Skip to main content
OpenTrials
Completed

NCT Number: NCT07031388

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plaque Induced Gingival Disease Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

khanzad specialized health centre + Hwler dental center + Azadi dental center + Students of Hawler medical college

Erbil, Kurdistan, 00441, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1-Hydrogen peroxide and hyaluronic acid

Combination Product

Hydrogen Peroxide (1.80%): Acts as an antiseptic agent, releasing oxygen that helps in reducing bacterial load and disrupting biofilms associated with gingivitis.

  • Hyaluronic Acid (0.10%): A naturally occurring polysaccharide known for its anti-inflammatory and tissue-regenerative properties, aiding in the healing of gingival tissues Clinical studies have demonstrated the efficacy of Perhyal in managing gingivitis. In a randomized controlled trial, Perhyal showed a significant reduction in gingival inflammation compared to placebo, with no reported adverse effects over 21 days.

2- Hyaluronic acid

Combination Product

This intervention involves the use of a mouthwash containing hyaluronic acid (0.12%) of high molecular weight, without any additional active agents. Hyaluronic acid is a naturally occurring substance known for its anti-inflammatory and wound-healing properties. It supports gingival tissue regeneration and hydration, which may contribute to reducing signs of gingivitis such as redness, swelling, and bleeding. Participants assigned to this arm will rinse with 10 mL of the solution twice daily for three weeks, following standardized oral hygiene instructions. This arm serves to evaluate the independent therapeutic effect of hyaluronic acid in managing gingival inflammation.

Chlorhexidine

Combination Product

This intervention uses a commercially available chlorhexidine gluconate 0.12% mouthwash, widely recognized for its strong antimicrobial properties. Chlorhexidine is considered a gold-standard agent for chemical plaque control and is effective in reducing bacterial load, gingival inflammation, and bleeding. Participants in this group will rinse with 10 mL of the solution twice daily for three weeks, in addition to maintaining regular oral hygiene practices.

Placebo mouthwash

Combination Product

This placebo mouthwash was specially formulated to visually and sensorially resemble the active mouthwash products without containing any active therapeutic ingredients. It was prepared in the AwaMedica laboratory using 1 liter of distilled water, 98.5% distilled water, 2 mL of glycerin for mild viscosity, 5 mL of vanilla flavoring for taste masking, and 8 mL of brown food coloring to match the appearance of chlorhexidine. The solution was stored in 120 mL opaque brown bottles, each labeled only with the participant number to ensure blinding. Participants will use 10 mL of the placebo rinse twice daily for three weeks, following the same oral hygiene protocol as other groups.

Primary outcomes

  1. Change in Gingival Index (GI) from baseline to week 3

    Time frame: 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).

  2. Change in Plaque Index (PI) from baseline to week 3

    Time frame: 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).

  3. Change in Bleeding on Probing (BOP) from baseline to week 3

    Time frame: baseline, week 1, week 2, week 3

    Percentage of sites showing bleeding on probing, recorded within 30 seconds after probing. Range: 0% to 100%.

Secondary outcomes

  1. Change in Discomfort score after mouthwash use

    Time frame: 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.

  2. Change in taste perception after mouthwash use

    Time frame: 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)

  3. Change in tooth color shade assessed by VITA easy shade LITE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ramziyah Hayder Bakr

Other

Registry information

Official study title

Effectiveness of HydrogenPeroxie, Hyaluronic Acid, Chlorhexidine Mouthwashes in Gingivitis Management: A Randomized, Triple-Blind, Controlled Clinical Trial

Acronym: TRIPLE-G

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.