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Substantivity of Oral Rinses: Comparative Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05365737
Acronym
SORCOS
Enrollment
16
Registered
2022-05-09
Start date
2022-01-01
Completion date
2022-02-03
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention & Control

Keywords

Mouth rinses, substanticity, oral infections, salivary microbiota

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.

Interventions

Participants use mouthwasher for a given time.

OTHERSaliva harvest

Non-stimulated saliva harvesting

Sponsors

University of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Preliminary experimentsone monthMeasure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead)

Secondary

MeasureTime frameDescription
Substantivity of mouthrinse formulations containing Cetylpyridinium Chloride and O-cymen-5-Ol (single and combined) compared to Placebo on salivary microbiotaup to three monthsMeasure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead) rinses plus placebo

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026