Comparing the Efficacy of Platelet-Rich Plasma Versus Methylprednisolone in the Intra-lesional Management of Oral Submucous Fibrosis Patients at National Hospital, Galle: A randomized clinical trial

Comparing the Efficacy of Platelet-Rich Plasma Versus Methylprednisolone in the Management of Oral Submucous Fibrosis Patients at National Hospital, Galle: A Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2026/015

Enrollment

Unknown

Registered

2026-06-26

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Submucous Fibrosis

Interventions

1. Study setting - Oral and Maxillofacial Surgical Unit at National Hospital, Galle 2. Randomization: Participants will be randomly assigned using a simple random sampling method rather than convenie

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-65 years and any gender Clinically and histologically confirmed Oral Submucous Fibrosis (OSMF) Stage 2 (moderate OSMF cases with mouth opening between 20mm and 35mm) No prior Oral Submucous Fibrosis (OSMF) treatment

Exclusion criteria

Exclusion criteria: Patients with coagulation disorders History of allergy to corticosteroids or PRP Pregnant or lactating women Patients currently undergoing treatment for Oral Submucous Fibrosis (OSMF)

Design outcomes

Primary

Measure	Time frame
Improvement in mouth opening (measured precisely as the change in maximum inter-incisal distance in millimeters with a Vernier caliper). [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.]	—

Secondary

Measure	Time frame
Reduction in pain - The following Visual Analogue Scale (VAS) which is a validated tool to measure pain will be used. A horizontal line which is 100mm in length will be used with attached to word descriptions at each end; “Not hurting” or “no pain” to “hurting a whole lot” or “severe pain”. The patients will be asked to mark the line point with “X” at the point that they feel represents their pain at that moment. The pain severity will be determined by measuring the distance from the left end of the line to the “X” in mm.” [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.] Patient satisfaction: A horizontal line of 100-mm long will be used for this purpose. At the beginning and at the end, there will be two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). The patient will be requested to rate his/her satisfaction by making a vertical mark on the 100-mm line. The measurement in millimetres will be converted to the same number of points ranging from 0 to 100 points. The exact question will be “Are you satisfied with your treatment?” A standard explanation of how to fill in the VAS form will be mentioned beneath the VAS horizontal line. [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.] Reduction in burning sensation (Visual Analogue Scale scores) [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.] Burning sensation (Visual Analogue Scale scores) [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.]	—

Measure

Time frame

Reduction in pain - The following Visual Analogue Scale (VAS) which is a validated tool to measure pain will be used. A horizontal line which is 100mm in length will be used with attached to word descriptions at each end; “Not hurting” or “no pain” to “hurting a whole lot” or “severe pain”. The patients will be asked to mark the line point with “X” at the point that they feel represents their pain at that moment. The pain severity will be determined by measuring the distance from the left end of the line to the “X” in mm.” [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.] Patient satisfaction: A horizontal line of 100-mm long will be used for this purpose. At the beginning and at the end, there will be two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). The patient will be requested to rate his/her satisfaction by making a vertical mark on the 100-mm line. The measurement in millimetres will be converted to the same number of points ranging from 0 to 100 points. The exact question will be “Are you satisfied with your treatment?” A standard explanation of how to fill in the VAS form will be mentioned beneath the VAS horizontal line. [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.] Reduction in burning sensation (Visual Analogue Scale scores) [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.] Burning sensation (Visual Analogue Scale scores) [Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks.]

—

Countries

Sri Lanka

Contacts

Public ContactDr. Dayanath Kumara Dias

Consultant in Oral and Maxillofacial Surgery

dkdias60@gmail.com-

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026