At a glance
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Is Dietary Melatonin Supplementation a Viable Adjunctive Therapy for Chronic Periodontitis? A Preliminary Randomized Clinical Trial.
In Brief
A Phase 4 clinical trial evaluating Melatonin and Placebo for Periodontal Diseases. Completed, enrolled 74 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
After performing scaling and root planing (SRP) in the test group, melatonin 10 mg oral capsule was taken once daily at night prior to bedtime for only 2 months during the 6-month study period
After finishing scaling and root planing (SRP) in the control group, placebo capsule was taken once daily at bedtime for two months.