Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis (RegenOSF)

December 10, 2025 updated by: Madiha Khan, Karachi Medical and Dental College

Clinical Efficacy of Alternating Intralesional Triamcinolone Acetonide and Platelet-Rich Plasma Compared to Triamcinolone Alone in Patients With Oral Submucous Fibrosis: A Two-Arm Interventional Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 71510
        • Abbasi Shaheed Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Madiha Khan, BDS, MS
        • Sub-Investigator:
          • Aisha Zafar, BDS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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 informed consent.

Exclusion Criteria:

Previous treatment with PRP, Platelet-rich Fibrin (PRF), corticosteroid, or combination therapy in the last 6 months.

Systemic diseases affecting wound healing (e.g., uncontrolled diabetes, severe anemia).

Current steroid therapy or immunosuppressive therapy.

Oral lesions suspicious for malignancy 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alternating Triamcinolone + PRP Therapy
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
Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week.
Other Names:
  • PRP
Drug: Triamcinolone Acetonide
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Other Names:
  • TA
Active Comparator: Triamcinolone Alone Therapy
Patients will receive intralesional Triamcinolone acetonide (10 mg/mL) once weekly for 6-8 sessions as standard therapy.
Drug: Triamcinolone Acetonide
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Other Names:
  • TA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mouth Opening (Interincisal Distance in mm)
Time Frame: Baseline, Week 4, Week 8, Week 12
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.
Baseline, Week 4, Week 8, Week 12
Change in Burning Sensation (VAS Score 0-10)
Time Frame: Baseline, Week 4, Week 8, Week 12
Burning sensation will be assessed using the Visual Analog Scale (VAS), where 0 indicates no burning and 10 indicates the worst possible burning.
Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Grade of OSMF
Time Frame: Baseline and Week 12
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
Baseline and Week 12
Change in Cheek Flexibility (mm)
Time Frame: Baseline, Week 8, Week 12
Cheek flexibility will be measured using Mathur and Jha method at baseline and follow-up visits.
Baseline, Week 8, Week 12
Incidence of Treatment-Related Adverse Events
Time Frame: Up to 12 weeks
All adverse events such as swelling, pain, ulceration, infection, or allergy will be recorded throughout the study period.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karachi Medical and Dental College

Investigators

  • Study Chair: Sufyan Ahmed, BDS, FCPS, Karachi Medical and Dental College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Khan M, Ahmed S, Faraz A, Ali Z, Khan S, Iqbal M. Comparison Between Treatment of Oral Submucous Fibrosis with Intralesional Triamcinolone Injection Versus Platelet-Rich Plasma. Journal of Population Therapeutics and Clinical Pharmacology. 2025;32(4):166-172.
  • Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of Platelet-Rich Plasma and regenerative potential in tissue healing. Am J Sports Med. 2009;37(11):2259-2272. PMID: 19088268.
  • Tilakaratne WM, Klinikowski MF. Intralesional corticosteroid injection as a treatment modality for oral submucous fibrosis. J Oral Pathol Med. 2016;45(3):162-168. PMID: 27422421.
  • Saraf K, Gaur A, Thomas R. Efficacy of Platelet-Rich Plasma injections in Oral Submucous Fibrosis: A Prospective Clinical Study. Dent Res Dent Clin Dent Prospects. 2021;15(4):275-280. PMID: 34912641.
  • OSF Singh S, Misra N. Comparative evaluation of intralesional platelet-rich plasma and intralesional corticosteroid in management of oral submucous fibrosis. J Oral Maxillofac Pathol. 2020;24(1):121-126. PMID: 33584414.
  • Ali H, Ahmed S, Raza SH. Effect of intralesional injection of triamcinolone acetonide in oral submucous fibrosis. Journal of Surgery Pakistan. 2019;24(4):181-185.
  • Haider SM, Merchant A, Fida M. Clinical grading of oral submucous fibrosis: A practical classification for patient severity assessment. Journal of Pakistan Dental Association. 2016;25(4):147-152.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK_OSF_ALTTA_PRP_2025
  • KMDC/OMFS/OSF-CombTherapy/2025 (Other Identifier: Karachi Medical and Dental College)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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