Substantivity of Oral Rinses: Comparative Study (SORCOS)

University of Barcelona

Status: Completed

Conditions: Prevention & Control

Treatments: Other: Oral rinse; Other: Saliva harvest

Study type: Interventional

Funder types: Other

Identifiers

NCT05365737

33/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups, including a placebo group

placebo oral rinse

Placebo Comparator group

Description:

Placebo comparator Volume Time Active molecule 15 mL 1 min No

Treatment:

Other: Saliva harvest

Other: Oral rinse

CPC oral rinse

Active Comparator group

Description:

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

Treatment:

Other: Saliva harvest

Other: Oral rinse

Cymenol oral rinse

Active Comparator group

Description:

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

Treatment:

Other: Saliva harvest

Other: Oral rinse

CPC + Cymenol oral rinse

Active Comparator group

Description:

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

Treatment:

Other: Saliva harvest

Other: Oral rinse