Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT05759416
Collaborator
(none)
40
1
2
11
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model 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.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.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    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]

      microbiology analysis by Receptor activator nuclear K ligand(ELISA ) by picogram

    Other Outcome Measures

    1. pre-opertive measurements of clinical parameter in chronic periodontitis [at beginning of trial]

      negative result in clinical parameter measurments by millimeter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 39 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

    Exclusion Criteria:

    Diabetic mellitus immunsuppressive medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alazhar university ,faculty of Dental Medicine Assiut Egypt 0000

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Shaymaa Hussein Rafat Kotb, principal investigator, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT05759416
    Other Study ID Numbers:
    • AADJ-2111-1091
    • Aadj@azhar.edu.eg
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shaymaa Hussein Rafat Kotb, principal investigator, Al-Azhar University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2023