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

Low Level Laser Therapy Combined With Injectable Platelet Rich Fibrin Versus Injectable Platelet Rich Fibrin in Management of Symptomatic Oral Lichen Planus : A Randomized Controlled Clinical Study With Biochemical Analysis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07846891
Enrollment
39
Registered
2026-09-29
Start date
2026-03-15
Completion date
2027-05-20
Last updated
2026-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

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

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.

Detailed description

Thirty nine patients diagnosed histopathologically with OLP will be included in this study where a topical anesthetic gel containing 20% benzocaine will be applied to the OLP region, then 10 ml of peripheral venous blood will be collected from each patient and placed in dry sterile 13 ml plastic i-PRF tubes, without using an anticoagulant and centrifuged immediately (Process for PRF, Nice, France) at room temperature using a low relative centrifugal force (700 rpm for 3 min, 60 g force). The yellow- orange top portion of the tube will be then collected in an insulin syringe connected to a 27G needle to obtain approximately 1ml of i-PRF, which then will be injected once weekly for one month at four different endpoints at the periphery of the lesion into the subepithelial tissue underlying the lesion and adjacent to the normal mucosa (group 1), in addition to the (i-PRF) treatment, LLLT will also be delivered by the (Biolase diode laser 940 nm) with the following parameters: wavelength= 940 nm, duration = 180s, with a power of 100 mw/cm2, in a continuous non- contact mode, 0.5 cm away from tissues, with a power of 1.5 J/cm2. LLLT will be applied twice per week for one month in eight sessions (group 2). In control group, Triamcinolone acetonide injection (40 mg/ml) will be injected once weekly for one month with an insulin syringe 27-gauge needle at the same four endpoints. Each injection will be 0.5 mL per session (group 3). A clinical assessment will be carried out at baseline and once weekly up to one month within the treatment period, and once every 15 days up to 3 months (during the follow up period), where the marker lesion in each patient will be assessed for areas of erosion and ulceration by visual examination and the scoring will be recorded as follows: 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. Salivary samples of whole unstimulated saliva (WUS) will be collected from all patients in three groups at baseline and 1 week after end of treatment period between 9:00 and 11:00 a.m, where the patients will be refrained from eating, drinking, using chewing gum, mints, etc. for at least 1½ h prior to the evaluation. Samples will be obtained by requesting patients to swallow first, tilt their head forward, and expectorate into a 50 ml polypropylene sterile tubes for 5 min without swallowing. After collection, all samples will be kept on ice until assayed, where TNF-alpha and VEGF concentrations will be determined using commercially available quantitative sandwich ELISA kits.

Interventions

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.

RADIATIONLow Level Laser Therapy

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.

DRUGTriamcinolone acetonide (injection)

Topical corticosteroid

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1- 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. 3\. Smoking. 4. Pregnancy or breast-feeding. 5. Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus. 6\. Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites. 7\. Refusing to participate in the study. 8. Vulnerable groups (handicapped).

Design outcomes

Primary

MeasureTime frameDescription
Clinical evaluationAt baseline and once weekly for 1 month (treatment period).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

Secondary

MeasureTime frameDescription
Severity of symptomsAt baseline (before 1 injection), after last injection and every 2 weeks for 3 monthsVisual Analogue Score for pain (VAS): 0: no complaint, while 10 reflected the most severe complaint.
Tumor necrosis factor alpha (TNF-a) & Vascular endothelial growth factor (VEGF)at baseline, and 1 week after end of treatment periodBiochemical evaluation of salivary levels of cytokines using the enzyme linked immunosorbent assay technique (ELISA)

Countries

Egypt

Contacts

STUDY_DIRECTORNevine Hassan Kheir EL Din, Professor

Faculty of Dentistry, Ain Shams University

STUDY_CHAIROlfat Gamil Shaker, Professor

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 30, 2026