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

December 19, 2025 updated by: Nora Abdelgawad Mohamed, Al-Azhar University

Clinical and Biochemical Evaluation of Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management of Stage II Grade A Periodontitis: A Randomized Controlled Clinical Trial

melatonin loaded in injectible platelet rich fibrin in treatment of periodontitis

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • New Cairo, Egypt
        • Faculty of Dental Medicine for girls Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Scaling and Root Planning only
Mechanical removal of supra- and subgingival plaque and calculus using ultrasonic and hand instruments.
Placebo Comparator: Injectable Platelet-Rich Fibrin (i-PRF)
local application of injectable platelet-rich fibrin (i-PRF) into periodontal pockets.
Biological: injectible platelet rich fibrin (i-PRF )
patients will be included in this group receiving (SRP) with local application of i-PRF
Experimental: scaling and Root Planing plus Melatonin-Loaded Injectable Platelet-Rich Fibrin
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
patients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical attachment level (CAL)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-ME-25-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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