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

ConditionOral Submucous Fibrosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKarachi Medical and Dental College

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet-Rich Plasma (PRP) Injections

    Biological/Vaccine

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

  • Triamcinolone Acetonide

    Drug

    Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Alternating Triamcinolone + PRP TherapyActive comparator 2 interventions
Group B: Triamcinolone Alone TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karachi Medical and Dental College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: