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

NCT07813936 | Not Yet Recruiting

• 1 other identifier: 1340-0512026
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Change in clinical attachment loss

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

  Baseline and 8 weeks

Secondary Outcomes (3)

• Change in Probing Pocket Depth

  Baseline and 8 weeks

• Change in Bleeding on probing

  Baseline and 8 weeks

• Change in Melatonin levels in Gingival Crevicular Fluid

  Baseline and 8 weeks

Study Arms (2)

Test Group

EXPERIMENTAL

Other: 2% Melatonin gel

Control

PLACEBO COMPARATOR

Other: Placebo Gel

Interventions

2% Melatonin gel OTHER

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.

Test Group

Placebo Gel OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients diagnosed with Stage II Grade B Periodontitis
• Patients with good oral hygiene compliance

You may not qualify if:

• 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.
• Patients who have undergone periodontal therapy in the last 6 months.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Nourhan Kamel, BDS

CONTACT

01147473085; nourhan.ezzeldin.dent@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised split-mouth clinical trial in which each participant receives both interventions.

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 10, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

EG (1)