A study on local application of drug named 5-fluorouracil after removal of cyst by the name of Odontogenic keratocyst in jaws

5- FLUOROURACIL AS A NOVEL ADJUNCTIVE THERAPY FOR CONSERVATIVE MANAGEMENT OF ODONTOGENIC KERATOCYST – A RANDOMIZED CONTROL TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063854

Enrollment

Registered

2024-03-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 5% 5-Fluorouracil: 5% 5-FU cream is applied to the walls of the cavity after enucleation of the lesion and tape gauze pack consisting of combination of glycerine + 5% lignocaine gel + (

Eligibility

Inclusion criteria

Inclusion criteria: 1) All the histopathologically diagnosed cases of Odontogenic Keratocyst reporting in OPD. 2) All patients willing and fit for surgery. 3) All the cases who are undergoing treatment for the 1st time as well as the recurrent cases

Exclusion criteria

Exclusion criteria: 1) Patients with diagnoses other than Odontogenic Keratocyst reporting in OPD 2) Patients unwilling and unfit for surgery. 3) Patients who are lost to follow up.

Design outcomes

Primary

Measure	Time frame
1) Nerve Paresthesia 2) Healing of Cyst 3) Radiographic Recurrence of CystTimepoint: 1) Nerve Paresthesia - pre-op,post-op, 15 days, 1 month, 3 months, 6 months, 1 yr, 1yr 6 months, 2 years. 2) Healing of Cyst - pre-op,post-op, 15 days, 1 month, 3 months, 6 months, 1 yr, 1yr 6 months, 2 years. 3) Radiographic Recurrence of Cyst - pre-op,post-op, 15 days, 1 month, 3 months, 6 months, 1 yr, 1yr 6 months, 2 years.	—

Measure

Time frame

1) Nerve Paresthesia 2) Healing of Cyst 3) Radiographic Recurrence of CystTimepoint: 1) Nerve Paresthesia - pre-op,post-op, 15 days, 1 month, 3 months, 6 months, 1 yr, 1yr 6 months, 2 years. 2) Healing of Cyst - pre-op,post-op, 15 days, 1 month, 3 months, 6 months, 1 yr, 1yr 6 months, 2 years. 3) Radiographic Recurrence of Cyst - pre-op,post-op, 15 days, 1 month, 3 months, 6 months, 1 yr, 1yr 6 months, 2 years.

—

Secondary

Measure	Time frame
Volumetric Analysis of the cystTimepoint: Pre-op - S0 6 months post op - S1 12 months post op - S2	—

Countries

India

Contacts

Public ContactDr Priyanka Shetty

Government Dental College and Hospital, Nagpur

shettypriyanka424@gmail.com7710978206

Outcome results

None listed

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