systemic diseases (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases).
- •Patients on systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy prescribed or received within 2 months prior to study entry.
- •Pregnant and/or lactating females.
- •Patients contraindicated for scaling.
结局指标
主要结局
Reduction in gingival inflammation and plaque formation
时间窗: Baseline to 15 Days
次要结局
- -(-)