Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis
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
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:
|
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
- 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
- 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
- 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
- pre-opertive measurements of clinical parameter in chronic periodontitis [at beginning of trial]
negative result in clinical parameter measurments by millimeter
Eligibility Criteria
Criteria
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.- AADJ-2111-1091
- Aadj@azhar.edu.eg