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

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.

Study Overview

• Status: Completed
• Conditions: Prevention & Control
• Intervention / Treatment: Other: Oral rinse; Other: Saliva harvest

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: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • University of Barcelona. Campus Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Barcelona
• Investigators: Study Chair: Miguel Viñas, PhD, University of Barcelona-Spain-

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): February 3, 2022

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Mouth rinses; substanticity; oral infections; salivary microbiota
• Other Study ID Numbers: 33/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No