Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Melatonin2%gel; Drug: PLACEBO

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 0000
    • Alazhar university ,faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Diabetic mellitus immunsuppressive medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gp I(Melatonin gp); 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.	Drug: Melatonin2%gel; Intra-pocket application of 2% Melatonin gel; Other Names: intra- pocket Melatonin gel
Placebo Comparator: Gp II(placebo gp); Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month	Drug: PLACEBO; placebo intra-pocket application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pre-opertive measurements of clinical parameter in chronic periodontitis	negative result in clinical parameter measurments by millimeter	at beginning of trial

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• kotb, shaymaa Hussein Rafat

Helpful Links

• shaymaa+kotb@orcid

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Melatonin; Chronic periodontitis; Gingival crevicular fluid; RANKL (Receptor activator nuclear K ligand); ELISA (Enzyme-Linked Immunosorbent Assay)
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: AADJ-2111-1091; Aadj@azhar.edu.eg (Registry Identifier: ISSN 2682-2822)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: yes ,no problem to share study result
• IPD Sharing Time Frame: any time .It is already published
• IPD Sharing Access Criteria: DOI: 10.21608/aadj.2022.267325
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No