An interventional study of Platelet-Rich Plasma (PRP) Injections and Triamcinolone Acetonide in Oral Submucous Fibrosis, sponsored by Karachi Medical and Dental College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Karachi Medical and Dental College · Not applicable, Interventional, and Treatment
Oral Submucous Fibrosis (OSF) is a chronic, progressive, potentially malignant disorder characterized by mucosal stiffness, trismus, and burning sensation. This interventional clinical trial evaluates the therapeutic effectiveness of alternating weekly intralesional Triamcinolone Acetonide (TA) and Platelet-Rich Plasma (PRP) injections compared to standard Triamcinolone therapy alone. The purpose is to determine whether sequential anti-inflammatory (TA) and regenerative (PRP) stimulation can produce superior clinical improvement in mouth opening, burning sensation, and mucosal flexibility compared to corticosteroid therapy alone.
Oral Submucous Fibrosis (OSF) is a chronic, irreversible fibro-elastic disorder of the oral mucosa associated with restricted mouth opening, burning sensation, impaired mastication, and decreased quality of life. Traditional management approaches include intralesional corticosteroids, physiotherapy, antioxidants, and more recently, regenerative therapies such as Platelet-Rich Plasma (PRP).
Triamcinolone Acetonide (TA) provides anti-inflammatory and anti-fibrotic effects by suppressing fibroblast activity and collagen deposition. PRP, an autologous concentrate of platelets and growth factors, has demonstrated potential in promoting angiogenesis, collagen remodeling, and mucosal regeneration. Alternating TA and PRP may theoretically combine the immediate anti-inflammatory benefits of TA with the long-term regenerative benefits of PRP, resulting in more effective improvement of OSF symptoms.
This study consists of two arms. In the control arm, participants will receive weekly intralesional Triamcinolone injections for 6 weeks. In the experimental arm, participants will receive Triamcinolone in Week 1, PRP in Week 2, followed by alternating TA and PRP injections for a total of 6 weeks. All participants will be instructed to perform standardized jaw physiotherapy exercises during the study period.
Primary outcomes include change in interincisal mouth opening (millimeters) and reduction in burning sensation using a Visual Analog Scale (VAS). Secondary outcomes include mucosal flexibility score, cheek rigidity grading, functional improvement during mastication and speech, and patient satisfaction.
This clinical trial aims to generate high-quality comparative evidence regarding whether an alternating TA-PRP protocol offers superior therapeutic outcomes compared to conventional corticosteroid therapy alone, thereby supporting advancement of regenerative treatment protocols for OSF within oral and maxillofacial clinical practice.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 40 is below the median of 63 across 840 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Karachi Medical and Dental College is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Compared within Fibrosis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinically diagnosed Oral Submucous Fibrosis (OSF), Stage II-IV using Haider et al. classification.
Age 18-65 years. Mouth opening ≤ 30 mm. Persistent burning sensation (VAS ≥ 3). Able and willing to comply with weekly therapy sessions. Provided written .
Exclusion Criteria:
Previous treatment with PRP, -rich Fibrin (PRF), , or combination therapy in the last 6 months.
Systemic diseases affecting wound healing (e.g., uncontrolled diabetes, severe anemia).
Current steroid therapy or therapy.
Oral lesions suspicious for or recurrent Oral Squamous cell carcinoma (OSCC).
Bleeding disorders or platelet count \<150,000.
Pregnant or breastfeeding women.
Known allergy to local anesthetics or triamcinolone.
Patients unwilling to stop areca nut/tobacco habits.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive alternating-week intralesional Triamcinolone (10 mg/mL) and Platelet-Rich Plasma therapy. Triamcinolone is given in Week 1, PRP in Week 2, and alternated weekly for a total of 6-8 sessions.
Biological: Platelet-Rich Plasma (PRP) Injections · Drug: Triamcinolone Acetonide
Patients will receive intralesional Triamcinolone acetonide (10 mg/mL) once weekly for 6-8 sessions as standard therapy.
Drug: Triamcinolone Acetonide
Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week.
Also known as: PRP
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Also known as: TA
Change in Mouth Opening (Interincisal Distance in mm)
Mouth opening will be measured using a digital caliper from incisal edge to incisal edge at baseline and at each follow-up visit. The primary endpoint is the change in interincisal distance from baseline to 8 weeks and 12 weeks.
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Burning Sensation (VAS Score 0-10)
Burning sensation will be assessed using the Visual Analog Scale (VAS), where 0 indicates no burning and 10 indicates the worst possible burning.
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Clinical Grade of OSMF
Oral Submucous Fibrosis (OSF) severity will be assessed using a standardized clinical grading system that evaluates mouth opening, fibrous banding, mucosal texture, and burning sensation. Grades range from Grade I (mild) to Grade IV (severe). Higher grades indicate more advanced disease. Improvement or worsening will be determined by comparing baseline and Week 12 assessment
Time frame: Baseline and Week 12
Change in Cheek Flexibility (mm)
Cheek flexibility will be measured using Mathur and Jha method at baseline and follow-up visits.
Time frame: Baseline, Week 8, Week 12
Incidence of Treatment-Related Adverse Events
All adverse events such as swelling, pain, ulceration, infection, or allergy will be recorded throughout the study period.
Time frame: Up to 12 weeks
Plan to share: No — Individual participant data (IPD) will not be shared because the dataset will be used for future analyses, internal audits, and subsequent publications by the study team. Data will remain confidential and securely stored according to institutional policy.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma
Karachi Medical and Dental College