MedTrace Logo

Chlorhexidine (CHX) Mouthwash With or Without an Anti-Discoloration System (ADS) During Experimental Gingivitis

NCT07696364 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-08-12

No results posted yet for this study

Summary

Recently, a chlorhexidine product with an anti-discoloration system (ADS) was launched in the market. A comparative study was done to confirm the effectiveness of 0.2% chlorhexidine with ADS. The study was single-blinded. In the experimental period, volunteers maintained their usual oral hygiene habits, besides, they rinsed twice daily with mouthwash (0.2% chlorhexidine) with or without ADS. Obviously, subject's home oral hygiene may become a major confounder of plaque accumulation. Although the effect of ADS is statistically significant, the ability of this new product to prevent plaque accumulation and gingivitis remained highly questionable.

Hence, controversy exists about the clinical efficacy of the chlorhexidine products with ADS. Consequently, a clinical validation of such products appears necessary. In the present study, the 21-day experimental gingivitis model will be used. This model is an established non-invasive model in humans for investigating the induction and resolution of inflammation in response to increasing bacterial accumulation. The design enables a study to be performed over 35 days in a well-controlled manner. So far, it is the most accurate clinical study model to access how medication or compounds in dentifrices affect plaque accumulation and gingival inflammation.

Conditions

  • Gingivitis Infection

Interventions

OTHER

Experimental gingivitis model

Participants will abolish all measures for mechanical plaque control for a period of 3 weeks according to the experimental gingivitis model.

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2026-09-07
Completion
2027-08-07

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696364 on ClinicalTrials.gov