drugset / Trial / NCT05870358

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

NCT05870358

Phase 4 Completed 55 enrolled Yağmur Saraç Gül
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-02-18
Primary completion
2022-01-18
Completion
2022-06-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 6 mg Oral