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NCT Number: NCT07393802

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

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

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Resveratrol-Based Mouthwash

Drug

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 % Mouthwash

Drug

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 Mouthwash

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Hashim alyasari, master degree

CONTACT

[email protected]

07731873348 ext. +9640

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Biofilm Re-Growth Randomized Crossover Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 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.

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