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Completed

NCT Number: NCT05365737

Substantivity of Oral Rinses: Comparative Study

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Barcelona. Campus Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult age (>18 y/o)
  • good oral helath status
  • minimum 24 evaluable teeth
  • periodontal pockets ≤3 mm
  • absence of caries & periodontal haemorrage

Exclusion criteria

  • smokers
  • prosthesis or orthodontic devices
  • Sjögren syndrome
  • Antibiotic treatment in the last three months
  • Systemic disease with alteration in the production and/or composition of the saliva

Treatment and study plan

Oral rinse

Other

Participants use mouthwasher for a given time.

Saliva harvest

Other

Non-stimulated saliva harvesting

Primary outcomes

  1. Preliminary experiments

    Time frame: one month

    Measure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead)

Secondary outcomes

  1. Substantivity of mouthrinse formulations containing Cetylpyridinium Chloride and O-cymen-5-Ol (single and combined) compared to Placebo on salivary microbiota

    Time frame: up to three months

    Measure of surviving bacteria by fluorimetry and confocal microscopy (Live & dead) rinses plus placebo

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

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

Acronym: SORCOS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 9, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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