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

May 15, 2023 updated by: Hadeel Mazin Akram, University of Baghdad

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding on probing
Time Frame: at1 month from the baseline
bleeding on probing
at1 month from the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 744622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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