A Study Comparing Medicines and Surgery for Treating Mouth Stiffness in People with Oral Submucous Fibrosis

NOVEL INTERVENTIONS IN OSMF TREATMENT: COMPARING PHARMACOLOGICAL AND SURGICAL MODALITIES THROUGH A TRIPLE-ARM CLNICAL TRIAL - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089097

Enrollment

Registered

2025-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis Health Condition 2: K135- Oral submucous fibrosis Health Condition 3: K135- Oral submucous fibrosis Health Condition 4: K135- Oral submucous fibrosis

Interventions

Intervention1: Intralesional Triamcinolone Hyaluronidase injections, Intralesional Platelet Rich Plasma.: Patients will be administered Intralesional Triamcinolone Hyaluronidase injections weekly for

Eligibility

Inclusion criteria

Inclusion criteria: Patients with an interincisal mouth opening between 15 to 25mm Biopsy proven OSMF No systemic disorders Patients with hemoglobin greater than 10g per dl and platelet count greater than 150000 per microlitre Patients aged between 18 to 53 years Patients who have quit tobacco use more than 6 months ago Patients willing to take part in the study Available for the long term follow up

Exclusion criteria

Exclusion criteria: Patients with an interincisal mouth opening less than 15 mm Patients with age less than 18 years and greater than 53 years Currently chewing tobacco or less than 6 months of quitting of habit Smokers Patients having allergy to local drugs Patients who have undergone any kind of treatment for OSMF previously Patients with an uncontrolled systemic illness Patients with altered hemodynamic values Patients who have undergone treatment for malignancy any radiotherapy or chemotherapy Women who are pregnant lactating or taking oral contraceptives Patients who have reduced mouth opening due to reasons other than OSMF Patients who are not willing to participate in the study

Design outcomes

Primary

Measure	Time frame
Mouth opening in mm Reduction in the burning sensation will be assessed by visual analogue scaleTimepoint: Mouth opening in mm Reduction in the burning sensation will be assessed by visual analogue scale	—

Secondary

Measure	Time frame
Quality of life using Oral Health Impact Profile 14 QuestionnaireTimepoint: Follow up for more than 12 months	—

Countries

India

Contacts

Public ContactDr GAGANDEEP SINGH RANDHAWA

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY GOVERNMENT DENTAL COLLEGE AND HOSPITAL JAMNAGAR

randhawa@yahoo.com9669051622

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026