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

NCT05870358 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-05-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Melatonin 3 MG

In this clinical trial, all patients that have both diabetes mellitus and periodontitis were performed full mouth scaling and root planning in order to start their periodontal treatments. Different from the control group, in fmSRP-mel group's patients systemic melatonin tablets (6 mg daily, for 30 days) were given immediately after the fmSRP procedure in order to support the scaling and root planning.

Sponsors & Collaborators

  • Yağmur Saraç Gül

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
31 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870358 on ClinicalTrials.gov