Melatonin Supports Non Surgical Periodontal Treatment in Patients With Type 2 Diabetes and Periodontitis

• Status: Completed
• Trial end date: 2022-06-18
• Target enrollment: 0
• Participant gender: All

Summary

Background and aim: Hyperinflammatory host response associated with diabetes mellitus significantly provokes periodontal tissue destruction. In this context, supporting the standard treatment of periodontitis in diabetics with host modulation agents is a current field of study.

This clinical study aims to investigate the clinical efficacy of melatonin supplementation in non-surgical periodontal treatment in patients with Type 2 DM and periodontitis and its biological basis (clinical effectiveness) based on some basic markers.

Material and method: In this randomized controlled and double-blind study, 27 of 55 patients with diabetic periodontitis underwent full mouth scaling and root planning (fmSRP) alone and 28 of them were administered melatonin (6 mg daily, for 30 days) in addition to fmSRP. The possible therapeutic contribution of melatonin was evaluated clinically and biochemically [gingival crevicular fluid (GCF) RANKL, OPG and MMP-8 and serum IL-1β levels] at 3 and 6 months.

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

Details

• Lead Sponsor: Yağmur Saraç Gül
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• According to the WHO, in individuals in the young age category (18-65 years)

• Periodontitis diagnosed patients, "stage 3/4 periodontitis" was determined according to the current periodontal disease and condition classification as the diagnostic criterion for periodontitis

• Diabetic patients, our diagnostic criteria for Type 2 DM was fasting plasma glucose level greater than 126 mg/dl and glycosylated hemoglobin level (HbA1c) greater than 6.5%.

Exclusion Criteria:

• Smoke, use antibiotics, anti-inflammatory and antioxidant drugs in the last 6 months

• Work night shifts

• Pregnancy and lactation

• Cancer and autoimmune diseases

• Kidney disease

• Periodontal treatment in the last 6 months

• Obese patients (In Europe, obesity is defined as a body-mass index of more than 30 kg/m2 and a waist circumference of more than 88 cm in women and 102 cm in men)