Clinical Study to Evaluate the Efficacy of a Regimen Including Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and Brushing and a Regimen Including Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Modified Gingival Index
研究概览
简要总结
This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and to rising with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. One hundred and twenty participants, aged between 18 and 65 years, will be included and followed for 12 weeks.
详细描述
This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and brushing and to a regimen including a rinsing with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, randomized, one-center, parallel group, double blinded, involving 120 participants, aged 18 to 65. Subjects will be allocated into 3 groups: one - using the CPC+Zn mouthwash, another using the essential oils mouthwash and a control group using dental floss. Each group will also use a fluoride toothpaste and a soft-bristle toothbrush twice daily over 12 weeks. The primary efficacy variable is the reduction of gingival inflammation also Probing Depth, Bleeding on Probing, and a Plaque Index will be accessed. Subjects will undergo baseline, 4-week, and 12-week evaluations, with data analyzed using ANCOVA to assess the efficacy and safety of the products. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of these oral hygiene regimens.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking involves several key roles to ensure unbiased results and to maintain the integrity of the study results. The Participant, Care Provider, Investigator, and Outcomes Assessor are all masked in this double-blind study. The participants do not know which group they have been assigned to, the care providers administering the treatments are unaware of the specific products being used by each participant, the investigators conducting the study do not know the group assignments, and the outcomes assessors evaluating the results are blind to the treatment allocations.
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
- 否
入选标准
- •Availability for the duration of the study;
- •Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
- •Willingness to provide information related to their medical history;
- •≥20 teeth with scorable facial and lingual surfaces; evidence of gingivitis;
- •≥10 bleeding sites based on the Bleeding Index (BI);
- •Initial mean gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index (MGI);
- •Subjects without allergies to the products that are being tested;
- •Informed Consent Form signed.
排除标准
- •no sites with >5 mm probing depth, and a maximum of three sites of 5 mm probing depth.
- •Have received dental prophylaxis within 1 month prior to the Baseline visit;
- •Need for antibiotics prior to dental treatment; use of antibiotics, anti-inflammatory or anticoagulant therapy during the three months prior to entry into the study;
- •Usage of oral care products containing chemotherapeutic products within 2 weeks prior to Baseline;
- •Use of smokeless tobacco;
- •Any other condition that would make the volunteer inappropriate for the study.
- •Oral pathology, chronic disease, or a history of allergy to testing products;
- •Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- •Subject participating in any other clinical study;
- •Subject pregnant or breastfeeding;
- •Subject allergic to oral care products, personal care consumer products, or their ingredients;
- •Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- •Periodontal treatment 12 months before the beginning of the study;
- •Current smokers and subjects with a history of alcohol or drug abuse;
- •Subjects with orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations
研究组 & 干预措施
CPC+Zn mouthwash and brushing
A regimen composing of a CPC+Zn mouthwash, brushing with a commercially available toothbrush and a stannous fluoride-based toothpaste
干预措施: Mouthwash CPC+Zn+F (Drug)
Essential oils mouthwash and brushing
A regimen composing of an essential oils mouthwash, brushing with a commercially available toothbrush and a fluoride-based toothpaste
干预措施: Essential oils mouthwash (Drug)
Flossing and brushing
A regimen composing of flossing and brushing with a commercially available toothbrush and a fluoride-based toothpaste
干预措施: Dental floss (Device)
结局指标
主要结局
Modified Gingival Index
时间窗: 12 weeks
The Modified Gingival Index (MGI) is used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health/inflammation on a scale from 0 to 4, where 0 signifies normal gingiva with no inflammation, and 4 indicates severe inflammation characterized by erythema, edema, and spontaneous bleeding.
次要结局
- Turesky modification of Quigley-Hein Plaque Index(12 weeks)
- Bleeding on probing(12 weeks)
- Probing depth(12 weeks)