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Adjunctive Topical Melatonin Gel in Non-Surgical Periodontal Therapy for Periodontitis

NCT07605767 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-26

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the clinical effectiveness of adjunctive topical melatonin gel when used with non-surgical periodontal therapy (NSPT) in adult patients with periodontitis. This study includes systemically healthy or medically controlled patients aged 18-45 years who are diagnosed with periodontitis and attend the Department of Periodontology at Liaquat College of Medicine \& Dentistry, Karachi.

The main questions it aims to answer are:

* Does adjunctive topical 5% melatonin gel improve clinical attachment level (CAL) compared to placebo after NSPT?
* Does adjunctive topical 5% melatonin gel improve plaque index (PI), gingival index (GI), and periodontal pocket depth (PPD) compared to placebo after NSPT? Researchers will compare patients receiving NSPT with topical melatonin gel to patients receiving NSPT with placebo gel to determine whether melatonin provides additional clinical benefits in periodontal therapy.

Participants will:

* Undergo baseline periodontal examination, including assessment of plaque index, gingival index, periodontal pocket depth, and clinical attachment level.
* Receive non-surgical periodontal therapy (scaling and root planing).
* Be randomly assigned to receive either 5% topical melatonin gel or placebo gel applied intra-pocket.
* Attend follow-up visits for gel application and monitoring.
* Undergo reassessment of clinical periodontal parameters after three months.
* Be monitored for any adverse effects during the study period. This study is a randomized, double-blind, placebo-controlled clinical trial evaluating the role of topical melatonin gel as an adjunct to conventional non-surgical periodontal therapy in improving periodontal clinical outcomes.

Conditions

  • Periodontal Disease
  • Melatonin

Interventions

DRUG

Topical 5% Melatonin Gel

A locally delivered 5% topical melatonin gel applied intra-pocket as an adjunct to non-surgical periodontal therapy (scaling and root planing). The gel was prepared using a standardized gel base and administered weekly during the first month of treatment. Melatonin gel was used to evaluate its potential anti-inflammatory, antioxidant, and periodontal healing effects in patients with periodontitis.

OTHER

Placebo

A locally delivered placebo gel applied intrapocketly as an adjunct to non-surgical periodontal therapy (scaling and root planing). The placebo gel contained the same gel base and appearance as the experimental melatonin gel but without the active melatonin ingredient. It was administered weekly during the first month of treatment to serve as a control for comparison of clinical periodontal outcomes.

Sponsors & Collaborators

  • Liaquat College of Medicine and Dentistry

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2026-01-05
Completion
2026-04-10

Countries

  • Pakistan

Study Locations

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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 NCT07605767 on ClinicalTrials.gov