Substantivity of Oral Rinses: Comparative Study

Study Overview
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Brief Summary
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A desirable quality of mouthrinses is substantivity an intrinsic feature of some molecules. Substantivity requires the adsorption of the agent on the oral surfaces and subsequently antimicrobial activity bacteriostatic along following hours. This work aims to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.

Detailed Description
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One of the desirable qualities of mouthrinses is substantivity, which is defined as the persistence capacity of its antimicrobial action over time in the mouth. This is an intrinsic feature of some molecules. Such substantivity seems to require the adsorption of the agent on the buccal surfaces and subsequently exert a certain antimicrobial activity that seems to be mostly bacteriostatic. Substantivity is the result of multiple factors controlling or altering adhesion, life period of antimicrobial capabilities, synergisms, antagonisms, and others. In order to improve substantivity and therefore increase antimicrobial effectiveness of CPC, o-Cymen-5-ol has recently been proposed to become incorporated to oral rinses. The aim of this work is to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.

Official Title
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Substantivity of Mouthrinse Formulations Containing Cetylpyridinium Chloride and O-cymen-5-Ol Compared to Placebo on Salivary Microbiota

Conditions
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Prevention & Control

Intervention / Treatment
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* Other: Oral rinse
* Other: Saliva harvest


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: adult age (>18 y/o) good oral helath status minimum 24 evaluable teeth periodontal pockets ≤3 mm absence of caries & periodontal haemorrage Exclusion Criteria: smokers prosthesis or orthodontic devices Sjögren syndrome Antibiotic treatment in the last three months Systemic disease with alteration in the production and/or composition of the saliva

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized, double-blind, crossover study of the in situ antibacterial efficacy of o-Cymen-5-ol plus CPC, o-Cymen-5-ol and CPC on salivary microbiota.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo oral rinse<br>Placebo comparator Volume Time Active molecule 15 mL 1 min No | Other: Oral rinse<br>* Participants use mouthwasher for a given time.<br>Other: Saliva harvest<br>* Non-stimulated saliva harvesting<br>|
| Active Comparator: CPC oral rinse<br>Volume Time Active molecule 15 mL 1 min CPC containing oral rinse | Other: Oral rinse<br>* Participants use mouthwasher for a given time.<br>Other: Saliva harvest<br>* Non-stimulated saliva harvesting<br>|
| Active Comparator: Cymenol oral rinse<br>Volume Time Active molecule 15 mL 1 min Cymenol containing oral rinse | Other: Oral rinse<br>* Participants use mouthwasher for a given time.<br>Other: Saliva harvest<br>* Non-stimulated saliva harvesting<br>|
| Active Comparator: CPC + Cymenol oral rinse<br>Volume Time Active molecule 15 mL 1 min CPC+cymenol containing oral rinse | Other: Oral rinse<br>* Participants use mouthwasher for a given time.<br>Other: Saliva harvest<br>* Non-stimulated saliva harvesting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary experiments | Measure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead) | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substantivity of mouthrinse formulations containing Cetylpyridinium Chloride and O-cymen-5-Ol (single and combined) compared to Placebo on salivary microbiota | Measure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead) rinses plus placebo | up to three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mouth rinses, substanticity, oral infections, salivary microbiota