Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management Periodontitis

NCT07316582 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: P-ME-25-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

melatonin loaded in injectible platelet rich fibrin in treatment of periodontitis

Conditions

Periodontitis Stage II

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL)

  6 months

Study Arms (3)

Scaling and Root Planning only

NO INTERVENTION

Mechanical removal of supra- and subgingival plaque and calculus using ultrasonic and hand instruments.

Injectable Platelet-Rich Fibrin (i-PRF)

PLACEBO COMPARATOR

local application of injectable platelet-rich fibrin (i-PRF) into periodontal pockets.

Biological: injectible platelet rich fibrin (i-PRF )

scaling and Root Planing plus Melatonin-Loaded Injectable Platelet-Rich Fibrin

EXPERIMENTAL

patients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection

Drug: Melatonin-Loaded Injectable Platelet-Rich Fibrin

Interventions

Melatonin-Loaded Injectable Platelet-Rich Fibrin DRUG

patients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection

scaling and Root Planing plus Melatonin-Loaded Injectable Platelet-Rich Fibrin

injectible platelet rich fibrin (i-PRF ) BIOLOGICAL

patients will be included in this group receiving (SRP) with local application of i-PRF

Injectable Platelet-Rich Fibrin (i-PRF)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Diagnosed with stage II periodontitis based on AAP/EFP 2018 classification
• Minimum of two non-adjacent periodontal pockets \<5 mm in different quadrants
• Systemically healthy individuals willing to participate and comply with follow-up visits
• Radiographic bone loss (ranged from is 10-20% mostly horizontal

You may not qualify if:

• History of systemic diseases affecting periodontium (e.g., diabetes, osteoporosis)
• Use of antibiotics, anti-inflammatories, or antioxidant supplements in the past 3 months
• Smoking or tobacco use
• Pregnancy or lactation
• Allergy to melatonin or related compounds

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine for girls Al-Azhar University

New Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

proliferation regulatory factors, human urine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Oral Medicine, Periodontology and Diagnosis, Faculty of Dental Medicine for girls, Al -Azhar University, Cairo, Egypt

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

EG (1)