Melatonin as an Adjunctive Therapy for Chronic Periodontitis.

• Status: Completed
• Trial end date: 2017-09-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Patients were considered eligible for participation if they had Athens Insomnia Scale (AIS) score ≥ 6.

• Each selected patient should have at least 20 teeth.

• The enrolled patients were diagnosed to have moderate to severe gCP based on Armitage's classification.

Exclusion Criteria:

• diabetes mellitus.

• smokers.

• individuals having night work shifts.

• cancer patients.

• patients with autoimmune diseases or osteoporosis.

• users of antibiotics or non-steroidal anti-inflammatory drugs within the last 3 months.

• patients who were subjected to any periodontal therapy during the last year.