Evaluation of the Anti-septic Effect of a Chlorhexidine (CHX) Mouthwash With or Without an Anti-Discoloration System (ADS) During Experimental Gingivitis

NCT07696364 | Enrolling By Invitation

• 1 other identifier: V4ExpAugGingivitis
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

experimental gingivitis; gingivitis model; mouth-rinses with anti-discoloration system

Outcome Measures

Primary Outcomes (1)

• Severity of gingival inflammation, assessed by the Gingival Index by Löe and Silness 1963

  The index is a scoring system 0, 1, 2, or 3 where 0 is defining normal gingiva to 3 representing severe inflammation with spontaneous bleeding

  at day 21

Secondary Outcomes (6)

• Severity of gingival inflammation, assessed by the Gingival Index by Löe and Silness 1963

  at day 0, 7, 14, and 35

• Plaque accumulation, assessed by the Plaque Index Silness and Löe 1994

  at day 0, 7, 14, 21 and 35

• Staining assessed by the Discoloration index

  at day 0, 7, 14, 21 and 35

• Oral scan

  at day 0, 21 and 35

• Microbiological changes

  at day 0, 21 and 35

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

Group P rinses twice daily with 10 ml of a placebo (pure water with flavored additive) solution

Other: Experimental gingivitis model

Group T1

EXPERIMENTAL

Group T1 rinses twice daily with 10 ml of 0.12% chlorhexidine solution with ADS (Anti-Discoloration System) solution (Curasept ADS 212)

Other: Experimental gingivitis model

Group T2

EXPERIMENTAL

Group T2 rinses twice daily with 10 ml of 0.12% chlorhexidine with HA (Hyaluronic Acid)

Other: Experimental gingivitis model

Interventions

Experimental gingivitis model OTHER

After a preparatory phase of prophylaxis and 3 weeks of optimal oral hygiene practice, the plaque and gingivitis scores of the participants will approach zero. The participants will then be asked to abolish all measures for mechanical plaque control for a period of 3 weeks according to the experimental gingivitis model.

Group T1; Group T2; Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• systemically healthy,
• non-smoker, former smokers \> 5 years,
• at least 24 teeth,
• clinical diagnosis of periodontal health or gingivitis as determined by pocket probing depth not exceeding 4 mm with concomitant bleeding on probing.

You may not qualify if:

• clinically visible carious lesions,
• systemic antibiotics within 3 months prior to enrolment
• vulnerable persons

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology, University of Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization has been performed by the mouth-rinse company by delivering brown bottles of the same size and shape labeled with A, B, and C for the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center, double-blind, parallel, randomized controlled trial (RCT) conducted on 33 volunteers recruited by the University of Berne School of Dental Medicine (aged 18-40 years) with a documented healthy periodontium

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): August 7, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)