A Phase 3 interventional study of resveratrol mouthwash and Chlorhexidine mouthwash (0.2%) in Halitosis, Mouth Disease and Plaque Induced Gingival Disease, sponsored by Al-Mustansiriyah University. Recruiting at 1 site in Iraq. Open to participants aged 20 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Al-Mustansiriyah University · Phase 3, Interventional, and Treatment
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:
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,
the participants will be subjected to organoleptic measurement to detect the patient with halitosis .
The methods used for Organoleptic measurements were done as follows:
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.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's planned enrollment of 54 is above the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →Al-Mustansiriyah University is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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 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 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)
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%
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
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
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: Baseline (Day 0) and after 7 days
Plan to share: No — For Privacy concerns, Ethical considerations, Data security and control over data
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Resveratrol
Al-Mustansiriyah University