FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064106 [Registered on: 13/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Local application of drug 5- FLUOROURACIL as a Medication THERAPY following removal of tumour called AMELOBLASTOMA 
Scientific Title of Study   5- Fluorouracil as a novel adjunctive therapy for conservative management of Ameloblastoma – a randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Manekar 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Department of OMFS GDCH GMC campus Medical Square Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9823077626  
Fax    
Email  varshamanekar67@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Shetty 
Designation  Post graduate 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Department of OMFS GDCH GMC campus Medical Square Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  7710978206  
Fax    
Email  shettypriyanka424@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Shetty 
Designation  Post graduate 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Department of OMFS GDCH GMC campus Medical Square Nagpur


MAHARASHTRA
440003
India 
Phone  7710978206  
Fax    
Email  shettypriyanka424@gmail.com  
 
Source of Monetary or Material Support  
Prinicipal Investigator, Department of OMFS, GDCH Nagpur 
 
Primary Sponsor  
Name  Dr Priyanka Shetty 
Address  Department of OMFS, GDCH, GMC campus, Medical square, Nagpur 
Type of Sponsor  Other [Individual Sponser] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanka Shetty  Department of OMFS  Room no. 116/106, 1st floor, Department of OMFS GDCH GMC campus Medical Square Nagpur
Nagpur
MAHARASHTRA 		 7710978206

shettypriyanka424@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, GDCH, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 gel + 5% 5-FU solution (500mg/10 ml) with the end exposed and the cavity was regularly changed and packed for 7 days and after that the cavity was sutured back. 
Comparator Agent  Modified Carnoys Solution  After enucleation, the cavity was packed with tape gauze soaked with modified carnoys solution for 3 mins and then the pack was removed and the cavity was sutured back 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Nerve Paresthesia
2) Radiographic Healing of lesion
3) Recurrence of lesion 		 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 Outcome  
Outcome  TimePoints 
Volumetric Analysis of the cavity following excision.  Pre-op - S0
6 months post -op - S1
12 months post-op - S2 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="1"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Ameloblastoma is a benign aggressive lesion which has been known to expand beyond its margins and cause bone perforation and affect adjacent structures as well causing facial swelling.
Various treatment modalities have been suggested to manage such a conditionm including currettage, decompression and enucleation with adjuvant therapies like carnoy’s solution, cryotherapy and electrocautery.
All of these treatment modalities couldn’t limit the recurrecne of these lesions. Resection is the only modality which offers least amount of recurrence but it causes facial disfigurement which requires reconstruction which again is an expensive procedure.
Recent studies suggested the connection between sonic hegdehog pathway and ameloblastoma and downregulating effect of 5-FU on the sonic hegdehog pathway.
5-FU is a chemotherapeutic drug and has found to have been effective in the management of Ameloblastic carcinoma and Malignant Ameloblastona.
There is a scarcity of literature discussing the rationality of using 5-FU in the conservative management of Ameloblastomna.
Furtehr studies are required to study the effects of 5-FU in the conservative management of Ameloblastoma of the jaws and the protocol to use 5-FU in the management of Ameloblastoma.
 
Close