Substantivity of Oral Rinses: Comparative Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-02-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Double-blind, Randomized, Parallel, Placebo-controlled Clinical Study to Evaluate the Viral Load of SARS-CoV-2 (COVID-19) in the Oral Cavity of SARS-CoV-2 Positive Subjects After the Use of a Mouthwash Containing Cetylpyridinium Chloride 0,07%.

NCT04757818

SARS-CoV-2 Infection

COMPLETED NA

Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva

NCT06437262

Healthy Saliva Biofilms

COMPLETED PHASE1

A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases

NCT02756377

Periodontal Diseases

COMPLETED PHASE2/PHASE3

Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.

NCT02194023

Dental Plaque Side Effects

COMPLETED PHASE2

Impact of a Newly Formulated Toothpaste in Tooth Staining Associated With Chlorhexidine Rinses

NCT05354986

Tooth Staining Periodontitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention & Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo oral rinse

Placebo comparator Volume Time Active molecule 15 mL 1 min No

Group Type PLACEBO_COMPARATOR

Oral rinse

Intervention Type OTHER

Participants use mouthwasher for a given time.

Saliva harvest

Intervention Type OTHER

Non-stimulated saliva harvesting

CPC oral rinse

Volume Time Active molecule 15 mL 1 min CPC containing oral rinse

Group Type ACTIVE_COMPARATOR

Oral rinse

Intervention Type OTHER

Participants use mouthwasher for a given time.

Saliva harvest

Intervention Type OTHER

Non-stimulated saliva harvesting

Cymenol oral rinse

Volume Time Active molecule 15 mL 1 min Cymenol containing oral rinse

Group Type ACTIVE_COMPARATOR

Oral rinse

Intervention Type OTHER

Participants use mouthwasher for a given time.

Saliva harvest

Intervention Type OTHER

Non-stimulated saliva harvesting

CPC + Cymenol oral rinse

Volume Time Active molecule 15 mL 1 min CPC+cymenol containing oral rinse

Group Type ACTIVE_COMPARATOR

Oral rinse

Intervention Type OTHER

Participants use mouthwasher for a given time.

Saliva harvest

Intervention Type OTHER

Non-stimulated saliva harvesting

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral rinse

Participants use mouthwasher for a given time.

Intervention Type OTHER

Saliva harvest

Non-stimulated saliva harvesting

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes