PeriodontitisEarly Phase 1resveratrolNCT05874882
Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment Periodontitis:
A Early Phase 1 study testing resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients and chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients and chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 12 Dec 2022to Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- The inclusion criteria:
- Participants need to be systemically healthy with age > 18 years old.
- Not taking antibiotic and anti-inflammatory drugs in the last three months.
- At least 20 teeth should be present
- Should have unstable periodontitis (PPD ≥ 5 or BOP at 4mm pocket)
Show all 15Show fewer
- The exclusion criteria:
- Patients wearing fixed prosthesis (crowns, bridges or orthodontic appliances)
- Those with chronic disease, immunocompromised patients, pregnant, on contraceptives or lactating women.
- Those currently using any mouthwash.
- Those on antibiotic therapy and anti-inflammatory medications during the study and in the last 3 months before the study.
- Those having a history of hypersensitivity to any product used in the present study.
- Those who are smokers or alcoholics.
- Those who refuse to participate in the trial.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry
Baghdad, None Selected
hadeel M akram, 07703991957, hadeel.mazin@codental.uobaghdad.edu.iq
About this study
Official title: Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment for Periodontitis:
To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis
Read the detailed description
- Measuring and comparing the efficacy of RV mouth wash in comparison with CHX and placebo mouth wash in improving the clinical periodontal parameters;
- Measuring the salivary cytokines (IL-6) before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
- Measuring the salivary RANKL before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
- Correlate the salivary cytokines IL-6 and salivary RANKL with clinical periodontal parameter and with each other.
- Evaluate the intervention by using Visual analog scale (VAS)- score-based questionnaire will be filled out by each participant at the end of the trial.
- Conditions
- Periodontitis
- Being tested
- resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients, chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients, placebo mouthwash as adjunct to scaling and root planing in periodontitis patients
- Keywords
- mouthwash, periodontitis, resveratrol
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patientsOther
Also called resveratrol mouthwash (oraxil)
patients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month
chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patientsOther
Also called chlorhexidine mouthwash (corsodyl)
patients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month
placebo mouthwash as adjunct to scaling and root planing in periodontitis patientsOther
Also called placebo
patients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | patients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month Receives: Other: placebo mouthwash as adjunct to scaling and root planing in periodontitis patients |
| chlorohexidine mouthwash | Active comparator | patients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month Receives: Other: chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients |
| resveratrol mouthwash | Experimental | patients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month Receives: Other: resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding on probing
bleeding on probing
Measured: at1 month from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start12 Dec 2022
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the study include three groups. one of them is the study group in which the patient will use resveratrol mouthwash as adjunct to scaling, the second group use chlorhexidine mouthwas as adjunct to scaling while the third group will use a placebo. all the participants and the examiner are blinded regarding the type of the mouthwash they will be using
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Mazin Akram, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874882
- Sponsor's protocol ID
- 744622
- Acronym
- resveratrol
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment for Periodontitis:
- ClinicalTrials.gov ID
- NCT05874882
- Acronym / sponsor ID
- resveratrol / 744622
- Conditions
- Periodontitis
- Keywords
- mouthwash, periodontitis, resveratrol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 May 2023 (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.
To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis
Detailed description
- Measuring and comparing the efficacy of RV mouth wash in comparison with CHX and placebo mouth wash in improving the clinical periodontal parameters;
- Measuring the salivary cytokines (IL-6) before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
- Measuring the salivary RANKL before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
- Correlate the salivary cytokines IL-6 and salivary RANKL with clinical periodontal parameter and with each other.
- Evaluate the intervention by using Visual analog scale (VAS)- score-based questionnaire will be filled out by each participant at the end of the trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- the study include three groups. one of them is the study group in which the patient will use resveratrol mouthwash as adjunct to scaling, the second group use chlorhexidine mouthwas as adjunct to scaling while the third group will use a placebo. all the participants and the examiner are blinded regarding the type of the mouthwash they will be using
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: placebo mouthwash as adjunct to scaling and root planing in periodontitis patientspatients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month |
| chlorohexidine mouthwash | Active comparator | Other: chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patientspatients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month |
| resveratrol mouthwash | Experimental | Other: resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patientspatients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- -
- Participants need to be systemically healthy with age > 18 years old.
- Not taking antibiotic and anti-inflammatory drugs in the last three months.
- At least 20 teeth should be present
- Should have unstable periodontitis (PPD ≥ 5 or BOP at 4mm pocket)
Key exclusion criteria (0 listed)
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 mouthwash as adjunct to scaling and root planing in periodontitis patientsAlso: resveratrol mouthwash (oraxil)patients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month | Other | resveratrol mouthwash |
| chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patientsAlso: chlorhexidine mouthwash (corsodyl)patients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month | Other | chlorohexidine mouthwash |
| placebo mouthwash as adjunct to scaling and root planing in periodontitis patientsAlso: placebopatients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month | Other | control |
Primary outcome
bleeding on probing
Time frame: at1 month from the baseline
bleeding on probing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients and chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients in people with Periodontitis, run by University of Baghdad 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 15 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeel MA [hakram], master (07703991957, hadeel.mazin@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding on probing (time frame: at1 month from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2023.