MouthwashPhase 3NCT07393802
Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Re-Growth
A Phase 3 study testing Resveratrol-Based Mouthwash and Chlorhexidine Gluconate 0.12 % Mouthwash in people with Mouthwash and Chlorhexidine, run by University of Baghdad at 1 site in Iraq.
Trial summary
Dental plaque is a biofilm that accumulates on tooth surfaces and is a primary factor in the development of gingival inflammation. While toothbrushing remains the main method for plaque control, the effectiveness of mechanical oral hygiene depends largely on individual compliance and technique. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouthwash, Chlorhexidine, Biofilm Formation
- What is being tested?
- Resveratrol-Based Mouthwash and Chlorhexidine Gluconate 0.12 % Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- Mar 2026to May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 30 years
- Systemically healthy individuals
- Presence of at least 20 natural teeth
- Clinically healthy gingiva with no signs of gingivitis or periodontitis
- No probing depth >3 mm
- No clinical attachment loss
Who cannot join
- Presence of gingivitis or periodontitis
- Active dental caries requiring treatment
- History of periodontal therapy within the previous 6 months
- Use of antibiotics, anti-inflammatory drugs, or antiseptic mouthwashes within the previous 3 months
- Smoking or tobacco use
- Pregnancy or lactation
- Known allergy to any mouthwash components
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Ahmed Hashim
Karbala
Ahmed Hashim alyasari, master degree, 07731873348 ext. +9640, ahmed.khudhair@uokerbala.edu.iq
About this study
Official title: Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Biofilm Re-Growth Randomized Crossover Clinical Trial
Dental plaque is a biofilm that accumulates on tooth surfaces and is a primary factor in the development of gingival inflammation. While toothbrushing remains the main method for plaque control, the effectiveness of mechanical oral hygiene depends largely on individual compliance and technique. As a result, mouthwashes are commonly used as adjunctive chemical plaque control agents.
Chlorhexidine gluconate is an effective anti-plaque mouthwash, but its use is associated with undesirable effects that may limit patient acceptance. Resveratrol is a naturally derived compound with reported antimicrobial and anti-biofilm properties, suggesting its potential use as an alternative chemical plaque control agent.
This randomized, double-blind, placebo-controlled, three-period crossover clinical trial aims to evaluate the short-term anti-plaque effect of a resveratrol-based mouthwash by measuring supragingival plaque regrowth over a 24-hour period in periodontally healthy individuals. The effects of the resveratrol-based mouthwash will be compared with 0.12% chlorhexidine (CHX) and a placebo mouthwash under standardized conditions without mechanical oral hygiene
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, three-period crossover clinical trial conducted in periodontally healthy individuals to evaluate the short-term anti-plaque efficacy of a resveratrol-based mouthwash. The study population will consist of systemically healthy undergraduate dental students with clinically healthy gingiva and no signs of gingivitis or periodontitis. This population was selected to allow accurate assessment of supragingival plaque re-growth without the influence of periodontal inflammation or periodontal pocketing.
Prior to the clinical trial, participants will undergo a one-week preparatory period during which oral hygiene instructions will be provided and professional scaling and polishing will be performed to obtain plaque-free tooth surfaces. Standardized oral hygiene aids will be supplied for use during the preparatory and washout periods.
Participants will be randomly assigned to different intervention sequences determining the order of the three mouthwashes using a computer-generated randomization list prepared by an independent individual not involved in the clinical examinations. To minimize bias, the study will be conducted in a double-blind manner, with the test, positive control, and placebo mouthwashes dispensed in identical opaque bottles. Both participants and the examiner will remain blinded to the identity of the interventions until completion of all study phases.
At the beginning of each intervention period, supragingival plaque will be disclosed and removed by professional polishing to standardize baseline conditions. Participants will then rinse with 10 milliliters of the assigned mouthwash for 30 seconds under supervision and will be instructed to refrain from eating or drinking for 30 minutes. A second rinse will be performed after 12 hours. Participants will be instructed to refrain from all mechanical oral hygiene measures and the use of additional oral hygiene products during the 24-hour experimental period.
After 24 hours, supragingival plaque accumulation will be assessed using the Modified Quigley-Hein Plaque Index (MQHPI). Digital plaque image analysis (DPIA) will be performed using fluorescein-disclosed ultraviolet images to quantify plaque-covered tooth surfaces. Following plaque assessment, professional polishing will be carried out.
