Plaque Induced Gingival Disease
Conditions
Keywords
Triple blind clinical trial, Gingivitis, Hydrogen peroxide, Hyaluronic acid, Chlorhexidine
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.
Interventions
COMBINATION_PRODUCT1-Hydrogen peroxide and hyaluronic acid
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.
COMBINATION_PRODUCT2- Hyaluronic acid
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.
COMBINATION_PRODUCTChlorhexidine
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.
COMBINATION_PRODUCTPlacebo mouthwash
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.
Sponsors
Ramziyah Hayder Bakr
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are randomly assigned to one of four parallel treatment groups, each receiving a different mouthwash intervention for gingivitis management.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Iraq
Outcome results
None listed