SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Gingival Index
研究概览
简要总结
The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste perception, malodor and calculus.
详细描述
Study Population A 10 week double-blinded, randomized clinical study will be conducted on 80 subjects diagnosed with plaque induced gingivitis and/or chronic periodontitis. The study will take place at Saint Louis University Center for Advanced Dental Education and Southern Illinois University School of Dental Medicine.
Research Design and Methods Visit 1 Subjects who sign the informed consent and medical history forms and meet the preliminary entrance criteria will be examined at baseline. All participants will be informed of the nature of the study, its purpose, and any possible risks. Subjects will also be informed as to the length of the study and the specific procedures that will be carried out. Subjects will be informed that this is a voluntary study and that they are free to withdraw from the study at any time.
Clinical measurements of plaque and gingival indices will be taken. A gingival bleeding score will be determined. Examiners will be standardized for scoring.
Gingival index (GI) will be measured using the Loe and Silness method (Loe and Silness 1963). The gingiva will be scored at six sites of each tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual) and given a score from 0 - 3. By adding the scores and dividing by the total number of sites, the GI for the patient will be obtained. The following criteria will be used for scoring:
0 - Absence of inflammation
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the ages of 18 to 80
- •Subjects with a diagnosis of gingivitis or chronic periodontitis
- •Entry levels of gingival inflammation and plaque accumulation will be present (mean Gingival Index ≥ 0.4 and Plaque Index ≥ 1.0)
- •Subjects that are in good medical health at time of the study
- •At least 20 permanent natural teeth
排除标准
- •Use of local or systemic antibiotics during the course of the study
- •Subjects that are pregnant or nursing mothers
- •Subjects undergoing orthodontic therapy
- •Subjects wearing removable prostheses
- •Subjects taking medication which is altering the gingiva or causing inflammation
- •Gingival overgrowth
- •History of sensitivity or suspected allergies following the use of oral hygiene products
- •Subjects taking anti-inflammatory or anticoagulant medications that would alter the gingiva and promote bleeding
- •Subjects that require antibiotic prophylaxis prior to dental treatment
- •Subjects that have acute dental problems requiring immediate treatment
研究组 & 干预措施
Group 1 SmartMouth
24 subjects with plaque and gingival inflammation
干预措施: SmartMouth Clinical DDS mouthrinse (Drug)
Group 2 Chlorhexidine
28 subjects with plaque and gingival inflammation
干预措施: 0.12% chlorhexidine rinse (Drug)
Group 3 Placebo
28 subjects with plaque and gingival inflammation
干预措施: Placebo rinse (Drug)
结局指标
主要结局
Gingival Index
时间窗: 6 weeks
Gingival Index scores gingival inflammation from 0 (healthy) to 3 (severe inflammation). The higher the score, the greater the gingival inflammation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
次要结局
- Calculus Index(6 weeks)
- Tooth Stain Index(6 weeks)
- Bleeding Score(6 weeks)
- Plaque Index(6 weeks)
研究者
D. Douglas Miley, D.M.D., M.S.D
Primary Investigator
St. Louis University