COMPARATIVE EVALUATION OF TOPICAL APPLICATION OF ARGYREIA SPECIOSA GEL AND OCIMUM SANCTUM GEL AS AN ADJUNCT TO SCALING IN TREATMENT OF GINGIVITIS: A RANDOMISED CONTROLLED CLINICAL TRIAL.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Reduction in gingival inflammation and plaque
研究概览
简要总结
Aim of the study is to compare the Clinical efficacy of topical application of Argyreia speciosa gel and Ocimum sanctum gel as an adjunct to scaling 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 Group 1 (Scaling + Argyreia speciosa gel), Group 2 (Scaling + Ocimum Sanctum gel) or Group 3 (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 either Argyreia speciosa gel (MGT Gel) or Ocimum Sanctum 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 with a reminder given via phone call to use gel efficiently for optimal oral health benefits. From test group patients will be asked to bring back the given tube at the 15 days follow-up appointment. 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 the blinded assessor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 less than or equal to 3 mm of probing depth (PD).
- •Availability of the patient for the entire duration of the study.
- •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.
- •Patient on systemic antibiotics for the past 3 months.
- •Use of anti-inflammatory drugs within the past 3 months.
- •Patient receiving periodontal treatment within last 6 months.
结局指标
主要结局
Reduction in gingival inflammation and plaque
时间窗: BASELINE AND AFTER 15 DAYS
formation.
时间窗: BASELINE AND AFTER 15 DAYS
次要结局
未报告次要终点
研究者
Dr Kaushik Sunil Kothimbire
SMBT Dental College and Hospital Sangamner