A Randomized, Comparative Study to Evaluate the Effect of RL3014A-DP0421 Mouthwash on the Oral Microbial Composition

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

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.

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.

Selection

Criteria related to the population:

• Subject female aged between 18 to 35 years included

• Subject having signed his/her written informed consent for his/her participation in the study

• Subject affiliated to a social security system or health insurance, or is a beneficiary (if required by national regula-tions)

• 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 contraception)
  • Accept to go on using it during the whole duration of the study

• having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization

• certifying the truth of the personal information declared to the Investigator

• able to understand the language used in the investigation center and the information given

• able to comply with the protocol and follow protocol's constraints and specific requirements

Criteria related to subject's health:

- considered "healthy subject" by the Investigator

Criteria related to subject's oral health:

• Subject with a healthy gum status according to the investigator
• Subject with at least 20 natural teeth specially tooth 12, 16, 24, 36, 32 and 44 (If one of these teeth is missing, it will be replaced by a similar natural tooth (i.e. replacement of a molar by another molar) on the same jaw)
• Subjects with no edentulous

Non-selection criteria

Criteria related to the population:

• Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in writing in his/her diary
• 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
• 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 within the previous weeks or months in another clinical study liable to interfere with the study assessments according to the investigator's assessment
• Subject is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician,…), of the investigational site
• Smoker subject (cigarettes and/or user of electronic cigarette)

Criteria related to the medical history / teeth condition:

• Subject with history of hypersensitivity or allergy or intolerance to any of the study products ingredients
• Subject with history of hypersensitivity or allergy or intolerance to any material used for the research
• Subject with active teeth decay
• 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
• Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease
• Subject having occlusal overload or occlusal adjustment recently made on teeth
• 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
• Subject with an odontological condition (like xerostomia,..), an acute chronic or progressive disease or history of disease 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 or with the quantity and quality of saliva according to the investigator assessment within 2 months before 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 2 months before the selection visit or planned during the study
• Subject having modified his/her hygiene or care habits in the mouth (including modification of the use of toothpaste and/ or toothbrush and/or mouthwash) within 7 days before the selection visit
• 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 ( within 48 hours before the selection visit or planned during the study
• Subject planning to have any dental care during the study
• Any other previous/concomitant treatment or product considered by the investigator liable to interfere with the study data or incompatible with the study requirements or hazardous for the subject

Inclusion criteria

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