Substantivity of Oral Rinses: Comparative Study

Not Applicable

Completed

• Conditions: Prevention & Control
• Interventions: Other: Oral rinse; Other: Saliva harvest

• Registration Number: NCT05365737
• Lead Sponsor: University of Barcelona

Brief 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.

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 Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-01-25
• Study Completion: 2022-02-03
• Study First Submitted: 2022-02-23
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPC oral rinse	Oral rinse	Volume Time Active molecule 15 mL 1 min CPC containing oral rinse
Cymenol oral rinse	Oral rinse	Volume Time Active molecule 15 mL 1 min Cymenol containing oral rinse
placebo oral rinse	Oral rinse	Placebo comparator Volume Time Active molecule 15 mL 1 min No
placebo oral rinse	Saliva harvest	Placebo comparator Volume Time Active molecule 15 mL 1 min No
CPC oral rinse	Saliva harvest	Volume Time Active molecule 15 mL 1 min CPC containing oral rinse
Cymenol oral rinse	Saliva harvest	Volume Time Active molecule 15 mL 1 min Cymenol containing oral rinse
CPC + Cymenol oral rinse	Oral rinse	Volume Time Active molecule 15 mL 1 min CPC+cymenol containing oral rinse
CPC + Cymenol oral rinse	Saliva harvest	Volume Time Active molecule 15 mL 1 min CPC+cymenol containing oral rinse

Primary Outcome Measures

Name	Time	Method
Preliminary experiments	one month	Measure of surviving bacteria by fluorimetry and confocal microscopy (Live \& dead)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Barcelona. Campus Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain