Oral Lichen PlanusPhase 4NCT07846891
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
A Phase 4 study testing Injectable Platelet Rich Fibrin, Low Level Laser Therapy and Triamcinolone acetonide (injection) in people with Oral Lichen Planus, run by Ain Shams University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Injectable Platelet Rich Fibrin, Low Level Laser Therapy and Triamcinolone acetonide (injection)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Mar 2026to 20 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically and histologically proven painful Bullous/ erosive or atrophic forms of OLP.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry, Ain Shams University
Cairo, Cairo Governorate
Faculty of Dentistry, Ain Shams University
Cairo
About this study
Official title: 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
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.
Read the 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
- mild white striae/no erythematous area
- white striae with atrophic area less than 1 cm2
- white striae with atrophic area more than 1 cm2
- white striae with erosive area less than 1 cm2
- 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.
- Conditions
- Oral Lichen Planus
- Being tested
- Injectable Platelet Rich Fibrin, Low Level Laser Therapy, Triamcinolone acetonide (injection)
- Keywords
- Oral Lichen Planus, Low level laser therapy with Injectable Platelet Rich Fibrin, TNF-alpha
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet Rich FibrinOther
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.
Low Level Laser TherapyRadiation
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.
Triamcinolone acetonide (injection)Drug
Topical corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: Triamcinolone acetonide (injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Healing potential regarding the size of OLP lesions:
0: represented no lesion/normal mucosa
- mild white striae/no erythematous area
- white striae with atrophic area less than 1 cm2
- white striae with atrophic area more than 1 cm2
- white striae with erosive area less than 1 cm2
- white striae with erosive area more than 1 cm2
Measured: At baseline and once weekly for 1 month (treatment period).
Secondary outcomes (2)
Severity of symptoms
Visual Analogue Score for pain (VAS):
0: no complaint, while 10 reflected the most severe complaint.
Measured: 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)
Biochemical evaluation of salivary levels of cytokines using the enzyme linked immunosorbent assay technique (ELISA)
Measured: at baseline, and 1 week after end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Mar 2026
- Primary completion20 Apr 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura ali kafa, Ain Shams University
- Investigators
- Nevine Hassan Kheir EL Din, Professor, Study director, Faculty of Dentistry, Ain Shams UniversityOlfat Gamil Shaker, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846891
- Sponsor's protocol ID
- FDASU -Rec 102411
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07846891
- Acronym / sponsor ID
- FDASU -Rec 102411
- Conditions
- Oral Lichen Planus
- Keywords
- Oral Lichen Planus, Low level laser therapy with Injectable Platelet Rich Fibrin, TNF-alpha
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- mild white striae/no erythematous area
- white striae with atrophic area less than 1 cm2
- white striae with atrophic area more than 1 cm2
- white striae with erosive area less than 1 cm2
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injectable Platelet Rich Fibrin (i-PRF) | Experimental | Other: Injectable Platelet Rich Fibrin1 ml of (i-PRF) obtained after centrifuging 10 ml of peripheral venous blood from OLP patient, will be injected once weekly for 1 month. |
| Low Level Laser therapy (LLLT) / (i -PRF) | Experimental | Other: Injectable Platelet Rich Fibrin, Radiation: Low Level Laser Therapy1 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. |
| Topical corticosteroid | Active comparator | Drug: Triamcinolone acetonide (injection)Injectional triamcinolone acetonide (TA) (40 mg/ml; Epico) once weekly for 1 month |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically and histologically proven painful Bullous/ erosive or atrophic forms of OLP.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable Platelet Rich FibrinInjectable 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. | Other | Injectable Platelet Rich Fibrin (i-PRF), Low Level Laser therapy (LLLT) / (i -PRF) |
| Low Level Laser TherapyLow 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. | Radiation | Low Level Laser therapy (LLLT) / (i -PRF) |
| Triamcinolone acetonide (injection)Topical corticosteroid | Drug | Topical corticosteroid |
Primary outcome
Clinical evaluation
Time frame: At 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
2 secondary outcomes
Severity of symptoms
Time frame: 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)
Time frame: at baseline, and 1 week after end of treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevine Hassan Kheir EL Din, Professor study director
Faculty of Dentistry, Ain Shams University
Olfat Gamil Shaker, Professor study chair
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Injectable Platelet Rich Fibrin, Low Level Laser Therapy and Triamcinolone acetonide (injection) in people with Oral Lichen Planus, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation (time frame: At baseline and once weekly for 1 month (treatment period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.