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临床试验/CTRI/2023/05/052310
CTRI/2023/05/052310已完成4 期

Comparative evaluation of anti-plaque and anti-inflammatory effect of topical application of Argyreia Speciosa gel as an adjunct to scaling: A clinical study

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月5日最近更新:

试验速览

阶段
4 期
状态
已完成
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 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 were explained about the need, design of study. Informed written consent was obtained from the patients. Clinical case history was recorded. All the clinical parameters (GI, SBI, PI) were recorded at baseline using UNC 15 periodontal probe (Hu Friedy). Each patient were undergo ultrasonic scaling (EMS) by a single operator. It is a single blind study in which the patient was randomly assigned to either topical application of Argyreia Speciosa gel as an adjunct to scaling or scaling alone using “Computer generated†method. After full-mouth scaling, subjects from test group were instructed to take a pea size portion of the Argyreia speciosa 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 was instructed to follow the standard advised oral hygiene measures. The subjects who missed the application of gel was excluded from the study. The subjects was  re-evaluated for the GI, SBI and PI after 15 days. All the clinical parameters were 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 2)Systemically healthy patients 3)Patients requiring scaling 4)Both males and females between the age group of 20-60 years with 3mm of probing depth 5)Patient not on systemic antibiotics for the past 3 months 6)No use of anti-inflammatory drug within the past 3 months 7)Availability of the patient for the entire duration of the study 8)Not receiving periodontal treatment within last 6 months 9)Patient should be able to understand and give a written inform 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

  • -(-)

研究者

发起方
未提供

研究点 (1)

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