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

ConditionsMouthwashChlorhexidineBiofilm FormationPeriodontal Health
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Baghdad

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Resveratrol-Based MouthwashExperimental treatment 1 intervention
Group B: Chlorhexidine Mouthwash (0.12%)Active comparator 1 intervention
Group C: Placebo mouthwashPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

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

Time frame
24 hours
2

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.

Time frame
24 hours
3

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.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov

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