Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus

NCT07846891 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: FDASU -Rec 102411
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

The Injectable PRF (i-PRF) is a variant of PRF, which is a liquid blood derivative rich in leukocytes and acts as a growth factor release, with its potential anti-inflammatory role, it may alleviate the symptoms of OLP. Low Level Laser Therapy (LLLT) emits short wavelength red or infrared light between (500-1100 nm) with a low water absorption. This light can reach a depth of 3 mm to 15 mm in both soft and hard tissues, the biostimulatory effect of laser irradiation results in physiological, metabolic, and functional changes in living microorganisms. The investigators compared the clinical effectiveness of LLLT combined with (i-PRF) to the application of (i-PRF) alone and to that of topical corticosteroid regimen in symptomatic OLP and investigated therapeutic mechanism by examining treatment effect on expression of Tumor necrosis factor alpha (TNF-alpha) and Vascular endothelial growth factor (VEGF) in salivary samples from OLP patients.

Conditions

Oral Lichen Planus

Keywords

Oral Lichen Planus; Low level laser therapy with Injectable Platelet Rich Fibrin; TNF-alpha

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation

  Healing potential regarding the size of OLP lesions: 0: represented no lesion/normal mucosa 1. mild white striae/no erythematous area 2. white striae with atrophic area less than 1 cm2 3. white striae with atrophic area more than 1 cm2 4. white striae with erosive area less than 1 cm2 5. white striae with erosive area more than 1 cm2

  At baseline and once weekly for 1 month (treatment period).

Secondary Outcomes (2)

• Severity of symptoms

  At baseline (before 1 injection), after last injection and every 2 weeks for 3 months

• Tumor necrosis factor alpha (TNF-a) & Vascular endothelial growth factor (VEGF)

  at baseline, and 1 week after end of treatment period

Study Arms (3)

Injectable Platelet Rich Fibrin (i-PRF)

EXPERIMENTAL

1 ml of (i-PRF) obtained after centrifuging 10 ml of peripheral venous blood from OLP patient, will be injected once weekly for 1 month.

Other: Injectable Platelet Rich Fibrin

Low Level Laser therapy (LLLT) / (i -PRF)

EXPERIMENTAL

1 ml of (i- PRF) once weekly for 1 month followed by (LLLT) at 940 nm for 180 seconds twice weekly, 8 sessions for 1 month.

Other: Injectable Platelet Rich Fibrin; Radiation: Low Level Laser Therapy

Topical corticosteroid

ACTIVE COMPARATOR

Injectional triamcinolone acetonide (TA) (40 mg/ml; Epico) once weekly for 1 month

Drug: Triamcinolone acetonide (injection)

Interventions

Injectable Platelet Rich Fibrin OTHER

Injectable Platelet Rich Fibrin (i- PRF) is a variant of PRF, a liquid blood derivative produced by using blood without anticoagulant or artificial biochemical modifications centrifuged at 700 rpm (60 g) for 3 mins in plastic tubes without any coatings.

Injectable Platelet Rich Fibrin (i-PRF); Low Level Laser therapy (LLLT) / (i -PRF)

Low Level Laser Therapy RADIATION

Low Level Laser Therapy (LLLT) is a non invasive treatment, that emits short wavelength red or infrared light between (500-1100 nm) with a low water absorption. The bio stimulatory effect of laser irradiation results in physiological, metabolic, and functional changes in living microorganisms.

Low Level Laser therapy (LLLT) / (i -PRF)

Triamcinolone acetonide (injection) DRUG

Topical corticosteroid

Topical corticosteroid

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically and histologically proven painful Bullous/ erosive or atrophic forms of OLP.

You may not qualify if:

• History of drug induced lichenoid lesions. 2. Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
• \. Smoking. 4. Pregnancy or breast-feeding. 5. Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
• \. Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
• \. Refusing to participate in the study. 8. Vulnerable groups (handicapped).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Faculty of Dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Low-Level Light Therapy; Triamcinolone Acetonide; Injections

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Drug Administration Routes; Drug Therapy

Study Officials

• Nevine Hassan Kheir EL Din, Professor

  Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

• Olfat Gamil Shaker, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD degree at Oral Medicine and Periodontology

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)