Plaque Induced Gingival DiseaseTRIPLE-GNCT07031388
Mouthwashes for Gingivitis: Comparing a Hydrogen Peroxide-Hyaluronic Acid Mix, Hyaluronic Acid, and Chlorhexidine, A Triple-Blind Clinical Trial
A study testing 1-Hydrogen peroxide and hyaluronic acid, 2- Hyaluronic acid and Chlorhexidine in people with Plaque Induced Gingival Disease, run by Ramziyah Hayder Bakr at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingival Disease
- What is being tested?
- 1-Hydrogen peroxide and hyaluronic acid, 2- Hyaluronic acid and Chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Current use of any mouthwash.
- Smoking habit.
- Presence of active caries.
- Overhanging restorations and crowns.
- Presence of supra- or subgingival calculus.
- Ongoing orthodontic treatment (including post-treatment retainer)
Show all 13Show fewer
- 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.
- Periodontal probing depth >3 mm. Periodontal screening was performed with a periodontal probe (Medesy®, Italy); participants with probing depths > 3 mm were excluded.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
khanzad specialized health centre + Hwler dental center + Azadi dental center + Students of Hawler medical college
Erbil, Kurdistan, 00441
About this study
Official title: Effectiveness of HydrogenPeroxie, Hyaluronic Acid, Chlorhexidine Mouthwashes in Gingivitis Management: A Randomized, Triple-Blind, Controlled 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.
Read the 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.
- Conditions
- Plaque Induced Gingival Disease
- Being tested
- 1-Hydrogen peroxide and hyaluronic acid, 2- Hyaluronic acid, Chlorhexidine, Placebo mouthwash
- Keywords
- Triple blind clinical trial, Gingivitis, Hydrogen peroxide, Hyaluronic acid, Chlorhexidine
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Hydrogen peroxide and hyaluronic acidCombination 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 acidCombination 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.
ChlorhexidineCombination 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 mouthwashCombination 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 140 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.
| Study group | Role | What they receive |
|---|---|---|
| 1- Arm 1 Hydrogen peroxide + Hyaluronic acid | Experimental | Participants in this arm will receive a mouthwash formulation containing 1.8% hydrogen peroxide and 0.10% hyaluronic acid. The mouthwash is to be used twice daily for 3 weeks, following standardized oral hygiene instructions. This combination is intended to synergize the antimicrobial effects of hydrogen peroxide with the anti-inflammatory and healing properties of hyaluronic acid to manage gingivitis. Receives: Combination Product: 1-Hydrogen peroxide and hyaluronic acid |
| 2- Arm 2 Hyaluronic acid alone | Experimental | Participants in this arm will use a mouthwash containing 0.12% high molecular weight hyaluronic acid only. The mouthwash will be used twice daily for 3 weeks. Hyaluronic acid is known for its anti-inflammatory, tissue repair, and moisturizing effects, and this arm will assess its standalone effectiveness in improving gingival health in patients with gingivitis. Receives: Combination Product: 2- Hyaluronic acid |
| 3- Arm 3 chlorhexidine (CHX) | Experimental | Participants in this arm will receive a commercially available mouthwash containing 0.12% chlorhexidine gluconate. The solution will be used twice daily for 3 weeks, following standardized oral hygiene instructions. Chlorhexidine is a widely used antiseptic known for its broad-spectrum antimicrobial activity and effectiveness in reducing plaque and gingival inflammation. Receives: Combination Product: Chlorhexidine |
| 4- Arm 4 placebo | Placebo comparator | Participants in this arm will receive a placebo mouthwash designed to closely mimic the active treatments in appearance, taste, and viscosity, ensuring effective blinding. The formulation comprises:
* 2 mL glycerin
* Vanilla flavoring agent
* Brown food coloring
* Distilled water to make up 1 liter
This placebo was prepared at Awamedica, a certified Class A pharmaceutical manufacturer known for its state-of-the-art formulation laboratory and commitment to quality in pharmaceutical manufacturing. The solution is dispensed in 140 mL opaque brown bottles, each labeled solely with the participant's number to maintain blinding. Participants are instructed to use the mouthwash twice daily for 3 weeks, following standardized oral hygiene instructions. This arm serves as a negative control to assess the true efficacy of the active mouthwash formulations in managing gingivitis. Receives: Combination Product: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Index (GI) from baseline to week 3
Mean Gingival Index score per participant, assessed at four sites per tooth. Score range: 0 (normal) to 3 (severe inflammation).
Measured: Baseline, Week 1, Week 2, Week 3
Change in Plaque Index (PI) from baseline to week 3
Mean Plaque Index score per participant, assessed using the Silness and Löe method-score range: 0 (no plaque) to 3 (abundant plaque).
Measured: Baseline, week 1, week 2, week 3
Change in Bleeding on Probing (BOP) from baseline to week 3
Percentage of sites showing bleeding on probing on six surfaces, recorded within 30 seconds after probing. Range: 0% to 100%.
Measured: baseline, week 1, week 2, week 3
Secondary outcomes (3)
Change in Discomfort score after mouthwash use
Discomfort will be assessed using a Visual Analog Scale (0 = no discomfort, 10 = extreme discomfort). A higher score indicates worse discomfort.
