Antiplaque and Antigingivitis Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC): a Randomized Clinical Trial with Experimental Gingivitis Model
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Löe-Silness Gingival Index
研究概览
简要总结
This is an experimental gingivitis clinical study to evaluate gum health efficacy from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene regimen with a 3-week follow-up. Thirty participants, aged between 18 and 70, will be enrolled.
详细描述
This is an examiner blind, randomized controlled, parallel designed clinical study that aims to assess the gum health efficacy (antiplaque and antigingivitis) from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene in a 3-week experimental gingivitis. Thirty participants will be enrolled and allocated into 3 groups: group I - using a water flosser device and water each time; group II - using a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time (for groups I an II participants will use this regimen treatment twice daily, in the morning and evening, and no other oral hygiene will be allowed during the 21 days of follow-up); group III - negative control in which participants will abstain for any oral hygiene during the 21 days of follow-up. Gingival index measurements will be the primary efficacy variable after using the assigned regimen for 3 weeks for each subject. Subjects will under go baseline, 3 days, 1, 2 and 3 weeks visits. An Analysis of Covariance will be performed on the final or delta plaque scores using the baseline value as covariate. The F-test in this analysis will test the hypothesis that the waterflosser groups are equal in adjusted means.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form;
- •Aged between 18 and 70;
- •Available for the three (3) week study duration;
- •Good general health for participation in the study, based on the opinion of the study investigator;
- •Must have at least 20 natural permanent teeth;
- •Teeth must meet the scoring entry criteria for dental plaque and gingivitis (gum inflammation) at the discretion of the study examiner.
排除标准
- •Medical condition which requires premedication prior to dental visits/procedures;
- •Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations;
- •Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months;
- •Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care;
- •Abnormalities/diseases of the soft or hard oral tissues;
- •Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
- •Use of drugs that can affect salivary flow;
- •Use of antibiotics three (3) months prior to study entry and/or during participation in this study;
- •Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion;
- •Self-reported pregnancy and/or breastfeeding;
- •Current Participation in another clinical study or during the month prior to this clinical study entry;
- •Known allergies and/or reactions to common dentifrice ingredients;
- •Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- •Immunocompromised conditions (AIDS, immunosuppressive drug therapy);
- •Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
研究组 & 干预措施
Group II: waterflosser + dilutable 0.075% CPC
Subjects assigned to this group will use a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up.
干预措施: oral irrigator (Device)
Group II: waterflosser + dilutable 0.075% CPC
Subjects assigned to this group will use a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up.
干预措施: Cetylpyridinium Chloride (CPC) (Drug)
Group I: water flosser and water
Subjects assigned to this group will use a water flosser device and water each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up.
干预措施: oral irrigator (Device)
结局指标
主要结局
Löe-Silness Gingival Index
时间窗: 3 weeks
A Löe-Silness Gingival Index score from 0 to 3 (0 = absence of inflammation and 3 = severe inflammation) will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth (6 sites/tooth) using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored.
次要结局
- Navy Plaque Index, Rustogi Modification(3 weeks)