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

NCT07393802 | Not Yet Recruiting Phase 3

• 1 other identifier: 07731873348
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Chlorhexidine; Biofilm Formation; Periodontal Health; Mouthwash

Keywords

Resveratrol; mouthwash; anti-plaque; crossover

Outcome Measures

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.

  24 hours

Secondary Outcomes (3)

• Percentage of Plaque-Covered Tooth Surface Assessed by Digital Plaque Image Analysis (DPIA)

  24 hours

• Number of Participants With Oral Adverse Effects Related to Mouthwash Use

  24 hours

• Participant-Reported Taste Acceptability of the Tested Mouthwashes

  24 hours

Study Arms (3)

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.

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.

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.

Drug: Placebo mouthwash

Interventions

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.

Placebo mouthwash

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.

Resveratrol-Based Mouthwash

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.

Chlorhexidine Mouthwash (0.12%)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Ahmed Hashim

Karbala, Iraq

Location

Related Publications (2)

• 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.

  PMID: 39251207 RESULT

• Abed 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.

  PMID: 41328922 RESULT

MeSH Terms

Interventions

chlorhexidine gluconate; Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Ahmed Hashim alyasari, master degree

CONTACT

07731873348; ahmed.khudhair@uokerbala.edu.iq

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of periodontology

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)