Clinical trial NCT05365737: Substantivity of Oral Rinses: Comparative Study
Official title: Substantivity of Mouthrinse Formulations Containing Cetylpyridinium Chloride and O-cymen-5-Ol Compared to Placebo on Salivary Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention & Control
Keywords: Mouth rinses
substanticity
oral infections
salivary microbiota
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preliminary experiments
timeFrame: one month
Secondary outcomes:
measure: Substantivity of mouthrinse formulations containing Cetylpyridinium Chloride and O-cymen-5-Ol (single and combined) compared to Placebo on salivary microbiota
timeFrame: up to three months
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: University of Barcelona. Campus Bellvitge
state: Barcelona
Study officials:
affiliation: University of Barcelona-Spain-
name: Miguel Viñas, PhD
role: STUDY_CHAIR
References: