Effects of melatonin supplementation in patients with type 2 diabetes mellitus and chronic periodontitis under nonsurgical periodontal therapy: A double-blind randomized controlled trial

Background: The aim of the present study was to investigate the effects of melatonin supplementation along with nonsurgical periodontal therapy ( NSPT) in patients with type 2 diabetes mellitus (T2DM) and chronic periodontitis (CP). Materials and Methods: The present study was a double-blind clinical trial. Fifty diabetic patients with periodontitis were randomly allocated to control (n = 25) and intervention groups (n = 25). Two tablets of 250 mg melatonin (6 mg net melatonin) or placebo were received by the intervention or control groups once a day for 8 weeks. Fasting blood glucose (FBG), glycosylated hemoglobin levels (HbA1c), lipid profile, systolic and diastolic blood pressure (SBP and DBP), anthropometric indices including weight, waist and hip circumference (WC and HC), and body mass index (BMI) were measured in patients at the beginning and end of the intervention. Results: Forty-four patients (22 patients in each group) completed the study. In the intervention group, a significant reduction was observed in HbA1c (P = 0.004), weight, BMI, WC, HC (all P < 0.001), DBP (P= 0.017), and SBP (P = 0.006). The high-density lipoprotein-cholesterol was significantly increased in the intervention group after the intervention (P = 0.007). Moreover, after the adjustment of confounding factors, the mean changes of HbA1c (mean difference: -1.30, confidence interval [CI]: -2.41--0.19, P = 0.02), weight (mean difference: -3.90, CI: -5.30-2.50, P < 0.001), WC (mean difference: -1.37, CI: -2.19--0.55, P = 0.002), BMI (mean difference: -1.41, CI: -1.92--0.89, P < 0.001), HC (mean difference: -3.55, CI: -4.74--2.35, P < 0.001), and SBP (mean difference: -1.24, CI: -2.41--0.06, P = 0.03) improved significantly in the intervention group by comparison with the control group. No side effects were reported during the study. Conclusion: The adjunct therapy of NSPT and melatonin may be useful in controlling the glycemic index, lipid profile, BP, and weight in T2DM with CP.