Each intervention phase will be separated by a six-day washout period to minimize potential carryover effects. During the washout period, participants will resume routine oral hygiene practices using standardized oral hygiene aids. The short-term safety and acceptability of the tested mouthwashes will be assessed throughout the study
- Conditions
- Mouthwash, Chlorhexidine, Biofilm Formation, Periodontal Health
- Being tested
- Resveratrol-Based Mouthwash, Chlorhexidine Gluconate 0.12 % Mouthwash, Placebo mouthwash
- Keywords
- Resveratrol, mouthwash, anti-plaque, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol-Based MouthwashDrug
This intervention represents the test group of the study and consists of a resveratrol-based mouthwash (Oroxil®), a patented formulation containing resveratrol and carvacrol. The mouthwash is evaluated as a chemical plaque control agent to assess its short-term anti-plaque efficacy using a 24-hour supragingival plaque re-growth model. The intervention is administered under controlled clinical conditions and compared with chlorhexidine and placebo mouthwashes within a randomized, double-blind, crossover study design.
Chlorhexidine Gluconate 0.12 % MouthwashDrug
This intervention represents the positive control group of the study and involves the use of a 0.12% chlorhexidine digluconate mouthwash. The mouthwash is employed as a reference chemical plaque control agent to evaluate its short-term anti-plaque effect using a 24-hour supragingival plaque biofilm re-growth model. The intervention is administered under standardized and controlled clinical conditions and is compared with the resveratrol-based mouthwash and a placebo within a randomized, double-blind, three-period crossover study design.
Placebo mouthwashDrug
This intervention represents the negative control group of the study and involves the use of a placebo mouthwash with no active antimicrobial ingredients. The placebo is used to assess supragingival plaque biofilm re-growth under standardized conditions and to provide a baseline comparison for evaluating the short-term anti-plaque effects of the resveratrol-based and chlorhexidine mouthwashes. The intervention is administered under controlled clinical conditions within a randomized, double-blind, three-period crossover study design.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol-Based Mouthwash | Experimental | Participants assigned to this arm will rinse with 10 mL of the resveratrol-based mouthwash for 30 seconds. Following rinsing, participants will be instructed to refrain from eating or drinking for at least 30 minutes.
The mouthwash will be used twice daily (at baseline and after 12 hours). During the 24-hour plaque re-growth period, participants will be instructed to avoid all forms of mechanical oral hygiene, including toothbrushing, flossing, and the use of any additional oral hygiene products. Receives: Drug: Resveratrol-Based Mouthwash |
| Chlorhexidine Mouthwash (0.12%) | Active comparator | Participants assigned to this arm will rinse with 10 mL of 0.12% chlorhexidine digluconate mouthwash for 30 seconds. After rinsing, participants will be instructed to refrain from eating or drinking for at least 30 minutes.
The mouthwash will be used twice daily (at baseline and after 12 hours). Throughout the 24-hour plaque re-growth period, participants will be instructed to avoid all mechanical oral hygiene measures, including toothbrushing, flossing, and the use of any additional plaque control products. Receives: Drug: Chlorhexidine Gluconate 0.12 % Mouthwash |
| Placebo mouthwash | Placebo comparator | Participants assigned to this arm will rinse with 10 mL of a placebo mouthwash for 30 seconds. After rinsing, participants will be instructed to refrain from eating or drinking for at least 30 minutes.
The mouthwash will be used twice daily (at baseline and after 12 hours). During the 24-hour plaque re-growth period, participants will be instructed to avoid all mechanical oral hygiene measures, including toothbrushing, flossing, and the use of any additional oral hygiene products. Receives: Drug: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supragingival Plaque Accumulation Assessed by the Modified Quigley-Hein Plaque Index (MQHPI)
Supragingival plaque accumulation will be assessed after 24 hours using the MQHPI. Plaque scores will be recorded for each participant and used to compare plaque accumulation between the different mouthwash interventions.
Measured: 24 hours
Secondary outcomes (3)
Percentage of Plaque-Covered Tooth Surface Assessed by Digital Plaque Image Analysis (DPIA)
Plaque coverage will be assessed after 24 hours using the DPIA. Fluorescein-disclosed plaque images will be obtained, and the percentage of plaque-covered tooth surface will be calculated by dividing the number of pixels classified as plaque on teeth by the total number of pixels representing plaque and tooth surfaces, multiplied by 100. The resulting percentage values will be used for comparison between the different mouthwash interventions
Measured: 24 hours
Number of Participants With Oral Adverse Effects Related to Mouthwash Use
The number of participants experiencing treatment-related oral adverse effects, including oral irritation, burning sensation, mucosal changes, or discomfort, will be assessed during and after each 24-hour intervention period based on clinical examination and participant report.
Measured: 24 hours
Participant-Reported Taste Acceptability of the Tested Mouthwashes
Taste acceptability of each mouthwash will be assessed after each 24-hour intervention period using participant self-report.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MouthwashStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hashim Alyasari, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393802
- Sponsor's protocol ID
- 07731873348
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohammed SA, Akram HM. Evaluating the Efficacy of Resveratrol-Containing Mouthwash as an Adjunct Treatment for Periodontitis: A Randomized Clinical Trial. Eur J Dent. 2025 May;19(2):354-365. doi: 10.1055/s-0044-1788686. Epub 2024 Sep 9.
