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

ConditionPeriodontal Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Systemically healthy patients diagnosed with Stage II Grade B Periodontitis

Patients with good oral hygiene compliance

Disqualifiers

Smokers (due to the effect of smoking on melatonin levels and healing)

Pregnant or lactating females.

Patients who have received antibiotics, anti-inflammatory drugs, or antioxidant supplements within the last 6 months.

Patients taking systemic melatonin for sleep disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 2% Melatonin gel

    Other intervention

    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.

  • Placebo Gel

    Other intervention

    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.

Treatment groups

23 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in clinical attachment loss

Measurements will be recorded using a graduated William's periodontal probe

Time frame
Baseline and 8 weeks

Secondary outcomes

1

Change in Probing Pocket Depth

Measurements will be recorded using a graduated William's periodontal probe

Time frame
Baseline and 8 weeks
2

Change in Bleeding on probing

Measurements will be recorded using a graduated William's periodontal probe

Time frame
Baseline and 8 weeks
3

Change in Melatonin levels in Gingival Crevicular Fluid

The collected GCF samples will be analyzed using a commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kit specific for human melatonin

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: