An interventional study of Autologous Platelet-Rich Plasma and Triamcinolone Acetate in Oral Submucous Fibrosis, sponsored by Allama Iqbal Medical College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Allama Iqbal Medical College · Not applicable, Interventional, and Treatment
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.
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.
92 studies on the registry are indexed under Trismus; 17 are open to participants now.
This study's planned enrollment of 40 is below the median of 48 across 85 interventional studies indexed under Trismus.
Browse Trismus studies →Allama Iqbal Medical College is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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.
Other: Autologous Platelet-Rich Plasma
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.
Drug: Triamcinolone Acetate
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.
Also known as: Biological
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.
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
Time frame: 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).
Time frame: Baseline, 6th week (after completion of 6 weekly injections), and 3rd month post-treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2029, 30 months later.
Of 48 non-industry interventional studies with no phase under Trismus, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 21. This study's planned 30 months is above that.
Counting every sponsor, half of 49 studies reached it within 9 months; a quarter within 5 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Allama Iqbal Medical College