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Local application of drug 5- FLUOROURACIL as a Medication THERAPY following removal of tumour called AMELOBLASTOMA

5- Fluorouracil as a novel adjunctive therapy for conservative management of Ameloblastoma – a randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064106
Enrollment
30
Registered
2024-03-13
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: After enucleation of the tumor the walls of the cavity were coated with 5% 5-Fu cream and the cavity was packed with tape gauze soaked with glycerine + 5% lignocaine

Sponsors

Dr Priyanka Shetty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All the Histopathologically diagnosed cases of Ameloblastoma reporting in OPD. 2) All patients willing and fit for surgery. 3) All the cases who are undergoing treatment for the 1st time.

Exclusion criteria

Exclusion criteria: 1) Patients with diagnosis other than Ameloblastoma reporting in OPD 2) Patients unwilling and unfit for surgery. 3) Patients who are lost to follow up. 4) Recurrent cases or Aggressive Case of Ameloblastoma.

Design outcomes

Primary

MeasureTime frame
1) Nerve Paresthesia 2) Radiographic Healing of lesion 3) Recurrence of lesionTimepoint: 1) Nerve Paresthesia - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. 2) Radiographic Healing of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. 3) Recurrence of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years

Secondary

MeasureTime frame
Volumetric Analysis of the cavity following excision.Timepoint: 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