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Clinical trial

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

ID
Name
AADJ-2111-1091
Description
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.
Trial arms
Trial start
2020-04-01
Estimated PCD
2020-12-01
Trial end
2021-03-01
Status
Completed
Phase
Early phase I
Treatment
Melatonin2%gel
Intra-pocket application of 2% Melatonin gel
Arms:
Gp I(Melatonin gp)
Other names:
intra- pocket Melatonin gel
PLACEBO
placebo intra-pocket application
Arms:
Gp II(placebo gp)
Size
40
Primary endpoint
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
2 weeks
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"
1: 3 months
Eligibility criteria
Inclusion Criteria: clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene Exclusion Criteria: Diabetic mellitus immunsuppressive medication
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-03-10

1 organization

2 products

1 indication

Organization
Al-Azhar University
Product
Melatonin2%gel
Indication
Chronic Periodontitis
Product
PLACEBO