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resveratrol: Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment Periodontitis:

Sponsor
University of Baghdad (Other)
Overall Status
Recruiting
CT.gov ID
NCT05874882
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
11.6
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis

Condition or Disease Intervention/Treatment Phase
  • Other: resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients
  • Other: chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients
  • Other: placebo mouthwash as adjunct to scaling and root planing in periodontitis patients
 Early Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 usingthe 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
the supervisor will place the mouthwash in dark bottle with number so neither the examiner nor the patient will know the type of the mouthwash
Primary Purpose:
Supportive Care
Official Title:
Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment for Periodontitis:
Actual Study Start Date :
Dec 12, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: control

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

Other: placebo mouthwash as adjunct to scaling and root planing in periodontitis patients
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
Other Names:
  • placebo

    		•
    Active Comparator: chlorohexidine mouthwash

    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: chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients
    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 Names:
  • chlorhexidine mouthwash (corsodyl)

    		•
    Experimental: resveratrol mouthwash

    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 as adjunct to scaling and root planing in periodontitis patients
    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 Names:
  • resveratrol mouthwash (oraxil)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. bleeding on probing [at1 month from the baseline]

      bleeding on probing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    The inclusion criteria:

    1. Participants need to be systemically healthy with age > 18 years old.

    2. Not taking antibiotic and anti-inflammatory drugs in the last three months.

    3. At least 20 teeth should be present

    4. Should have unstable periodontitis (PPD ≥ 5 or BOP at 4mm pocket)

    The exclusion criteria:

    1. Patients wearing fixed prosthesis (crowns, bridges or orthodontic appliances)

    2. Those with chronic disease, immunocompromised patients, pregnant, on contraceptives or lactating women.

    3. Those currently using any mouthwash.

    4. Those on antibiotic therapy and anti-inflammatory medications during the study and in the last 3 months before the study.

    5. Those having a history of hypersensitivity to any product used in the present study.

    6. Those who are smokers or alcoholics.

    7. Those who refuse to participate in the trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 College of Dentistry Baghdad None Selected Iraq

    Sponsors and Collaborators

    • University of Baghdad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hadeel Mazin Akram, assistant professor, University of Baghdad
    ClinicalTrials.gov Identifier:
    NCT05874882
    Other Study ID Numbers:
    • 744622
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hadeel Mazin Akram, assistant professor, University of Baghdad
    mouthwash
    periodontitis
    resveratrol
    Additional relevant MeSH terms:
    Periodontitis
    Chlorhexidine
    Chlorhexidine gluconate
    Resveratrol

    Study Results

    No Results Posted as of May 25, 2023