5FU injection to increase Mouth opening

Does 5-Flurouracil increase the mouth opening in patients with Oral Submucous Fibrosis? A prospective cohort pilot study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/054702

Enrollment

Registered

2023-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Interventions

Intervention1: Intralesional injection of 5-Flurouracil: i. The usual dosage of 5-FU in intralesional injections of Keloids is at 10mg/ml. Hence we intend to use the same dosage in the management of O

Eligibility

Inclusion criteria

Inclusion criteria: i. Patients with oral submucous fibrosis (OSMF) ii. Pre operative mouth opening of less than 20 mm iii. Age: 18 years to 60 years

Exclusion criteria

Exclusion criteria: i. Patients with previous history of treatment for OSMF ii. Documented history of deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) iii. Patients who are continuing areca nut chewing iv. Pregnancy

Design outcomes

Primary

Measure	Time frame
Maximum interincisal opening (MIO)Timepoint: Preoperative, 1 Month, 3 Month and 6 Month	—

Secondary

Measure	Time frame
Biopsy findingsTimepoint: Preoperative and 6 Month;Burning Sensation in VAS scaleTimepoint: Preoperative, 1 Month, 3 Month and 6 Month;Changes in the Mucosal findingsTimepoint: Preoperative, 1 Month, 3 Month and 6 Month;VAS Scale for Tolerance to Spicy FoodTimepoint: Preoperative, 1 Month, 3 Month and 6 Month	—

Countries

India

Contacts

Public ContactSanthosh Rao

All India Institute of Medical Sciences Raipur

santhosh@aiimsraipur.edu.in9981525599

Outcome results

None listed

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