Substantivity of Oral Rinses: Comparative Study

Prevention & Control Clinical Trial

— SORCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05365737
• Other study ID #: 33/2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: February 3, 2022

Study information

• Verified date: May 2022
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 3, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

1. adult age (>18 y/o)

2. good oral helath status

3. minimum 24 evaluable teeth

4. periodontal pockets =3 mm

5. absence of caries & periodontal haemorrage

Exclusion Criteria:

1. smokers

2. prosthesis or orthodontic devices

3. Sjögren syndrome

4. Antibiotic treatment in the last three months

5. Systemic disease with alteration in the production and/or composition of the saliva

Related Conditions & MeSH terms

• Prevention & Control

Intervention

Other:
• Oral rinse
Participants use mouthwasher for a given time.
• Saliva harvest
Non-stimulated saliva harvesting

Locations

Country	Name	City	State
Spain	University of Barcelona. Campus Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary experiments	Measure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead)	one month
Secondary	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