The Effects of Melatonin Supplementation on Periodontal and Metabolic Parameters in Type 2 Diabetes Mellitus Patients with Chronic Periodontitis Under Non-surgical Periodontal Therapy. A Placebo-Controlled, Double-Blind, Randomized Clinical Trial

Background: The Objective of present study was to evaluate the effects of melatonin supplementation on periodontal and metabolic parameters in type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP) under non-surgical periodontal therapy (NSPT). Material and methods: In this double-blind clinical trial study, 50 T2DM patients with CP were randomly allocated to control and intervention groups. The intervention and control groups received either 2 tablets melatonin or placebo (250 mg) once a day for 8 weeks. At baseline, the NSPT including scaling and root surface debridement was performed for two groups of intervention and control. The second stage of NSPT was performed after one month of intervention. Periodontal parameters including plaque, pocket depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP), glycosylated hemoglobin levels (HbA1c), fasting blood glucose (FBG), triglyceride )TG(, total cholesterol (CHOL), high-density (HDL) and low-density lipoprotein (LDL) cholesterol, VLDL (very low-density lipoprotein), diastolic blood pressure (DBP), systolic blood pressure (SBP), waist and hip circumference (WC, HC), weight, body mass index (BMI) and interleukin-6 (IL-6) were measured in patients before and after intervention. In the present study, the primary outcome was measurement of IL-6. All data were presented as mean ± SD. Normal distribution of data was checked using Kolmorogov-Smirnoff test. Independent sample t-test was used to compare the results between two groups. Paired sample t-test was also used to compare within-group differences (before and after intervention). The P < 0.05 were considered as significant. Results: In the intervention group, a significant decrease was observed in the mean levels of HbA1c, weight, BMI, WC, HC, IL-6, SBP, DBP, CAL and PD (p < 0.05). The mean serum levels of HDL was significantly increased in the intervention group after the intervention (p < 0.05). There were significant differences in the mean changes of HbA1c, HDL, weight, BMI, WC, HC, SBP, DBP, IL-6, CAL and PD between 2 intervention and control groups post- intervention. Conclusion: The combination of NSPT and melatonin may be effective in controlling the glycemic, lipid, BP, inflammation, weight and periodontal status in T2DM with CP.

کلیدواژه ها:

Melatonin ، Glycemic control ، Type 2 diabetes mellitus ، Periodontal disease ، Lipid profile The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences approved this research project (Ref No. IR.AJUMS.REC.1395.685) and this work was registered in the Iranian Registry of Clinical Trials website (IRCT2017011631993N1).