The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study will be the comparison between THPP and PP in reducing the gingival index (GI) at the site of patch placement
研究概览
简要总结
Diabetes increases the incidence and severity of periodontal inflammation and disease, and periodontal disease causes an increase in the severity of diabetes by worsening glycemic control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on gingival tissue.The primary objective of this study is to determine the efficacy of the Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing gingival inflammation at the site of placement in diabetic patients. We also aim to determine if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP compared with placebo patch when applied to the mucosa in the treatment of gingival inflammation in diabetic patients.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the ages of 18 and 85 years
- •Patients must have a minimum of 3 posterior teeth in all quadrants
- •A mean gingival index (GI) of >1.5 on the posterior teeth
- •Diagnosis of Diabetes type 1 or 2, adequately controlled by diet and/or medications, as determined by the patient's physician
排除标准
- •Allergy to any herbal medications
- •Pregnancy or lactation
- •Periodontal treatment in the last three months
研究组 & 干预措施
A
Transmucosal Herbal Periodontal Patch (THPP)
干预措施: Transmucosal Herbal Periodontal Patch (THPP) (Drug)
B
Placebo Patch
干预措施: Placebo Patch (Drug)
结局指标
主要结局
The primary endpoint of the study will be the comparison between THPP and PP in reducing the gingival index (GI) at the site of patch placement
时间窗: 5 days
次要结局
- frequency and severity of any adverse event(5 days)
- Beta-glucuronidase enzyme found in gingival crevicular fluid (GCF) of the tested sites. The GCF will be collected from the second most posterior tooth in all four quadrants.(5 days)