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NCT05759416 Clinical Trial

Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:
Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05759416
Other study ID # AADJ-2111-1091
Secondary ID Aadj@azhar.edu.e
Status Completed
Phase Phase 4
First received
Last updated
Start date April 1, 2020
Est. completion date March 1, 2021

Study information
Verified date March 2023
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to assess the benefit of locally delivered melatonin gel as adjunctive to scaling and root planning (SRP) in the treatment of chronic periodontitis.

Description:

Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month. The periodontal parameters were recorded at baseline, 1week, 1and 3 months.Gingival crevicular fluid (GCF) samples were collected and a quantitative measurement of receptor activator nuclear K ligand (RANKL) was carried out by using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline, 1week, 1 and 3 months.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 39 Years
Eligibility Inclusion Criteria: clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene Exclusion Criteria: Diabetic mellitus immunsuppressive medication

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Melatonin2%gel
Intra-pocket application of 2% Melatonin gel
• PLACEBO
placebo intra-pocket application

Locations
Country Name City State
Egypt Alazhar university ,faculty of Dental Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

kotb, shaymaa Hussein Rafat

Outcome
Type Measure Description Time frame Safety issue
Other pre-opertive measurements of clinical parameter in chronic periodontitis negative result in clinical parameter measurments by millimeter at beginning of trial
Primary Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis. positive change in clinical parameter by millimeter 2 weeks
Primary EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss" positive change in clinical parameter by millimeter 1: 3 months
Secondary EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF) microbiology analysis by Receptor activator nuclear K ligand(ELISA ) by picogram 3 months
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