HalitosisPhase 3NCT06882564
Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyrymonas Gingivalis.
A Phase 3 study testing resveratrol mouthwash and Chlorhexidine mouthwash (0.2%) in people with Halitosis and Mouth Disease, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis, Mouth Disease, Plaque Induced Gingival Disease
- What is being tested?
- resveratrol mouthwash and Chlorhexidine mouthwash (0.2%)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIraq
- Study dates
- 5 Jan 2025to 1 Nov 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
Mustansiriyah University
Baghdad, Bab Al-Moadham, 10047
NOOR AA TAHER, B.D.S, 07803432060 Ext +967, noor-aliabed@uomustansiriyah.edu.iq
NOOR AA TAHER, B.D.S
About this study
Official title: 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.
Read more
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.
Read the 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,
- 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. the participants will be subjected to organoleptic measurement to detect the patient with halitosis .
The methods used for Organoleptic measurements were done as follows:
- 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).
- 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.
- Conditions
- Halitosis, Mouth Disease, Plaque Induced Gingival Disease, Bleeding Gum, Peridontal Disease
- Being tested
- resveratrol mouthwash, Chlorhexidine mouthwash (0.2%), Placebo
- Keywords
- halitosis, plaque, gingivitis, resveratrol, chlorhexidine
- Medical subject headings
- Halitosis, Mouth Diseases, Gingival Hemorrhage, Plaque, Amyloid, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrol mouthwashDrug
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)
Chlorhexidine mouthwash (0.2%)Drug
Also called chlorhexidine 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.
PlaceboDrug
Also called placebo product
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Baseline (Day 0) and after 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start5 Jan 2025
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Ali Abdul, Al-Mustansiriyah University
- Investigators
- NOOR AA TAHER, B.D.S, Principal investigator, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882564
- Sponsor's protocol ID
- MUOSU-202124
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For Privacy concerns, Ethical considerations, Data security and control over data
Publications
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.
PubMed 41328922
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyromonas Gingivalis: A Randomized, Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06882564
- Acronym / sponsor ID
- MUOSU-202124
- Conditions
- Halitosis, Mouth Disease, Plaque Induced Gingival Disease, Bleeding Gum, Peridontal Disease
- Keywords
- halitosis, plaque, gingivitis, resveratrol, chlorhexidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
- 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. the participants will be subjected to organoleptic measurement to detect the patient with halitosis .
The methods used for Organoleptic measurements were done as follows:
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Resveratrol group ( group A ) | Experimental | Drug: resveratrol mouthwashThe 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. |
| Chlorhexidine group ( group B) | Active comparator | Drug: Chlorhexidine mouthwash (0.2%)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. |
| placebo group ( group C) | Placebo comparator | Drug: Placebothe 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. |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resveratrol mouthwashthe 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) | Drug | Resveratrol group ( group A ) |
| Chlorhexidine mouthwash (0.2%)Also: chlorhexidine 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. | Drug | Chlorhexidine group ( group B) |
| PlaceboAlso: placebo productthe 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. | Drug | placebo group ( group C) |
Primary outcome
change in oral halitosis (oral malodor)
Time frame: Baseline (Day 0) and after 7 days
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
change in clinical periodontal parameters ( gingival index)
Time frame: Baseline (Day 0) and after 7 days
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
change in clinical periodontal parameters (plaque index)
Time frame: Baseline (Day 0) and after 7 days
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).
change in clinical periodontal parameters (bleeding on probing)
Time frame: Baseline (Day 0) and after 7 days
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)
change in p.gingivalis level
Time frame: Baseline (Day 0) and after 7 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 41328922Abed 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.
- Individual participant dataSharing planned: No. For Privacy concerns, Ethical considerations, Data security and control over data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NOOR AA TAHER, B.D.S principal investigator
Al-Mustansiriyah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing resveratrol mouthwash and Chlorhexidine mouthwash (0.2%) in people with Halitosis and Mouth Disease, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NOOR AA TAHER, B.D.S (07803432060 Ext. +964, noor-aliabed@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in oral halitosis (oral malodor) (time frame: Baseline (Day 0) and after 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.