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

Periodontitis Clinical Trial

— resveratrol  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874882
• Other study ID #: 744622
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 12, 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of Baghdad
• Contact: Hadeel MA [hakram], master
• Phone: 07703991957
• Email: hadeel.mazin[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Periodontitis

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Iraq	College of Dentistry	Baghdad	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding on probing	bleeding on probing	at1 month from the baseline