Mouthwashes for Gingivitis: Comparing a Hydrogen Peroxide-Hyaluronic Acid Mix, Hyaluronic Acid, and Chlorhexidine, A Triple-Blind Clinical Trial

Not Applicable

Active, not recruiting

• Conditions: Plaque Induced Gingival Disease

• Registration Number: NCT07031388
• Lead Sponsor: Ramziyah Hayder Bakr

Brief Summary

This randomized, triple-blind clinical trial is designed to evaluate the efficacy of four different mouthwash formulations - hydrogen peroxide with hyaluronic acid, hyaluronic acid alone, chlorhexidine, and placebo - in four parallel arms. The study will take place at multiple centers, starting on June 1, 2025, and is expected to conclude by October 1, 2026. There is no external funding source for this study.

Eligible participants include systemically healthy individuals aged 18 to 35 years with a gingival and plaque index score of 1 or higher. Individuals with systemic or oral diseases will be excluded. Participants will be randomly assigned to one of four groups, each receiving a different mouthwash formulation for twice-daily use, following standardized oral hygiene instructions.

The potential benefit includes a reduced risk of gingivitis progression to periodontitis. There are no significant anticipated risks, though mild oral discomfort or taste alteration may occur.

Detailed Description

This randomized, triple-blind clinical trial aims to compare the effectiveness and safety of four different mouthwash formulations in managing gingivitis. The test group will use a mouthwash containing hydrogen peroxide (H2O2 1.80% )and hyaluronic acid (HA 0.10%). The three comparator groups will receive either chlorhexidine (CHX 0.12%), hyaluronic acid (HA 0.12%) (high molecular weight) alone, or a placebo mouthwash.

A total of four parallel arms will be used. Participants will be randomly assigned using a computer-generated randomization list. Blinding will apply to participants, clinical evaluators, and data analysts to maintain objectivity (triple-blind design).

Each participant will use the assigned mouthwash twice daily for three weeks, following standard oral hygiene instructions.

The primary outcomes will be changes in gingival inflammation, plaque accumulation, and bleeding on probing, assessed using the Gingival Index (GI), Plaque Index (PI), and Bleeding on Probing (BOP). Measurements will be taken at baseline, and after one, two, and three weeks of intervention.

The secondary outcomes will include reported side effects such as taste alteration, tooth discoloration, and overall comfort using the mouthwash.

The study is designed to determine which formulation offers the best balance of clinical effectiveness and patient acceptability in gingivitis management.

Study Timeline

• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-22
• Study Start: 2025-07-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-27
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subjects with a gingival index score of 1 or greater.
• Subjects with a plaque index score of 1 or greater
• Systemically healthy individuals.
• Minimum of 20 natural teeth

Exclusion Criteria

• Current use of any mouthwash.
• Smoking habit.
• Presence of active caries.
• Overhanged restorations and crowns.
• Presence of supra or subgingival calculus.
• Ongoing orthodontic treatment (including post-treatment retainer)
• Periodontal treatment within the past 6 months and a diagnosis of periodontitis.
• Use of antibiotics within the past 4 months or requirement for antibiotic prophylaxis.
• Systematic or topical non-steroidal anti-inflammatory drug treatment for the past 4 months
• Pregnancy or lactation.
• History of heart valve replacement.
• Known intolerance or allergy to mouth rinses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Plaque Index (PI) from baseline to week 3	Baseline, week 1, week 2, week 3	Mean Plaque Index score per participant, assessed using the Silness and Löe method-score range: 0 (no plaque) to 3 (abundant plaque).
Change in Bleeding on Probing (BOP) from baseline to week 3	baseline, week 1, week 2, week 3	Percentage of sites showing bleeding on probing, recorded within 30 seconds after probing. Range: 0% to 100%.
Change in Gingival Index (GI) from baseline to week 3	Baseline, Week 1, Week 2, Week 3	Mean Gingival Index score per participant, assessed on six sites per tooth. Score range: 0 (normal) to 3 (severe inflammation).

Secondary Outcome Measures

Name	Time	Method
Change in Discomfort score after mouthwash use	After 3 weeks of mouthwash use	Discomfort will be assessed using a Visual Analog Scale (0 = no discomfort, 10 = extreme discomfort). A higher score indicates worse discomfort.
Change in taste perception after mouthwash use	After 3 weeks of mouthwash use	Presence or absence of taste change (yes/no); * Type of alteration (metallic, bitter, sweet, sour, salty, other); * Intensity (mild, moderate, severe); * Duration (less than 5 minutes, 5-15 minutes, 15-30 minutes, more than 30 minutes)
Change in tooth color shade assessed by VITA easy shade LITE	At baseline and after 3 weeks of mouthwash use	Tooth color will be assessed at baseline and the end of the study using a VITA shade guide (VITA easy shade LITE). Shade values (e.g., A3, B1, 1L1.5, 2L1.5) will be recorded as observed. Changes will be presented as direct comparisons between baseline and final visit for each participant (e.g., "A3 to B1").; No numerical scale or categorization will be applied. The results will be reported as the exact shade code changes observed using the VITA system.

Trial Locations

Locations (1)

khanzad specialized health centre + Hwler dental center + Azadi dental center + Students of Hawler medical college; 🇮🇶 Erbil, Kurdistan, Iraq