Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyrymonas Gingivalis.

NCT06882564 | Recruiting Phase 3

• 1 other identifier: MUOSU-202124
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study: To assess the efficacy of antioxidant (resveratrol) mouthwash in reducing the level of p. gingivitis and oral malodor over 7 day period among undergraduate dental student patients from Mustansiriyah University/College of Dentistry and Wasit University /College of Dentistry. Objectives:

• To assess the efficacy of anti-oxidant and anti-inflammatory resveratrol mouthwash in reducing halitosis in undergraduate students with plaque-induced gingivitis patients.
• To assess the efficacy of resveratrol mouthwash in reducing p. gingivalis in undergraduate students' patients with oral malodor.
• To determine the relation between p.gingivalis and clinical periodontal parameters (plaque index, gingival index, bleeding on probing) among undergraduate students with plaque-induced gingivitis and halitosis.

Conditions

Halitosis; Mouth Disease; Plaque Induced Gingival Disease; Bleeding Gum; Peridontal Disease

Keywords

halitosis; plaque; gingivitis; resveratrol; chlorhexidine

Outcome Measures

Primary Outcomes (5)

• change in oral halitosis (oral malodor)

  change in volatile sulfur compounds(VSCs) levels measured by organoleptic method and portable monitor( Halimeter), change in p.gingivalis count using real-time PCR. the participants will be subjected to organoleptic measurement to detect the patient with halitosis according to organoleptic categories. A portable sulfide monitor will be use to confirm the result of organoleptic method, a

  Baseline (Day 0) and after 7 days

• change in clinical periodontal parameters ( gingival index)

  GI will be measured by using Löe and Silness index, each of the four gingival areas of the tooth is given a score from 0 to 3 as follows: 0 Normal gingiva, 1. Mild inflammation slight change in color, slight oedema 2. Moderate inflammation-redness, oedema and glazing. 3. Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding s

  Baseline (Day 0) and after 7 days

• change in clinical periodontal parameters (plaque index)

  The plaque index will be measured by using the O'Leary plaque index. By recording the presence of plaque on (mesial, distal, facial, lingual) surfaces, A disclosing solution will painted on all exposed tooth surfaces at the initial appointment. The examiner will use an explorer or probe tip to examine all the stained surface for dental biofilm. After all teeth were examined and scored, the mean was calculated by dividing the number of plaque surfaces by the total number of available surfaces multiplied by 100%. (O'Leary et al., 1972).

  Baseline (Day 0) and after 7 days

• change in clinical periodontal parameters (bleeding on probing)

  Bleeding on Probing will be measured by gently inserting the periodontal probe at the six surfaces of all teeth to the depth of the gingival sulcus then removed coronally and waited for 30 seconds to observe the presence or absence of bleeding (0=no bleeding, 1=presence of bleeding). (Newman MG., 2011)

  Baseline (Day 0) and after 7 days

• change in p.gingivalis level

  DNA extraction and purification of p. gingivalis from plaque sample will be performed by using Real-time PCR amplification for each sample using primers specific for p. gingivalis . Bacterial ribosomal RNA (rRNA) primers Will be used to quantify total bacteria both before and after intervention.

  Baseline (Day 0) and after 7 days

Study Arms (3)

Resveratrol group ( group A )

EXPERIMENTAL

The participants in this group will receive a resveratrol mouthwash for 7 days, the participants were instructed to rinse twice daily (every 12hours) with 10 ml of the assigned mouthwash (undiluted) for 30 seconds, after 30 minutes of toothbrushing. They will also be provided with measuring cups with 10 ml marking in order to use the correct volume of mouthwash. They were also instructed to refrain from eating and drinking for 30 minutes after rinsing with no change to their routine mechanical dental home care (brushing and interdental aids cleaning). The patients were also informed that burning sensation and bitterness were also expected after rinsing. Discontinuation of the mouthwash was advised in case of any allergic reaction.

