21 Day Clinical Efficacy of Essential Oil Containing Mouth Rinses: Effect on Reducing Existing Gingivitis and Plaque
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Whole Mouth Mean Modified Gingival Index (MGI) at Week 3
研究概览
简要总结
The reduction of existing plaque and gum inflammation will be evaluated using two marketed mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth rinse.
165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2) Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain a diary at home to record each treatment use and will be asked to come to the clinic without brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.
详细描述
A sufficient number of generally healthy subjects (approximately 165) that meet the required inclusion/exclusion criteria will be enrolled in this 21 day, examiner-blind, single center, randomized, parallel-group controlled clinical trial to ensure that at least 150 subjects (50 per treatment group) complete this study.
At baseline, the prescreened subjects will present to the clinic site for baseline examinations (oral tissue assessment, gingivitis, bleeding and plaque assessments) having refrained from oral hygiene for at least 8 hours, but no more than 18 hours. After the baseline oral examinations, assessment of other inclusion/exclusion criteria qualifying subjects will be randomly assigned to one of three treatment groups. Immediately following this randomization, subjects will begin use of their assigned test product following the label instructions. If randomized to the control group, subjects will brush twice daily in their usual manner with an ADA accepted fluoride toothpaste and a soft bristled toothbrush followed by rinsing twice daily with a 5% hydroalcohol control rinse (W002194-221P). If randomized to an active treatment group; subjects will brush twice daily in their usual manner, followed by rinsing twice daily with their assigned mouth rinse formulation (19292-116A or 11965-059). Subjects will be instructed to follow label instructions 20ml for 30 seconds twice daily for mouth rinse product. The first product use will be conducted under the supervision of study personnel. All other brushing and rinsing will be unsupervised and the subjects will be required to maintain a diary card to document twice daily product use, brushing and rinsing times. Compliance will be evaluated by weighing residual volumes of returned mouth rinse and by reviewing the subject diary. Subjects will receive an ADA- accepted fluoride-containing dentifrice and a soft bristled toothbrush at their baseline visit.
Subjects may continue to use floss to remove impacted food between the teeth if it is part of their usual oral care regimen during the course of the study; no other oral hygiene procedures will be permitted, including teeth cleaning, whitening or dental procedures except for an emergency treatment. The decision to withdraw a subject due to emergency dental treatment will occur at the discretion of the Investigator.
At baseline and three weeks (±2 days) visits, subject will not have brushed or have used their product for at least 8 hours, but no more than 18 hours.
Oral tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI) will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouth rinses and red food dye;
- •Dental prophylaxis within 2 weeks prior to Screening visit;
- •Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within one month prior to the baseline exam;
- •Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouth rinses within three weeks prior to baseline;
- •Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);
- •Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator;
- •Participation in any other clinical study within 30 days of Visit 1;
- •Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson & Johnson subsidiaries, contractors of Johnson & Johnson, and the families of each); and
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, substance or alcohol abuse or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study.
结局指标
主要结局
Whole Mouth Mean Modified Gingival Index (MGI) at Week 3
时间窗: 3 Weeks
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Whole Mouth Mean Plaque Index (PI) at Week 3
时间窗: 3 Weeks
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.
次要结局
- Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3(Baseline to 3 Weeks)
- Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3(Baseline to 3 Weeks)
- Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3(Baseline to 3 Weeks)
- Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3(Baseline to 3 Weeks)
- Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3(3 Weeks)
- Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3(Baseline to 3 Weeks)
- Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3(Baseline to 3 Weeks)