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

NCT07277998 | Not Yet Recruiting

• 2 other identifiers: MK_OSF_ALTTA_PRP_2025KMDC/OMFS/OSF-CombTherapy/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Submucous Fibrosis

Keywords

Triamcinolone acetonide; Platelet-rich plasma; Regenerative therapy; Oral mucosal disorders; Fibrosis; OSF; Intralesional therapy; Oral and maxillofacial surgery; Steroid injection; Mouth opening; Burning sensation; Oral precancerous lesions; Stem cell mediated healing; Collagen remodeling; Areca nut; Trismus; Limited mouth opening; LMO; BMS; OMFS; Regenerative dentistry; Oral surgery; PRP

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (3)

• Change in Clinical Grade of OSMF

  Baseline and Week 12

• Change in Cheek Flexibility (mm)

  Baseline, Week 8, Week 12

• Incidence of Treatment-Related Adverse Events

  Up to 12 weeks

Study Arms (2)

Alternating Triamcinolone + PRP Therapy

ACTIVE COMPARATOR

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

Triamcinolone Alone Therapy

ACTIVE COMPARATOR

Patients will receive intralesional Triamcinolone acetonide (10 mg/mL) once weekly for 6-8 sessions as standard therapy.

Drug: Triamcinolone Acetonide

Interventions

Platelet-Rich Plasma (PRP) Injections BIOLOGICAL

Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week.

Also known as: PRP

Alternating Triamcinolone + PRP Therapy

Triamcinolone Acetonide DRUG

Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.

Also known as: TA

Alternating Triamcinolone + PRP Therapy; Triamcinolone Alone Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karachi Medical and Dental College: lead

Study Sites (1)

Abbasi Shaheed Hospital

Karachi, Sindh, 71510, Pakistan

Location

Related Publications (7)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

Related Links

• Published comparative study on PRP and TA therapy for Oral Submucous Fibrosis by the Principal Investigator.
• Institutionally developed OSF clinical grading system used in this trial.
• Steroid-based management study of Oral Submucous Fibrosis conducted at the same institution.

MeSH Terms

Conditions

Oral Submucous Fibrosis; Fibrosis; Paresthesia; Trismus

Interventions

Injections; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Spasm; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sufyan Ahmed, BDS, FCPS

  Karachi Medical and Dental College

  STUDY CHAIR

Central Study Contacts

Madiha Khan, BDS, MS

CONTACT

+923350-250691; Dr.khanmadiha@gmail.com

Aisha Faraz, BDS, MS

CONTACT

+92333096619; Aishazafar212@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel assignment comparing alternating-week Triamcinolone + PRP therapy vs standard single-agent therapy

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 11, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)