Grape Seeds Extract Gel as an Adjunct to Scaling and Root Planing for the Treatment of Chronic Periodontitis: A Pilot Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline Pocket depth (PD) score
研究概览
简要总结
The aim of this study was to formulate a mucoadhesive gel of grapes seed extract (GSE) followed by short-term clinical study for the effectiveness of this gel onto the pocket depth (PD), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) when applied in periodontal pockets as an adjunct treatment for chronic periodontitis.
详细描述
Before commencing with the study, the trial proposal was registered in the research center and ethical clearance was taken from the ethical committee (FUGRP/2014/182)
Materials used in the study::
- Pure Grape Seed Extract (GSE) supplied by pure bulk supplements (Bulksupplements, USA). It contains natural ingredient of more than 180 mg of proanthocyanidins for every 200 mg of serving size of the powder. GSE has been considered safe by the National Center for Complimentary and Integrative Health if used orally for up to 8 weeks of clinical trials
- Carbapol "CB 934" (Loba Chemie Pvt. Ltd., Mumbai)
- Sodium- carboxy methly cellulose "Na-CMC" supplied (Loba Chemie Pvt. Ltd., Mumbai)
- Sodium phosphate monobasic and sodium phosphate dibasic (Acros organic Ltd., Mumbai)
- Parabens (Loba Chemie Pvt. Ltd., Mumbai)
Method of preparation:
GSE mucoadhesive gel preparation:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •being medically fit
- •non-smokers
- •has clinical diagnosis of chronic periodontitis with pockets depth of 5mm or greater along with evident radiographic bone Loss, and acceptance to provide an informed consent
排除标准
- •pregnant patients
- •breastfeeding mothers
- •patients who are taking dietary supplements
- •patients known to have grape's allergy
- •patients with hypertension or bleeding disorders
- •patients who have been under systemic or topical antibiotic treatments in the last 3 months
- •smokers, and patients who are taking any medications that may interact with GSE
研究组 & 干预措施
GSE mucoadhesive gel
2%GSE mucoadhesive gel administered in the periodontal pockets of GSE group at T0 and 3, 6, and 9 days after T0
干预措施: 2% GSE mucoadhesive gel (Dietary Supplement)
Control mucoadhesive gel
GSE free mucoadhesive gel administered in the periodontal pockets of Control group at T0 and 3, 6, and 9 days after T0
干预措施: GSE free mucoadhesive gel (Other)
结局指标
主要结局
Change from baseline Pocket depth (PD) score
时间窗: before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2)
PD will be measured for all sites and compared with PD scores at T0
次要结局
- Change from baseline Plaque index (PI)score(before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2))
- Change from baseline Gingival index (GI)score(before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2))
- Change from baseline Bleeding on probing (BOP)(before application of the gel (baseline T0), 4 weeks after first application (T1), 6 months after first application (T2))
研究者
Mohammad Ramadan Rayyan
Assistant professor
Riyadh Colleges of Dentistry and Pharmacy