Clinical trial NCT06882564: Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyrymonas Gingivalis.
Official title: Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyromonas Gingivalis: A Randomized, Triple-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Halitosis
Mouth Disease
Plaque Induced Gingival Disease
Bleeding Gum
Peridontal Disease
Keywords: halitosis
plaque
gingivitis
resveratrol
chlorhexidine
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in oral halitosis (oral malodor)
timeFrame: Baseline (Day 0) and after 7 days
measure: change in clinical periodontal parameters ( gingival index)
timeFrame: Baseline (Day 0) and after 7 days
measure: change in clinical periodontal parameters (plaque index)
timeFrame: Baseline (Day 0) and after 7 days
measure: change in clinical periodontal parameters (bleeding on probing)
timeFrame: Baseline (Day 0) and after 7 days
measure: change in p.gingivalis level
timeFrame: Baseline (Day 0) and after 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Mustansiriyah University
state: Bab Al-Moadham
Study officials:
affiliation: Al-Mustansiriyah University
name: NOOR AA TAHER, B.D.S
role: PRINCIPAL_INVESTIGATOR
References: