Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse
关键词
抽象
描述
The aim of this study was to investigate the effects of a Traditional Chinese medicine (TCM) mouthrinse on gingival health and microbial profiles in orthodontic patients. This six-month randomized, single-blinded, parallel controlled clinical trial consists of 90 patients with fixed appliance treatment. The subjects were allocated to (1) negative-control group: oral hygiene instruction (OHI) alone; (2) positive-control group: OHI plus an EO mouthrinse (Listerine®)(3) test group: OHI plus the TCM mouthrinse (5% Fructus mume extract). Clinical examinations included Plaque Index (PI), Bleeding Index (BI) and Modified Gingival Index (MGI). Salivary microbial quantifications included total aerobic and anaerobic bacteria, Streptococci and Lactobacilli counts. Clinical and microbiological examinations were conducted at baseline, 3 and 6 months (T1, T2 and T3).
日期
| 最后验证: | 06/30/2012 |
| 首次提交: | 01/02/2012 |
| 提交的预估入学人数: | 07/09/2012 |
| 首次发布: | 07/10/2012 |
| 上次提交的更新: | 07/09/2012 |
| 最近更新发布: | 07/10/2012 |
| 实际学习开始日期: | 09/30/2010 |
| 预计主要完成日期: | 04/30/2011 |
| 预计完成日期: | 12/31/2011 |
状况或疾病
干预/治疗
Drug: Listerine
Drug: Chinese medicine mouthrinse
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Listerine essential oil mouthrinse | Drug: Listerine For six months |
| No Intervention: Negative control without intervention | |
| Experimental: Chinese medicine mouthrinse 5% Fructus Mume extract and 2% sodium bicarbonate | Drug: Chinese medicine mouthrinse six months |
资格标准
| 有资格学习的年龄 | 13 Years 至 13 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Subjects who have at less 20 permanent teeth - Subjects who have a healthy systemic condition - Subjects with age range 13-35. - Subjects who are no-smoker; - Subjects who haven't taken antibiotic medicine within a 2 week period prior - Subjects who do not currently undergo any medication or will undergo any medication in next six months - Subjects who have not dental diseases that required ongoing treatment, which would confound the evaluation of result - Subjects who are competent in giving consents - Subjects who are not pregnant or lactating women - Subjects who do not report teeth sensitivity - Subjects who are not allergic to ethanol - Subjects presented a minimum level of pre-existing gingivitis (MGI>1) but without peridontitis.(probing depth>4mm) |
结果
主要结果指标
1. Gingival index [6 months]
2. Plaque index [6 months]
3. gingival bleeding index [6 months]
次要成果指标
1. Salivary cytokines [6 months]
2. Adverse Events [6 months]
3. Salivary bacteria counts [6 months]
