Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- wound healing index
研究概览
简要总结
Abstract Aim:The Enoxolone (18β-glycyrrhetinic acid; BGA) is a bioactive compound in licorice that exhibits potential anti-ulcer, anti-inflammatory, and anti-microbial activities, relieve oral ulcers, pain, improve gingivitis and dental plaque from past relevant experimental studies,but few clinical trials have evaluated its clinical effectiveness. Therefore, the purpose of this study is to evaluate the effectiveness of Enoxolone on oral conditions of patients with periodontal surgery. Methods:This study is a randomized controlled trial. Patients with severe chronic periodontitis who needed to accept periodontal surgery were randomly assigned to two groups, the experimental group was Enoxolone toothpaste, and the control group for Sensodyne toothpaste. After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. Data set performs repeated-measures for the change in mean differences by using the two-tailed independent t tests and generalized linear model.
详细描述
Enoxolone is a toothpaste containing 18β-glycyrrhetinic acid (BGA). In this study, the experimental group used Enoxolone toothpaste, and the control group did not contain BGA toothpaste (Sensodyne), which is used for oral cleaning of patients after periodontal disease surgery. The absorption rate is very low, and it will not cause any interaction with western medicine.
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
- None
盲法说明
The experimental group and the control group were randomly assigned by lottery drawing.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are over 20 years old.
- •Those whose health or systemic diseases are well controlled.
- •Those with severe chronic periodontitis who need to perform periodontal surgery after being diagnosed by a doctor.
- •Subjects who are willing to accept this study.
排除标准
- •Allergy to licorice.
- •Pregnancy or breastfeeding.
- •Periodontal surgery completed at the same site within 6 months.
- •Severe bone loss in the apical tissue of the surgical site (including poor prognosis).
- •Clinical signs of infection, including fistula, suppuration, fever, severe pain and site swelling.
- •Platelets less than 50,000.
结局指标
主要结局
wound healing index
时间窗: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
epithelization and color matching score: A score of 0-10, higher indicates better wound healing.
次要结局
- patient-reported pain score, painkillers(after operation 1week)
- Periodontal pocket depth, Gingiva index, Plaque index(after operation 1st, 2nd, 3rd, 4th, 8th, 12th week)