NCT07685782已完成不适用
A Randomized, Comparative Study to Evaluate the Effect of a RL3014A-DP0421 Mouthwash Containing Antiplaque Active Ingredient O-cymen-5-ol on the Oral Microbial Composition
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2024年2月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Microbiome evaluation of the saliva
研究概览
简要总结
The Laboratoires Pierre Fabre has on the market a product range of daily use mouthwash, all containing 0.05% of O-Cymen -5-ol, a broad-spectrum bactericide. From other mouth rinses (reference mouthwash) it is known that they have a clear effect on the microbial composition of the tongue and saliva samples. RL3014A - DP0421, is the product of the range with the most representative formula.
The aim of the study is to evaluate if the product RL3014A - DP0421 respects the buccal flora and does not show an undesired effect on the microbial equilibrium of the mouth.
详细描述
This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.
Study population: Adults with healthy gum status included and randomized in 4 parallel groups:
- Group 1 (Tested group). Group with standardized hygiene and applying the tested mouthwash (RL3014A - DP0421).
- Group 2 (Positive control group). Group with standardized hygiene and applying the positive control mouthwash.
- Group 3 (Reference group). Group with standardized hygiene and applying the reference mouthwash.
- Group 4 (Negative control group). Group with standardized hygiene only
4 visits are planned:
- Visit 1: Screening (Day -14 ± 1 day).
- Visit 2: Inclusion (Day 0).
- Visit 3: Intermediate (Day 14 ± 1 day).
- Visit 4: End of study (Day 28 ± 1 day).
The maximal duration of subject's participation is 44 days from the selection visit (visit 1) to the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Criteria related to the population:
- •For woman of childbearing potential:
- •Use of an effective method of contraception, as assessed by the investigator for at least 1 month before the selection visit (3 months in case of hormonal con-traception)
- •Accept to go on using it during the whole duration of the study
- •Subject having been compliant to the toothpaste and toothbrush use according to the investigator and still willing to follow it
- •Criteria related to the teeth condition:
- •Subject still having a healthy gum status according to the investigator
- •Subject still having at least 20 natural teeth specially tooth 12, 16, 24, 36, 32 and 44
- •Subject still not edentulous
- •Criteria related to the products:
- •- Subject whose performed his/her last teeth brushing either the evening before the inclusion visit (if the inclusion visit is performed in the morning) or in the morning of the inclusion visit (if the inclusion visit is performed in the afternoon).
- •Non-inclusion criteria
- •Criteria related to the population:
- •For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
- •Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship since the selection visit
- •Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
- •Subject who is currently participating, who plans to participate or who has participated since the selection visit in another clinical study liable to interfere with the study assessments according to the investigator's assessment
- •Introduction of smoking habits (cigarettes and/or user of electronic cigarette) since the selection visit
- •Subject having eaten or drunk alcohol, tea or coffee within 4 hours prior to the inclusion visit
- •Criteria related to the medical history / teeth condition:
- •Subject with hypersensitivity or allergy or intolerance to any of the study products ingredients since the selection visit
- •Subject with hypersensitivity or allergy or intolerance to any material used for the research since the selection visit
- •Subject with active teeth decay since the selection visit
- •Subject with missing teeth since the selection visit
- •Subject with teeth showing evidence of facets of attrition, premature contact, cracked enamel in the mouth liable to interfere with study data according to the investigator since the selection visit
- •Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease since the selection visit
- •Subject having occlusal overload or occlusal adjustment recently made on teeth since the selection visit
- •Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator, especially herpes or medical history herpes, aphtous and medical history of aphtous, lichen planus, chronic lupus erythematosis, sores or mouth ulcer since the selection visit
- •Subject with an odontological condition (like xerostomia,..), an acute chronic or progressive disease or history of disease since the selection visit considered by the investigator hazardous for the subject or incompatible with the study (like immune system disorder, asthma crisis…),
- •Criteria related to treatments and/or products:
- •Surgery, chemical or physical treatment in the mouth liable to interfere with study data according to the investigator assessment since the selection visit or planned during the study
- •Systemic or topical antibiotics in the mouth liable to interfere with study data according to the investigator assessment within since the selection visit or planned during the study
- •Systemic treatment/product or topical treatment/product in the mouth liable to interfere with study data according to the investigator assessment, especially: acetylsalicylic acid or derivatives, anti-inflammatories and other analgesic, antihistaminics, corticosteroids, immunosuppressants, calcic inhibitors and anticonvulsants since the selection visit or planned during the study
- •Subject having had a dental care since the selection visit or planned during the study
- •Any other concomitant treatment or product considered by the investigator liable to in-terfere with the study data or incompatible with the study requirements or hazardous for the subject taken or applied since the selection visit
- •Subject having use another toothpaste and/or toothbrush than study products since the selection visit
- •Subject having use a mouthwash since the selection visit
排除标准
- 未提供
结局指标
主要结局
Microbiome evaluation of the saliva
时间窗: Visit 2 (Day 0) and Visit 4 (Day 28)
Liquid saliva sampling
Microbiome evaluation of the back of the tongue
时间窗: Visit 2 (Day 0) and Visit 4 (Day 28)
Tongue swab sampling (cotton-swab samples)
Proteomic analysis of saliva
时间窗: Visit 2 (Day 0) and Visit 4 (Day28)
Liquid saliva sampling
次要结局
- Plaque index (TQHIP) score(Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28))
- Modified Gingival index of Lobene(Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28))
- Recording of adverse events(From Visit 1 (Day 1) to Visit 4 (Day 28 or early termination))
研究者
研究点 (1)
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