Clinical Research Study Efficacy of a Prototype Oral Rinse
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Gingival Index
研究概览
简要总结
Evaluate the efficacy of an oral rinse on dental plaque and gingival 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers 18-65 years of age
- •Good general health
- •Must sign informed consent form
- •Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
- •No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
- •Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥
- •Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.
- •heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0
排除标准
- •Subjects unable or unwilling to sign the informed consent form.
- •Medical condition which requires pre-medication prior to dental visits/procedures
- •Moderate or advanced periodontal disease
- •History of allergy to iodine
- •History of thyroid disease
- •History of diabetes
- •2 or more decayed untreated dental sites at screening.
- •Other disease of the hard or soft oral tissues.
- •Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
- •Use of medications that are currently affect salivary flow.
- •Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #
- •Pregnant or nursing women.
- •Participation in any other clinical study within 1 week prior to enrollment into this study.
- •Use of tobacco products
- •Subjects who must receive dental treatment during the study dates.
- •Current use of Antibiotics for any purpose.
- •Presence of an orthodontic appliance.
- •History of allergy to common dentifrice ingredients
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- •Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
研究组 & 干预措施
A
control mouthrinse
干预措施: water (Other)
B
new prototype mouthrinse
干预措施: Iodine (Drug)
结局指标
主要结局
Gingival Index
时间窗: 6 weeks
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding
EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale
时间窗: 6 weeks
0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 \& 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.
Plaque Index (Quigley-Hein Score)
时间窗: 6 weeks
Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
次要结局
未报告次要终点