Back to resultsEvaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin2%gel
PLACEBO
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Periodontitis focused on measuring Chronic periodontitis, Melatonin, RANKL (Receptor activator nuclear K ligand), ELISA (Enzyme-Linked Immunosorbent Assay), Gingival crevicular fluid
Eligibility Criteria
Inclusion Criteria: clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene Exclusion Criteria: Diabetic mellitus immunsuppressive medication
Sites / Locations
- Alazhar university ,faculty of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Gp I(Melatonin gp)
Gp II(placebo gp)
Arm Description
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
Outcomes
Primary Outcome Measures
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
positive change in clinical parameter by millimeter
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"
positive change in clinical parameter by millimeter
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05759416
Brief Title
Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis
Official Title
Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic periodontitis, Melatonin, RANKL (Receptor activator nuclear K ligand), ELISA (Enzyme-Linked Immunosorbent Assay), Gingival crevicular fluid
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gp I(Melatonin gp)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Gp II(placebo gp)
Arm Type
Placebo Comparator
Arm Description
Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month
Intervention Type
Drug
Intervention Name(s)
Melatonin2%gel
Other Intervention Name(s)
intra- pocket Melatonin gel
Intervention Description
Intra-pocket application of 2% Melatonin gel
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
placebo intra-pocket application
Primary Outcome Measure Information:
Title
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
Description
positive change in clinical parameter by millimeter
Time Frame
2 weeks
Title
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"
Description
positive change in clinical parameter by millimeter
Time Frame
1: 3 months
Secondary Outcome Measure Information:
Title
EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)
Description
microbiology analysis by Receptor activator nuclear K ligand(ELISA ) by picogram
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
pre-opertive measurements of clinical parameter in chronic periodontitis
Description
negative result in clinical parameter measurments by millimeter
Time Frame
at beginning of trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene
Exclusion Criteria:
Diabetic mellitus immunsuppressive medication
Facility Information:
Facility Name
Alazhar university ,faculty of Dental Medicine
City
Assiut
ZIP/Postal Code
0000
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://aadj.journals.ekb.eg/article_234723.html
Citations:
Citation
kotb, shaymaa Hussein Rafat
Results Reference
result
Links:
URL
https://orcid.org/my-orcid?orcid=0000-0002-8404-438X
Description
shaymaa+kotb@orcid
Learn more about this trial
Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis
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