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

Early Phase 1

Recruiting

• Conditions: Periodontitis
• Interventions: Other: chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients; Other: resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients; Other: placebo mouthwash as adjunct to scaling and root planing in periodontitis patients

• Registration Number: NCT05874882
• Lead Sponsor: University of Baghdad

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.

Study Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2023-04-27
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chlorohexidine mouthwash	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
resveratrol mouthwash	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
control	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

Primary Outcome Measures

Name	Time	Method
bleeding on probing	at1 month from the baseline	bleeding on probing

Trial Locations

Locations (1)

College of Dentistry; 🇮🇶 Baghdad, None Selected, Iraq