Oral Submucous FibrosisPRP OSFNCT07914504
Autologous PRP Versus Triamcinolone Acetate in Patients With Oral Submucous Fibrosis
A study testing Autologous Platelet-Rich Plasma and Triamcinolone Acetate in people with Oral Submucous Fibrosis, run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial summary
Oral submucous fibrosis (OSF) is a chronic condition that causes stiffness of the oral tissues, reduced cheek flexibility, and difficulty opening the mouth. This randomized controlled clinical trial will compare the effects of intralesional autologous platelet-rich plasma (PRP) and triamcinolone acetate in patients… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Oral Submucous Fibrosis
- What is being tested?
- Autologous Platelet-Rich Plasma and Triamcinolone Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Both male and female patients
- Patients clinically diagnosed with Oral Submucous Fibrosis (OSF) based on history of betel nut or areca nut chewing, palpable fibrous bands in buccal mucosa, restricted cheek flexibility, and reduced maximum interincisal distance
- Patients with no previous history of medical or surgical treatment for OSF
- Patients willing to participate and give informed written consent
Who cannot join
- History of allergy to local anesthetics, PRP components, or corticosteroids
- Patients who underwent previous surgical treatment for OSF
- Patients with leukoplakic or erythroplakic changes of oral mucosa
- Patients tested positive for Hepatitis B or Hepatitis C
- Pregnant women and lactating mothers
- Patients suffering from systemic diseases (e.g., Diabetes Mellitus with HbA1c > 6.5%, Hypertension > 150/100 mmHg, chronic renal disease, chronic liver disease, anemia, or malnutrition)
- Patients with other concurrent oral mucosal lesions or oral malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Jinnah Hospital, Lahore / Allama Iqbal Medical College
Lahore, Punjab Province, 54550
Esha Khalid, BDS, Resident of OMFS, +92-321-4963558, khalidesha959@gmail.com
Esha Khalid, BDS, Resident of OMFS
About this study
Official title: Comparison of Effects of Intralesional Injection of Autologous Platelet-Rich Plasma Vs Triamcinolone Acetate on Trismus/Maximum Interincisal Distance and Cheek Flexibility in Patients of Oral Submucous Fibrosis
Oral submucous fibrosis (OSF) is a chronic condition that causes stiffness of the oral tissues, reduced cheek flexibility, and difficulty opening the mouth. This randomized controlled clinical trial will compare the effects of intralesional autologous platelet-rich plasma (PRP) and triamcinolone acetate in patients with OSF. A total of 40 patients will be divided into two groups of 20. Group A will receive 1 ml of intralesional PRP, and Group B will receive 1 ml of intralesional triamcinolone acetate (40 mg/ml), once weekly for six weeks. Maximum interincisal distance and cheek flexibility will be measured before treatment, at six weeks, and at three months after treatment completion. The study will compare changes in these outcomes between the two groups to evaluate the effects of both treatments.
Read the detailed description
This randomized controlled clinical trial will be conducted in the outpatient department of Oral and Maxillofacial Surgery, Allama Iqbal Medical College/Jinnah Hospital, Lahore, Pakistan, following ethical approval.
A total of 40 patients clinically diagnosed with oral submucous fibrosis will be enrolled using purposive sampling and randomly allocated to two groups of 20 patients each. Group A will receive 1 ml of intralesional autologous platelet-rich plasma (PRP), while Group B will receive 1 ml of intralesional triamcinolone acetate (40 mg/ml). Injections will be administered once weekly for six consecutive weeks.
The primary clinical assessments will include maximum interincisal distance (MIID), measured in millimetres, and cheek flexibility, assessed using the method described by Mathur and Jha. Measurements will be recorded before treatment, at the sixth week, and at the third month after completion of treatment.
Eligible participants will be aged 18-60 years, of either gender, clinically diagnosed with OSF, and without previous treatment for the condition. Patients meeting the exclusion criteria specified in the study protocol will not be enrolled.
Participants will be advised to discontinue areca nut or betel nut consumption and perform mouth-opening exercises at home. Data will be analysed using SPSS version 23.0. Quantitative variables will be summarised using means and standard deviations, and appropriate statistical tests will be used to compare outcomes between the two groups. A p-value below 0.05 will be considered statistically significant.
- Conditions
- Oral Submucous Fibrosis
- Being tested
- Autologous Platelet-Rich Plasma, Triamcinolone Acetate
- Keywords
- Oral submucous fibrosis, Plate-let rich plasma, Triamcenolone acetate, Trismus, Mouth opening, Cheeky flexibility
- Medical subject headings
- Oral Submucous Fibrosis, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich PlasmaOther
Also called Biological
Freshly prepared autologous platelet-rich plasma (1 ml) administered via intralesional injection directly into fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally using a 1 ml insulin syringe once a week for 6 consecutive weeks.
Triamcinolone AcetateDrug
Triamcinolone acetate 1 ml (40 mg/ml) administered via intralesional injection directly into fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally using a 1 ml insulin syringe once a week for 6 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Autologous Platelet-Rich Plasma (PRP) | Experimental | Participants will receive 1 ml of intralesional autologous platelet-rich plasma (PRP) injected into the fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally once weekly for six consecutive weeks. Receives: Other: Autologous Platelet-Rich Plasma |
| Intralesional Triamcinolone Acetate | Active comparator | Participants will receive 1 ml of intralesional triamcinolone acetate (40 mg/ml) injected into the fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally once weekly for six consecutive weeks. Receives: Drug: Triamcinolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Interincisal Distance (MIID) / Trismus
Maximum interincisal distance (MIID) measured in millimeters (mm) using a calibrated ruler from the incisal edge of the maxillary central incisor to the incisal edge of the mandibular central incisor to evaluate improvement in trismus
Measured: Baseline, 6th week (after completion of 6 weekly injections), and 3rd month post-treatment
Cheek Flexibility
Cheek flexibility measured in millimeters (mm) using a flexible measuring ruler based on the Mathur and Jha method (V1 - V2), calculated as the difference between the distance from point A (one-third distance from corner of mouth to tragus) to point B (corner of mouth) when blowing cheeks fully (V1) versus at rest (V2).
Measured: Baseline, 6th week (after completion of 6 weekly injections), and 3rd month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Submucous FibrosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Esha Khalid, Allama Iqbal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914504
- Sponsor's protocol ID
- ERB193/ 8/29-08-2025/AIMC/JHL
- Acronym
- PRP OSF
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Intralesional Injection of Autologous Platelet-Rich Plasma Vs Triamcinolone Acetate on Trismus/Maximum Interincisal Distance and Cheek Flexibility in Patients of Oral Submucous Fibrosis
- ClinicalTrials.gov ID
- NCT07914504
- Acronym / sponsor ID
- PRP OSF / ERB193/ 8/29-08-2025/AIMC/JHL
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Oral submucous fibrosis, Plate-let rich plasma, Triamcenolone acetate, Trismus, Mouth opening, Cheeky flexibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Nov 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.
Oral submucous fibrosis (OSF) is a chronic condition that causes stiffness of the oral tissues, reduced cheek flexibility, and difficulty opening the mouth. This randomized controlled clinical trial will compare the effects of intralesional autologous platelet-rich plasma (PRP) and triamcinolone acetate in patients with OSF. A total of 40 patients will be divided into two groups of 20. Group A will receive 1 ml of intralesional PRP, and Group B will receive 1 ml of intralesional triamcinolone acetate (40 mg/ml), once weekly for six weeks. Maximum interincisal distance and cheek flexibility will be measured before treatment, at six weeks, and at three months after treatment completion. The study will compare changes in these outcomes between the two groups to evaluate the effects of both treatments.
Detailed description
This randomized controlled clinical trial will be conducted in the outpatient department of Oral and Maxillofacial Surgery, Allama Iqbal Medical College/Jinnah Hospital, Lahore, Pakistan, following ethical approval.
