drugset / Trial / NCT03368430

Melatonin as an Adjunctive Therapy for Chronic Periodontitis.

NCT03368430

Phase 4 Completed 74 enrolled Mansoura University
RandomizedParallel-groupDouble-blindTreatment

Summary

Background: Melatonin is an endogenous indoleamine synthesized mainly by pineal gland and showed anti-inflammatory and antioxidant properties. Moreover, melatonin promotes osteoblastic differentiation and suppresses osteoclastic formation. This randomized clinical trial (RCT) was aimed to assess the additive effect of melatonin supplementation in generalized chronic periodontitis (gCP) patients with insomnia who received scaling and root planing (SRP). Methods: Seventy four gCP patients with primary insomnia participated in this 6-month RCT and randomly distributed between two groups. Melatonin group (MTN+SRP group, n=38) included patients who were subjected to SRP with a 2- month regimen of 10 mg oral melatonin supplementation capsule once daily at bed-time. In the control group (Placebo+SRP group, n=36), SRP was performed for participants provided with matching placebo capsules. The primary treatment outcome included the clinical attachment gain (CAG) after 3 and 6 months of therapy, whereas, the changes in pocket depth ,bleeding on probing (BOP%) and salivary tumor-necrosis factor-α (TNF-α) levels represented the secondary outcomes.

Timeline

Start
2016-07-04
Primary completion
2017-06-08
Completion
2017-09-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 10 mg Oral

Indications