Substantivity of Oral Rinses: Comparative Study (SORCOS)
Substantivity of Mouthrinse Formulations Containing Cetylpyridinium Chloride and O-cymen-5-Ol Compared to Placebo on Salivary Microbiota
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Barcelona
-
Hospitalet de Llobregat, Barcelona, Spain, 08907
- University of Barcelona. Campus Bellvitge
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo oral rinse
Placebo comparator Volume Time Active molecule 15 mL 1 min No
|
Participants use mouthwasher for a given time.
Non-stimulated saliva harvesting
|
|
Active Comparator: CPC oral rinse
Volume Time Active molecule 15 mL 1 min CPC containing oral rinse
|
Participants use mouthwasher for a given time.
Non-stimulated saliva harvesting
|
|
Active Comparator: Cymenol oral rinse
Volume Time Active molecule 15 mL 1 min Cymenol containing oral rinse
|
Participants use mouthwasher for a given time.
Non-stimulated saliva harvesting
|
|
Active Comparator: CPC + Cymenol oral rinse
Volume Time Active molecule 15 mL 1 min CPC+cymenol containing oral rinse
|
Participants use mouthwasher for a given time.
Non-stimulated saliva harvesting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preliminary experiments
Time Frame: one month
|
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
Time Frame: up to three months
|
Measure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead) rinses plus placebo
|
up to three months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Miguel Viñas, PhD, University of Barcelona-Spain-
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 33/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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