Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

Phase 4

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: PLACEBO; Drug: Melatonin2%gel

• Registration Number: NCT05759416
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-03-01
• Study First Submitted: 2023-01-13
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

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

Inclusion Criteria

clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene

Exclusion Criteria

Diabetic mellitus immunsuppressive medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gp II(placebo gp)	PLACEBO	Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month
Gp I(Melatonin gp)	Melatonin2%gel	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.	2 weeks	positive change in clinical parameter by millimeter
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"	1: 3 months	positive change in clinical parameter by millimeter

Secondary Outcome Measures

Name	Time	Method
EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)	3 months	microbiology analysis by Receptor activator nuclear K ligand(ELISA ) by picogram

Trial Locations

Locations (1)

Alazhar university ,faculty of Dental Medicine; 🇪🇬 Assiut, Egypt