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

NCT05874882 | Unknown Early Phase 1

• 1 other identifier: 744622
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

Keywords

mouthwash; periodontitis; resveratrol

Outcome Measures

Primary Outcomes (1)

• bleeding on probing

  bleeding on probing

  at1 month from the baseline

Study Arms (3)

control

PLACEBO COMPARATOR

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

chlorohexidine mouthwash

ACTIVE COMPARATOR

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

resveratrol mouthwash

EXPERIMENTAL

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

Interventions

resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients OTHER

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

Also known as: resveratrol mouthwash (oraxil)

resveratrol mouthwash

chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients OTHER

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

Also known as: chlorhexidine mouthwash (corsodyl)

chlorohexidine mouthwash

placebo mouthwash as adjunct to scaling and root planing in periodontitis patients OTHER

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

Also known as: placebo

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry

Baghdad, None Selected, Iraq

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Root Planing; Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Hadeel MA [hakram], master

CONTACT

07703991957; hadeel.mazin@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 25, 2023
• Study Start: December 12, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)