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

NCT ID: NCT07316582

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-07-01

Brief Summary

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melatonin loaded in injectible platelet rich fibrin in treatment of periodontitis

Detailed Description

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Conditions

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Periodontitis Stage II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Scaling and Root Planning only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Injectable Platelet-Rich Fibrin (i-PRF)

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

Group Type PLACEBO_COMPARATOR

injectible platelet rich fibrin (i-PRF )

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

Melatonin-Loaded Injectable Platelet-Rich Fibrin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

injectible platelet rich fibrin (i-PRF )

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Nora Abdelgawad Mohamed

Associate Professor of Oral Medicine, Periodontology and Diagnosis, Faculty of Dental Medicine for girls, Al -Azhar University, Cairo, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dental Medicine for girls Al-Azhar University

New Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P-ME-25-16

Identifier Type: -

Identifier Source: org_study_id

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