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

NCT07605767 | Completed Phase 4

• 1 other identifier: ASRB/No./09930/MS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in Probing Pocket Depth (PPD)

  Measured using a UNC-15 periodontal probe in millimeters from baseline to 3 months following non-surgical periodontal therapy.

  3 Months

• Change in Clinical Attachment Level (CAL)

  Measured using a UNC-15 periodontal probe in millimeters from baseline to 3 months following non-surgical periodontal therapy.

  3 Months

Secondary Outcomes (2)

• Change in Gingival Index (GI)

  3 Months

• Change in Plaque Index (PI)

  3 Months

Study Arms (2)

Test Group

EXPERIMENTAL

Participants in the experimental group received non-surgical periodontal therapy (scaling and root planing) followed by intrapocket application of 5% topical melatonin gel. The gel was applied weekly during the first month after therapy. Clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL), were evaluated at baseline and after three months to assess treatment outcomes.

Drug: Topical 5% Melatonin Gel

Control Group

PLACEBO COMPARATOR

Participants in the control group received non-surgical periodontal therapy (scaling and root planing) followed by intrapocket application of placebo gel identical in appearance to the melatonin gel but without the active ingredient. The placebo gel was applied weekly during the first month after therapy. Clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL), were evaluated at baseline and after three months to assess treatment outcomes.

Other: Placebo

Interventions

Topical 5% Melatonin Gel DRUG

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.

Test Group

Placebo OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-45 years
• Patients diagnosed with periodontitis with clinical attachment loss (CAL) between 3-4 mm
• Systemically healthy individuals
• Patients with controlled systemic diseases (ASA I \& II)
• Patients willing to participate and provide informed consent

You may not qualify if:

• Smokers or tobacco users
• Pregnant or lactating females
• Patients with uncontrolled diabetes mellitus (HbA1c \>6.5%)
• Patients who received periodontal therapy within the last 6 months
• Patients who used antibiotics, anti-inflammatory drugs, sleeping pills, or antioxidant supplements within the last 6 months
• Individuals working night shifts -Patients with mental illness or neuromuscular disorders-
• Patients unwilling to participate or unable to comply with follow-up visits

Sponsors & Collaborators

• Liaquat College of Medicine and Dentistry: lead

Study Sites (1)

Liaquat College of Medicine and Dentistry

Karachi, Sindh, 7290, Pakistan

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 26, 2026
• Study Start: November 3, 2025
• Primary Completion: January 5, 2026
• Study Completion: April 10, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)