PubMed 39251207Abed Taher NA, Mahmood AA, Hussein HM. Efficacy of a Mouthwash Containing Resveratrol in Reducing Halitosis-related P. gingivalis: A Randomized Triple-blind Trial. Oral Health Prev Dent. 2025 Dec 2;23:793-803. doi: 10.3290/j.ohpd.c_2373.
PubMed 41328922
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Biofilm Re-Growth Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07393802
- Acronym / sponsor ID
- 07731873348
- Conditions
- Mouthwash, Chlorhexidine, Biofilm Formation, Periodontal Health
- Keywords
- Resveratrol, mouthwash, anti-plaque, crossover
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
Dental plaque is a biofilm that accumulates on tooth surfaces and is a primary factor in the development of gingival inflammation. While toothbrushing remains the main method for plaque control, the effectiveness of mechanical oral hygiene depends largely on individual compliance and technique. As a result, mouthwashes are commonly used as adjunctive chemical plaque control agents.
Chlorhexidine gluconate is an effective anti-plaque mouthwash, but its use is associated with undesirable effects that may limit patient acceptance. Resveratrol is a naturally derived compound with reported antimicrobial and anti-biofilm properties, suggesting its potential use as an alternative chemical plaque control agent.
This randomized, double-blind, placebo-controlled, three-period crossover clinical trial aims to evaluate the short-term anti-plaque effect of a resveratrol-based mouthwash by measuring supragingival plaque regrowth over a 24-hour period in periodontally healthy individuals. The effects of the resveratrol-based mouthwash will be compared with 0.12% chlorhexidine (CHX) and a placebo mouthwash under standardized conditions without mechanical oral hygiene
Detailed description
This study is a randomized, double-blind, placebo-controlled, three-period crossover clinical trial conducted in periodontally healthy individuals to evaluate the short-term anti-plaque efficacy of a resveratrol-based mouthwash. The study population will consist of systemically healthy undergraduate dental students with clinically healthy gingiva and no signs of gingivitis or periodontitis. This population was selected to allow accurate assessment of supragingival plaque re-growth without the influence of periodontal inflammation or periodontal pocketing.
Prior to the clinical trial, participants will undergo a one-week preparatory period during which oral hygiene instructions will be provided and professional scaling and polishing will be performed to obtain plaque-free tooth surfaces. Standardized oral hygiene aids will be supplied for use during the preparatory and washout periods.
Participants will be randomly assigned to different intervention sequences determining the order of the three mouthwashes using a computer-generated randomization list prepared by an independent individual not involved in the clinical examinations. To minimize bias, the study will be conducted in a double-blind manner, with the test, positive control, and placebo mouthwashes dispensed in identical opaque bottles. Both participants and the examiner will remain blinded to the identity of the interventions until completion of all study phases.
At the beginning of each intervention period, supragingival plaque will be disclosed and removed by professional polishing to standardize baseline conditions. Participants will then rinse with 10 milliliters of the assigned mouthwash for 30 seconds under supervision and will be instructed to refrain from eating or drinking for 30 minutes. A second rinse will be performed after 12 hours. Participants will be instructed to refrain from all mechanical oral hygiene measures and the use of additional oral hygiene products during the 24-hour experimental period.
After 24 hours, supragingival plaque accumulation will be assessed using the Modified Quigley-Hein Plaque Index (MQHPI). Digital plaque image analysis (DPIA) will be performed using fluorescein-disclosed ultraviolet images to quantify plaque-covered tooth surfaces. Following plaque assessment, professional polishing will be carried out.
Each intervention phase will be separated by a six-day washout period to minimize potential carryover effects. During the washout period, participants will resume routine oral hygiene practices using standardized oral hygiene aids. The short-term safety and acceptability of the tested mouthwashes will be assessed throughout the study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resveratrol-Based Mouthwash | Experimental | Drug: Resveratrol-Based MouthwashParticipants assigned to this arm will rinse with 10 mL of the resveratrol-based mouthwash for 30 seconds. Following rinsing, participants will be instructed to refrain from eating or drinking for at least 30 minutes. The mouthwash will be used twice daily (at baseline and after 12 hours). During the 24-hour plaque re-growth period, participants will be instructed to avoid all forms of mechanical oral hygiene, including toothbrushing, flossing, and the use of any additional oral hygiene products. |
| Chlorhexidine Mouthwash (0.12%) | Active comparator | Drug: Chlorhexidine Gluconate 0.12 % MouthwashParticipants assigned to this arm will rinse with 10 mL of 0.12% chlorhexidine digluconate mouthwash for 30 seconds. After rinsing, participants will be instructed to refrain from eating or drinking for at least 30 minutes. The mouthwash will be used twice daily (at baseline and after 12 hours). Throughout the 24-hour plaque re-growth period, participants will be instructed to avoid all mechanical oral hygiene measures, including toothbrushing, flossing, and the use of any additional plaque control products. |
| Placebo mouthwash | Placebo comparator | Drug: Placebo mouthwashParticipants assigned to this arm will rinse with 10 mL of a placebo mouthwash for 30 seconds. After rinsing, participants will be instructed to refrain from eating or drinking for at least 30 minutes. The mouthwash will be used twice daily (at baseline and after 12 hours). During the 24-hour plaque re-growth period, participants will be instructed to avoid all mechanical oral hygiene measures, including toothbrushing, flossing, and the use of any additional oral hygiene products. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 30 years
- Systemically healthy individuals
- Presence of at least 20 natural teeth
- Clinically healthy gingiva with no signs of gingivitis or periodontitis
- No probing depth >3 mm
Key exclusion criteria (7 listed)
- Presence of gingivitis or periodontitis
- Active dental caries requiring treatment
- History of periodontal therapy within the previous 6 months
- Use of antibiotics, anti-inflammatory drugs, or antiseptic mouthwashes within the previous 3 months
- Smoking or tobacco use
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 |
|---|---|---|
| Resveratrol-Based MouthwashThis intervention represents the test group of the study and consists of a resveratrol-based mouthwash (Oroxil®), a patented formulation containing resveratrol and carvacrol. The mouthwash is evaluated as a chemical plaque control agent to assess its short-term anti-plaque efficacy using a 24-hour supragingival plaque re-growth model. The intervention is administered under controlled clinical conditions and compared with chlorhexidine and placebo mouthwashes within a randomized, double-blind, crossover study design. | Drug | Resveratrol-Based Mouthwash |
| Chlorhexidine Gluconate 0.12 % MouthwashThis intervention represents the positive control group of the study and involves the use of a 0.12% chlorhexidine digluconate mouthwash. The mouthwash is employed as a reference chemical plaque control agent to evaluate its short-term anti-plaque effect using a 24-hour supragingival plaque biofilm re-growth model. The intervention is administered under standardized and controlled clinical conditions and is compared with the resveratrol-based mouthwash and a placebo within a randomized, double-blind, three-period crossover study design. | Drug | Chlorhexidine Mouthwash (0.12%) |
| Placebo mouthwashThis intervention represents the negative control group of the study and involves the use of a placebo mouthwash with no active antimicrobial ingredients. The placebo is used to assess supragingival plaque biofilm re-growth under standardized conditions and to provide a baseline comparison for evaluating the short-term anti-plaque effects of the resveratrol-based and chlorhexidine mouthwashes. The intervention is administered under controlled clinical conditions within a randomized, double-blind, three-period crossover study design. | Drug | Placebo mouthwash |
Primary outcome
Supragingival Plaque Accumulation Assessed by the Modified Quigley-Hein Plaque Index (MQHPI)
Time frame: 24 hours
Supragingival plaque accumulation will be assessed after 24 hours using the MQHPI. Plaque scores will be recorded for each participant and used to compare plaque accumulation between the different mouthwash interventions.
3 secondary outcomes
Percentage of Plaque-Covered Tooth Surface Assessed by Digital Plaque Image Analysis (DPIA)
Time frame: 24 hours
Number of Participants With Oral Adverse Effects Related to Mouthwash Use
Time frame: 24 hours
Participant-Reported Taste Acceptability of the Tested Mouthwashes
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 39251207Mohammed SA, Akram HM. Evaluating the Efficacy of Resveratrol-Containing Mouthwash as an Adjunct Treatment for Periodontitis: A Randomized Clinical Trial. Eur J Dent. 2025 May;19(2):354-365. doi: 10.1055/s-0044-1788686. Epub 2024 Sep 9.
- Results publication: PubMed 41328922Abed Taher NA, Mahmood AA, Hussein HM. Efficacy of a Mouthwash Containing Resveratrol in Reducing Halitosis-related P. gingivalis: A Randomized Triple-blind Trial. Oral Health Prev Dent. 2025 Dec 2;23:793-803. doi: 10.3290/j.ohpd.c_2373.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resveratrol-Based Mouthwash and Chlorhexidine Gluconate 0.12 % Mouthwash in people with Mouthwash and Chlorhexidine, run by University of Baghdad 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Feb 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hashim alyasari, master degree (07731873348 ext. +9640, ahmed.khudhair@uokerbala.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supragingival Plaque Accumulation Assessed by the Modified Quigley-Hein Plaque Index (MQHPI) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07393802, which also lists 2 linked publications.
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 6 Feb 2026.