Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

NCT05759416 | Completed Phase 4 DMC

• 2 other identifiers: AADJ-2111-1091Aadj@azhar.edu.eg
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis; Melatonin; RANKL (Receptor activator nuclear K ligand); ELISA (Enzyme-Linked Immunosorbent Assay); Gingival crevicular fluid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)

  3 months

Other Outcomes (1)

• pre-opertive measurements of clinical parameter in chronic periodontitis

  at beginning of trial

Study Arms (2)

Gp I(Melatonin gp)

ACTIVE COMPARATOR

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

Gp II(placebo gp)

PLACEBO COMPARATOR

Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month

Drug: PLACEBO

Interventions

Melatonin2%gel DRUG

Intra-pocket application of 2% Melatonin gel

Also known as: intra- pocket Melatonin gel

Gp I(Melatonin gp)

PLACEBO DRUG

placebo intra-pocket application

Gp II(placebo gp)

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Diabetic mellitus immunsuppressive medication

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar university ,faculty of Dental Medicine

Asyut, 0000, Egypt

Location

Related Publications (1)

• kotb, shaymaa Hussein Rafat

  RESULT

Related Links

• shaymaa+kotb@orcid

MeSH Terms

Conditions

Chronic Periodontitis; Osteopetrosis, mild autosomal recessive form

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: March 8, 2023
• Study Start: April 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: any time .It is already published
• Access Criteria: DOI: 10.21608/aadj.2022.267325

Locations

EG (1)