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NOT YET RECRUITING
NCT07813936
NA

Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis

Sponsor: Alexandria University

View on ClinicalTrials.gov

Summary

Background: Periodontitis is a chronic inflammatory disease characterized by the destruction of tooth-supporting tissues, driven by an imbalance between bacterial pathogens and the host immune response. This inflammatory process leads to the excessive production of reactive oxygen species (ROS), causing oxidative stress and tissue damage. Melatonin is a potent antioxidant and immunomodulator that scavenges free radicals and reduces inflammation. Previous research indicates that salivary and gingival crevicular fluid (GCF) melatonin levels are significantly reduced in patients with periodontitis compared to healthy individuals, suggesting its potential utility as a biomarker for periodontal health. Aim: The aim of this study is to evaluate the efficacy of 2% melatonin gel administered locally into periodontal pockets as an adjunct to subgingival instrumentation in patients with Stage II Grade B periodontitis.

Official title: The Effect of Locally Delivered Melatonin Gel as an Adjunctive to Non-surgical Periodontal Therapy in the Management of Stage II Grade B Periodontitis: a Split-mouth Randomised Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2026-09-10

Completion Date

2027-09-30

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

OTHER

2% Melatonin gel

All qualifying periodontal pockets on the randomly assigned test side will receive Non-Surgical Periodontal Therapy (NSPT) followed immediately by the subgingival application of 2% Melatonin gel.

OTHER

Placebo Gel

All qualifying periodontal pockets on the contralateral side will receive Non-Surgical Periodontal Therapy (NSPT) followed immediately by the subgingival application of the Placebo gel.

Locations (1)

Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt