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

Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyromonas Gingivalis: A Randomized, Triple-blind Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Halitosis; Mouth Disease; Bleeding Gum; Peridontal Disease; Plaque Induced Gingival Disease
• Intervention / Treatment: Drug: resveratrol mouthwash; Drug: Chlorhexidine mouthwash (0.2%); Drug: Placebo

Detailed Description

54 students with halitosis due to gingivitis and interdental plaque accumulation will divided into three groups, each group consisting of 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 as a placebo mouthwash To enhance self-dosing compliance, each participant was contacted each morning and night by text message to remind them to use the mouthwash.

All participants will be subjected to a questionnaire about their name, age, past periodontal treatment, medical history, the medication used, smoking, use of dental brush and interdental aids, and frequency of brushing, the participants will be subjected to another questionnaire about their knowledge, attitude and behaviors about oral malodor, Then (Gingival index, bleeding on probing and plaque index will record clinically All these records will be measured again after one week of using mouthwash twice daily. Finally, the participants filled out a visual analog scale-based assessment questionnaire to obtain feedback on each mouthwash used.

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 surfaces 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).

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 removing coronally and waiting for 30 seconds to observe the presence or absence of bleeding (0=no bleeding, 1=presence of bleeding). (Newman MG., 2011).

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.

the participants will be subjected to organoleptic measurement to detect the patient with halitosis .

The methods used for Organoleptic measurements were done as follows:

1. Tongue odor test: used to determine the halitosis originating from the dorsum of the tongue. A sterile cotton roll was used to scrape the posterior dorsum of the tongue and after 5 seconds the odor is assessed by holding it 5 cm away from the nose (Bosy et al., 1994).
2. Dental floss odor test: used to determine the halitosis originating from the interdental areas. Dental floss pick was passed into the interdental regions of all the teeth by instantly inserting and removing manner and the floss odor is assessed by holding it about 3 cm away from the nose (Ongole and Shenoy, 2010).

A portable sulfide monitor will be use to confirm the result of organoleptic method, a clinical parameter to be measured in logic sequence will include gingival and plaque index. The periodontal examination will be performed by using a periodontal probe.

Randomization and blinding In order to ensure blinding of both participants and the examiner, the mouthwashes will be dispensed into identical opaque bottles measuring 300 ml and each mouthwash group will assign a random sequential letter (A, B, C) and decoding will perform at the end of the study. Microsoft excel (Microsoft Office 2016, Microsoft Corporation, USA) was used to generate random numbers that will be used to resort the order of the mouthwash groups (A, B, C) (N=54) so that each group will receive equal number of participants (N=18) with 1:1:1 allocation. Then, the coded bottles with the mouthwashes were given to the participants together with instructions of use.

All the participants were instructed to rinse twice daily (every 12hours) with 15 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: NOOR AA TAHER, B.D.S; Phone Number: 07803432060 Ext. +964; Email: noor-aliabed@uomustansiriyah.edu.iq
• Study Contact Backup: Name: NOOR AA TAHER, B.D.S; Phone Number: 07803432060, Ext +964; Email: noor-aliabed@uomustansiriyah.edu.iq

Study Locations

• Iraq
  • Bab Al-Moadham
    • Baghdad, Bab Al-Moadham, Iraq, 10047
      • Recruiting
      • Mustansiriyah University
      • Contact: NOOR AA TAHER, B.D.S; Phone Number: 07803432060 Ext +967; Email: noor-aliabed@uomustansiriyah.edu.iq
      • Principal Investigator: NOOR AA TAHER, B.D.S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resveratrol group ( group A ); 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; 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)
Active Comparator: Chlorhexidine group ( group B); 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%); 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.; Other Names: chlorhexidine 0.2%
Placebo Comparator: placebo group ( group C); 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; 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.; Other Names: placebo product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,; Mild inflammation slight change in color, slight oedema; Moderate inflammation-redness, oedema and glazing.; 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

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University
• Investigators: Principal Investigator: NOOR AA TAHER, B.D.S, Al-Mustansiriyah University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: chlorhexidine; gingivitis; plaque; resveratrol; halitosis
• Additional Relevant MeSH Terms: Periodontal Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Gingival Diseases; Mouth Diseases; Halitosis; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Platelet Aggregation Inhibitors; Antioxidants; Protective Agents; Anti-Infective Agents, Local; Disinfectants; Resveratrol; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: MUOSU-202124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For Privacy concerns, Ethical considerations, Data security and control over data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No