Drug: resveratrol mouthwash

Chlorhexidine group ( group B)

ACTIVE COMPARATOR

the participants in this group will receive Chlorhexidine mouthwash for 7 days. they were instructed to rinse twice daily (every 12 hours) with 10 ml of the assigned mouthwash (undiluted) for 30 seconds, after 30 minutes of toothbrushing. They will also be provided with measuring cups with 10 ml markings to use the correct volume of mouthwash. They were also instructed to refrain from eating and drinking for 30 minutes after rinsing with no change to their routine mechanical dental home care (brushing and interdental aid cleaning). The patients were also informed that burning sensations and bitterness were expected after rinsing. Discontinuation of the mouthwash was advised in case of an allergic reaction.

Drug: Chlorhexidine mouthwash (0.2%)

placebo group ( group C)

PLACEBO COMPARATOR

the participants in this group will receive a distilled water as amouthwash for 7 days. the participants were instructed to rinse twice daily (every 12 hours) with 10 ml of the assigned mouthwash (undiluted) for 30 seconds, after 30 minutes of toothbrushing. They will also be provided with measuring cups with 15 ml markings to use the correct volume of mouthwash. They were also instructed to refrain from eating and drinking for 30 minutes after rinsing with no change to their routine mechanical dental home care (brushing and interdental aid cleaning). The patients were also informed that burning sensations and bitterness were expected after rinsing. Discontinuation of the mouthwash was advised in case of an allergic reaction.

Drug: Placebo

Interventions

resveratrol mouthwash DRUG

the participants where instruct to rinse their mouth twice daily with 10 ml of assigned mouthwash for 60 seconds for 7 days. There is currently no published research on the use of resveratrol as a mouthwash for halitosis treatment. This study aims to fill this gap by evaluating its effectiveness in reducing oral malodor through antibacterial action and the potential of volatile sulfur compounds ( VSCs)

Resveratrol group ( group A )

Chlorhexidine mouthwash (0.2%) DRUG

The second group will given chlorhexidine 0.2% mouthwash as an active comparator, and will asked to rinse with 10 ml of undiluted mouthwash for 60 seconds twice per day for 7 days, and will instructed to refrain from eating and drinking for 30 min after rinsing.

Also known as: chlorhexidine 0.2%

Chlorhexidine group ( group B)

Placebo DRUG

the third group will given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 seconds twice daily for 7 days and will be instructed to refrain from eating and drinking for 30 min after rinsing.

Also known as: placebo product

placebo group ( group C)

Eligibility Criteria

• Age: 20 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Organoleptic tongue of scores \> 2 using (0-5scale) (Rosenberg and McCulloch, 1992)
• Male and female undergraduate dental students without chemical plaque control measures for at least one weak
• Male and female students with halitosis due to gingivitis
• The age of students ranges from 20 to 23 years.
• No periodontal treatment for at least one month
• No systemic disease
• No tobacco smoking
• The patients must have at least 20 teeth

You may not qualify if:

• Smokers and alcoholics
• Patient with periodontitis or pocket depth \> 6mm
• Patient with orthodontics appliance
• Open carious lesions, pericoronitis, dry socket, and fistula.
• Patients with systemic disease and condition
• taking medication in the last two weeks
• Take garlic, onion, or licorice in the last 24 hours
• using oral hygiene products in the last 24 hours
• pregnant women
• sinusitis, tonsilitis, and upper respiratory tract infection

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Mustansiriyah University

Baghdad, Bab Al-Moadham, 10047, Iraq

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Halitosis; Mouth Diseases; Gingival Hemorrhage; Plaque, Amyloid; Gingivitis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomatognathic Diseases; Oral Hemorrhage; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Anatomical; Infections

Study Officials

• NOOR AA TAHER, B.D.S

  Al-Mustansiriyah University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NOOR AA TAHER, B.D.S

CONTACT

07803432060 Ext. +964; noor-aliabed@uomustansiriyah.edu.iq

NOOR AA TAHER, B.D.S

CONTACT

07803432060, Ext +964; noor-aliabed@uomustansiriyah.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 letter that in turn will refer to the type of product. the association between the letter and the type of product will be collected by another operator .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Model Details: 54 students with halitosis du to gingivitis and interdental plaque accumulation will divided blindly to three groups, each group consisting from 18 patients; The first group will receive anti-oxidant resveratrol mouthwash The second group will receive chlorhexidine mouthwash (positive control group) The third group will receive Distilled water commercially available a placebo mouthwash

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: January 5, 2025
• Primary Completion: April 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)