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

Al-Azhar University

Status and phase: Invitation-only; Phase 4

Conditions: Periodontitis Stage II

Treatments: Drug: Melatonin-Loaded Injectable Platelet-Rich Fibrin; Biological: injectible platelet rich fibrin (i-PRF )

Study type: Interventional

Funder types: Other

Identifiers

NCT07316582

P-ME-25-16

Details and patient eligibility

About

melatonin loaded in injectible platelet rich fibrin in treatment of periodontitis

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Scaling and Root Planning only

No Intervention group

Description:

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

Injectable Platelet-Rich Fibrin (i-PRF)

Placebo Comparator group

Description:

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

Treatment:

Biological: injectible platelet rich fibrin (i-PRF )

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

Experimental group

Description:

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

Treatment:

Drug: Melatonin-Loaded Injectable Platelet-Rich Fibrin