Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Melatonin2%gel
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene Exclusion Criteria: Diabetic mellitus immunsuppressive medication

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic periodontitis, Melatonin, RANKL (Receptor activator nuclear K ligand), ELISA (Enzyme-Linked Immunosorbent Assay), Gingival crevicular fluid