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

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Early Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
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
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis focused on measuring mouthwash, periodontitis, resveratrol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - 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) 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. -

Sites / Locations

  • College of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

control

chlorohexidine mouthwash

resveratrol mouthwash

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

bleeding on probing
bleeding on probing

Secondary Outcome Measures

Full Information

First Posted
April 27, 2023
Last Updated
May 15, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05874882
Brief Title
Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment Periodontitis:
Acronym
resveratrol
Official Title
Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment for Periodontitis:
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
mouthwash, periodontitis, resveratrol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
chlorohexidine mouthwash
Arm Type
Active Comparator
Arm Description
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
Arm Title
resveratrol mouthwash
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients
Other Intervention Name(s)
resveratrol mouthwash (oraxil)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients
Other Intervention Name(s)
chlorhexidine mouthwash (corsodyl)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
placebo mouthwash as adjunct to scaling and root planing in periodontitis patients
Other Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
bleeding on probing
Description
bleeding on probing
Time Frame
at1 month from the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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) 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadeel MA [hakram], master
Phone
07703991957
Email
hadeel.mazin@codental.uobaghdad.edu.iq
Facility Information:
Facility Name
College of Dentistry
City
Baghdad
State/Province
None Selected
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hadeel M akram
Phone
07703991957
Email
hadeel.mazin@codental.uobaghdad.edu.iq

12. IPD Sharing Statement

Plan to Share IPD
No

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

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