Substantivity of Oral Rinses: Comparative Study

NCT05365737 | Completed

• 1 other identifier: 33/2021
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention & Control

Keywords

Mouth rinses; substanticity; oral infections; salivary microbiota

Outcome Measures

Primary Outcomes (1)

• Preliminary experiments

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

  one month

Secondary Outcomes (1)

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

  up to three months

Study Arms (4)

placebo oral rinse

PLACEBO COMPARATOR

Placebo comparator Volume Time Active molecule 15 mL 1 min No

Other: Oral rinse; Other: Saliva harvest

CPC oral rinse

ACTIVE COMPARATOR

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

Other: Oral rinse; Other: Saliva harvest

Cymenol oral rinse

ACTIVE COMPARATOR

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

Other: Oral rinse; Other: Saliva harvest

CPC + Cymenol oral rinse

ACTIVE COMPARATOR

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

Other: Oral rinse; Other: Saliva harvest

Interventions

Oral rinse OTHER

Participants use mouthwasher for a given time.

CPC + Cymenol oral rinse; CPC oral rinse; Cymenol oral rinse; placebo oral rinse

Saliva harvest OTHER

Non-stimulated saliva harvesting

CPC + Cymenol oral rinse; CPC oral rinse; Cymenol oral rinse; placebo oral rinse

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

University of Barcelona. Campus Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• Aguilera FR, Vinas M, Sierra JM, Vinuesa T, R Fernandez de Henestrosa A, Furmanczyk M, Trullas C, Jourdan E, Lopez-Lopez J, Jorba M. Substantivity of mouth-rinse formulations containing cetylpyridinium chloride and O-cymen-5-ol: a randomized-crossover trial. BMC Oral Health. 2022 Dec 27;22(1):646. doi: 10.1186/s12903-022-02688-z.

  PMID: 36575444 DERIVED

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Miguel Viñas, PhD

  University of Barcelona-Spain-

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor Microbiology

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: May 9, 2022
• Study Start: January 1, 2022
• Primary Completion: January 25, 2022
• Study Completion: February 3, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)