Measured: After 3 weeks of mouthwash use
Change in taste perception after 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)
Measured: After 3 weeks of mouthwash use
Change in tooth color shade assessed by VITA easy shade LITE
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.
Measured: At baseline and after 3 weeks of mouthwash use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Sep 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced Gingival DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of four parallel treatment groups, each receiving a different mouthwash intervention for gingivitis management.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramziyah Hayder Bakr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ramziyah Hayder Bakr, Kurdistan Higher Council of Medical Specialties
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031388
- Sponsor's protocol ID
- RP-DPH-KHCMS-2025-001
- Acronym
- TRIPLE-G
- Status last verified
- Sep 2026
- First submitted
- 28 May 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing has not been confirmed at this stage. It depends on future institutional decisions and ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of HydrogenPeroxie, Hyaluronic Acid, Chlorhexidine Mouthwashes in Gingivitis Management: A Randomized, Triple-Blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07031388
- Acronym / sponsor ID
- TRIPLE-G / RP-DPH-KHCMS-2025-001
- Conditions
- Plaque Induced Gingival Disease
- Keywords
- Triple blind clinical trial, Gingivitis, Hydrogen peroxide, Hyaluronic acid, Chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ramziyah Hayder BakrUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are randomly assigned to one of four parallel treatment groups, each receiving a different mouthwash intervention for gingivitis management.
| Arm | Type | Receives |
|---|---|---|
| 1- Arm 1 Hydrogen peroxide + Hyaluronic acid | Experimental | Combination Product: 1-Hydrogen peroxide and hyaluronic acidParticipants in this arm will receive a mouthwash formulation containing 1.8% hydrogen peroxide and 0.10% hyaluronic acid. The mouthwash is to be used twice daily for 3 weeks, following standardized oral hygiene instructions. This combination is intended to synergize the antimicrobial effects of hydrogen peroxide with the anti-inflammatory and healing properties of hyaluronic acid to manage gingivitis. |
| 2- Arm 2 Hyaluronic acid alone | Experimental | Combination Product: 2- Hyaluronic acidParticipants in this arm will use a mouthwash containing 0.12% high molecular weight hyaluronic acid only. The mouthwash will be used twice daily for 3 weeks. Hyaluronic acid is known for its anti-inflammatory, tissue repair, and moisturizing effects, and this arm will assess its standalone effectiveness in improving gingival health in patients with gingivitis. |
| 3- Arm 3 chlorhexidine (CHX) | Experimental | Combination Product: ChlorhexidineParticipants in this arm will receive a commercially available mouthwash containing 0.12% chlorhexidine gluconate. The solution will be used twice daily for 3 weeks, following standardized oral hygiene instructions. Chlorhexidine is a widely used antiseptic known for its broad-spectrum antimicrobial activity and effectiveness in reducing plaque and gingival inflammation. |
| 4- Arm 4 placebo | Placebo comparator | Combination Product: Placebo mouthwashParticipants in this arm will receive a placebo mouthwash designed to closely mimic the active treatments in appearance, taste, and viscosity, ensuring effective blinding. The formulation comprises: * 2 mL glycerin * Vanilla flavoring agent * Brown food coloring * Distilled water to make up 1 liter This placebo was prepared at Awamedica, a certified Class A pharmaceutical manufacturer known for its state-of-the-art formulation laboratory and commitment to quality in pharmaceutical manufacturing. The solution is dispensed in 140 mL opaque brown bottles, each labeled solely with the participant's number to maintain blinding. Participants are instructed to use the mouthwash twice daily for 3 weeks, following standardized oral hygiene instructions. This arm serves as a negative control to assess the true efficacy of the active mouthwash formulations in managing gingivitis. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Current use of any mouthwash.
- Smoking habit.
- Presence of active caries.
- Overhanging restorations and crowns.
- Presence of supra- or subgingival calculus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Hydrogen peroxide and hyaluronic acidHydrogen 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 product | 1- Arm 1 Hydrogen peroxide + Hyaluronic acid |
| 2- Hyaluronic acidThis 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 product | 2- Arm 2 Hyaluronic acid alone |
| ChlorhexidineThis 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 product | 3- Arm 3 chlorhexidine (CHX) |
| Placebo mouthwashThis 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 140 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. | Combination product | 4- Arm 4 placebo |
Primary outcome
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 at four sites per tooth. Score range: 0 (normal) to 3 (severe inflammation).
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).
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 on six surfaces, recorded within 30 seconds after probing. Range: 0% to 100%.
3 secondary outcomes
Change in Discomfort score after mouthwash use
Time frame: After 3 weeks of mouthwash use
Change in taste perception after mouthwash use
Time frame: After 3 weeks of mouthwash use
Change in tooth color shade assessed by VITA easy shade LITE
Time frame: At baseline and after 3 weeks of mouthwash use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data sharing has not been confirmed at this stage. It depends on future institutional decisions and ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Hydrogen peroxide and hyaluronic acid, 2- Hyaluronic acid and Chlorhexidine in people with Plaque Induced Gingival Disease, run by Ramziyah Hayder Bakr at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Index (GI) from baseline to week 3 (time frame: Baseline, Week 1, Week 2, Week 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.