Home » Trials » SLCTR/2026/015
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.
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SLCTR Registration Number
SLCTR/2026/015
Date of Registration
The date of last modification
Jun 26, 2026
Scientific Title of 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.
Public Title of Trial
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
Disease or Health Condition(s) Studied
Oral Submucous Fibrosis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1334-4134
Any other number(s) assigned to the trial and issuing authority
2024/P/081(05.12.2024)
What is the research question being addressed?
Is there a difference in the comparative efficacy of Platelet-Rich Plasma (PRP) versus Methylprednisolone in the intra-lesional management of Oral Submucous Fibrosis (OSMF) Patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study setting - Oral and Maxillofacial Surgical Unit at National Hospital, Galle
Randomization: Participants will be randomly assigned using a simple random sampling method rather than convenient sampling. A computer-generated randomization sequence with a 1:1 allocation ratio will be prepared by an independent statistician not involved in participant recruitment or intervention delivery. Allocation concealment will be ensured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE). Each envelope will contain the group assignment and will be opened sequentially by the Principal Investigator only after obtaining informed consent and enrolling the participant into the study. This process will prevent selection bias and ensure proper allocation concealment.
Intervention Group A: (Standard therapy) The standard therapy is used as the control group in the beginning. Control group treatment procedure - 1ml methyl prednisolone + 0.5ml lignocaine with adrenaline 1:80,000 will be mixed together and injected to fibrous bands of patients. Lignocaine will be added to reduce pain. 1ml of methyl prednisolone solution contains 40 mg of methyl prednisolone.
Group B: Patients will receive intra-lesional injections of PRP at baseline and then at 2-weeks intervals for three months of six cycles.
Group B. 18ml of blood will be drawn for preparation of PRP with 2ml citrate solution for the patients in the intervention group. The blood will be mixed with 2 ml of citrate dextrose solution (an anticoagulant agent) and processed in a centrifuge machine for 6 minutes at a speed of 3200 Rpm. The same person will draw blood from all the participants assigned to Group B to minimize bias. Approximately 10ml of PRP will be produced by 18ml of blood. PRP will be prepared at each 2 weekly visits of each patient. It is not done only once and the PRP sample will not be preserved for future administrations
The intra-lesional injections will be administered by a qualified staff member attached to the Oral and Maxillofacial unit at National Hospital Galle. The same person will be administering injections for all the participants of the trial to minimize bias.
Since the participants will not be blinded, the care of participants such as giving habit cessation advice and strict oral hygiene improvement, frequency of follow-up and management of complications will be standardized for both groups.
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
Patients with coagulation disorders History of allergy to corticosteroids or PRP Pregnant or lactating women Patients currently undergoing treatment for Oral Submucous Fibrosis (OSMF)
Primary outcome(s)
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1.
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 outcome(s)
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1.
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. ] |
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2.
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. ] |
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3.
Reduction in burning sensation (Visual Analogue Scale scores) |
[ Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks. ] |
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4.
Burning sensation (Visual Analogue Scale scores) |
[ Baseline assessment and follow-up assessments will be carried out at 4, 8, and 12 weeks. ] |
Target number/sample size
24 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2026-07-01
Anticipated end date
2026-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self-funded
Regulatory approvals
Pending
Status
Approved
Date of Approval
2025-07-31
Approval number
2024/P/081(05.12.2024)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Telephone: | The Administrative Officer Office: 0912232288 Ext: 161 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. Dayanath Kumara Dias
Consultant in Oral and Maxillofacial Surgery
National Hospital Galle, Sri Lanka
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0777801859
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dkdias@sltnet.lk
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Contact Person for Public Queries
Dr. Dayanath Kumara Dias
Consultant in Oral and Maxillofacial Surgery
National Hospital Galle, Sri Lanka
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0777801859
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dkdias@sltnet.lk
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Primary study sponsor/organization
Dr. Dayanath Kumara Dias
Consultant in Oral and Maxillofacial Surgery
National Hospital Galle, Sri Lanka
0777801859
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dkdias@sltnet.lk
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Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
N/A
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
