Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Re-Growth

January 30, 2026 updated by: Ahmed Hashim Alyasari, University of Baghdad

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol-Based Mouthwash

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.
Drug: Resveratrol-Based Mouthwash
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.
Active Comparator: Chlorhexidine Mouthwash (0.12%)

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.
Drug: Chlorhexidine Gluconate 0.12 % Mouthwash
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 Comparator: Placebo mouthwash

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.
Drug: Placebo mouthwash
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Plaque-Covered Tooth Surface Assessed by Digital Plaque Image Analysis (DPIA)
Time Frame: 24 hours
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
24 hours
Number of Participants With Oral Adverse Effects Related to Mouthwash Use
Time Frame: 24 hours
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.
24 hours
Participant-Reported Taste Acceptability of the Tested Mouthwashes
Time Frame: 24 hours
Taste acceptability of each mouthwash will be assessed after each 24-hour intervention period using participant self-report.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07731873348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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