A total of 40 patients clinically diagnosed with oral submucous fibrosis will be enrolled using purposive sampling and randomly allocated to two groups of 20 patients each. Group A will receive 1 ml of intralesional autologous platelet-rich plasma (PRP), while Group B will receive 1 ml of intralesional triamcinolone acetate (40 mg/ml). Injections will be administered once weekly for six consecutive weeks.
The primary clinical assessments will include maximum interincisal distance (MIID), measured in millimetres, and cheek flexibility, assessed using the method described by Mathur and Jha. Measurements will be recorded before treatment, at the sixth week, and at the third month after completion of treatment.
Eligible participants will be aged 18-60 years, of either gender, clinically diagnosed with OSF, and without previous treatment for the condition. Patients meeting the exclusion criteria specified in the study protocol will not be enrolled.
Participants will be advised to discontinue areca nut or betel nut consumption and perform mouth-opening exercises at home. Data will be analysed using SPSS version 23.0. Quantitative variables will be summarised using means and standard deviations, and appropriate statistical tests will be used to compare outcomes between the two groups. A p-value below 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Autologous Platelet-Rich Plasma (PRP) | Experimental | Other: Autologous Platelet-Rich PlasmaParticipants will receive 1 ml of intralesional autologous platelet-rich plasma (PRP) injected into the fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally once weekly for six consecutive weeks. |
| Intralesional Triamcinolone Acetate | Active comparator | Drug: Triamcinolone AcetateParticipants will receive 1 ml of intralesional triamcinolone acetate (40 mg/ml) injected into the fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally once weekly for six consecutive weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 60 years
- Both male and female patients
- Patients clinically diagnosed with Oral Submucous Fibrosis (OSF) based on history of betel nut or areca nut chewing, palpable fibrous bands in buccal mucosa, restricted cheek flexibility, and reduced maximum interincisal distance
- Patients with no previous history of medical or surgical treatment for OSF
- Patients willing to participate and give informed written consent
Key exclusion criteria (7 listed)
- History of allergy to local anesthetics, PRP components, or corticosteroids
- Patients who underwent previous surgical treatment for OSF
- Patients with leukoplakic or erythroplakic changes of oral mucosa
- Patients tested positive for Hepatitis B or Hepatitis C
- Pregnant women and lactating mothers
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 |
|---|---|---|
| Autologous Platelet-Rich PlasmaAlso: BiologicalFreshly prepared autologous platelet-rich plasma (1 ml) administered via intralesional injection directly into fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally using a 1 ml insulin syringe once a week for 6 consecutive weeks. | Other | Intralesional Autologous Platelet-Rich Plasma (PRP) |
| Triamcinolone AcetateTriamcinolone acetate 1 ml (40 mg/ml) administered via intralesional injection directly into fibrotic bands along the buccal mucosa and retromolar trigone area bilaterally using a 1 ml insulin syringe once a week for 6 consecutive weeks. | Drug | Intralesional Triamcinolone Acetate |
Primary outcome
Maximum Interincisal Distance (MIID) / Trismus
Time frame: Baseline, 6th week (after completion of 6 weekly injections), and 3rd month post-treatment
Maximum interincisal distance (MIID) measured in millimeters (mm) using a calibrated ruler from the incisal edge of the maxillary central incisor to the incisal edge of the mandibular central incisor to evaluate improvement in trismus
Cheek Flexibility
Time frame: Baseline, 6th week (after completion of 6 weekly injections), and 3rd month post-treatment
Cheek flexibility measured in millimeters (mm) using a flexible measuring ruler based on the Mathur and Jha method (V1 - V2), calculated as the difference between the distance from point A (one-third distance from corner of mouth to tragus) to point B (corner of mouth) when blowing cheeks fully (V1) versus at rest (V2).
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 3 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma and Triamcinolone Acetate in people with Oral Submucous Fibrosis, run by Allama Iqbal Medical College at 1 site in Pakistan.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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.
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?
Contact Esha Khalid, BDS, Resident of OMFS (+92 321 4963558, khalidesha959@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Interincisal Distance (MIID) / Trismus (time frame: Baseline, 6th week (after completion of 6 weekly injections), and 3rd month post-treatment). The study lists 2 primary outcomes in all. 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 3 Nov 2026.