Melatonin as an Adjunctive Therapy for Chronic Periodontitis.
Status:
Completed
Trial end date:
2017-09-07
Target enrollment:
Participant gender:
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.