| CTRI Number |
CTRI/2026/02/104685 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of two treatments used after removing a jaw cyst, the intervention being a refrigerant spray named Endrofrost to see which one works better in preventing the cyst from coming back and also the pain perception after the surgery |
|
Scientific Title of Study
|
Comparative Evaluation of the Effectiveness of Gas Combination Cryotherapy (using a refrigerant spray of propane, butane and isobutane) and 5-Fluorouracil Following Enucleation and Curettage in Management of Odontogenic Keratocyst |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashit Upadhyay |
| Designation |
Post-graduate student |
| Affiliation |
Nair Hospital Dental College |
| Address |
55, Dr. Anandrao Nair Marg, Mumbai Central
Department of Oral & Maxillofacial Surgery, Room no. 107, Nair hospital dental college
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9415152222 |
| Fax |
|
| Email |
prashit8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trupti Gandhewar |
| Designation |
Associate Professor |
| Affiliation |
Nair Hospital Dental College |
| Address |
55, Dr. Anandrao Nair Marg, Mumbai Central
Room no. 107, Department of Oral & Maxillofacial Surgery, Nair hospital dental college
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
betuprashit10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashit Upadhyay |
| Designation |
Post-graduate student |
| Affiliation |
Nair Hospital Dental College |
| Address |
55, Dr. Anandrao Nair Marg, Mumbai Central
Room no. 107, Department of Oral & Maxillofacial Surgery, Nair hospital dental college
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9415152222 |
| Fax |
|
| Email |
prashit8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prashit Upadhyay |
| Address |
55, Dr. Anandrao Nair Marg, Nair Hospital Dental College, Mumbai Central - 400008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashit Upadhyay |
Nair Hospital Dental College |
Room no. 107, Department of Oral & Maxillofacial surgery, Nair hospital dental college, 55, Anandrao marg, Opposite Maratha Mandir, Mumbai Central - 400008
Mumbai
MAHARASHTRA |
09415152222
prashit8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nair Hospital Dental College - Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M274||Other and unspecified cysts of jaw, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
5-Fluorouracil |
It is a cytotoxic chemotherapy medication (antimetabolite) |
| Intervention |
Gas Combination Cryotherapy agent ENDOFROST |
It is a refrigerant spray that goes upto -50 degree celcius with the complete procedure that involves 1 minute cooling time followed by 2-3 minutes thawing time for a total of 3 cycles |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Any patient with a cystic lesion involving the maxilla and/or mandible in which histopathology was suggestive of KCOT/OKC pre-operatively.
2. Patients presenting with one or multiple cysts.
3. Age greater than 13
4. Minimum of 8 mm vital bone is left from the nearest border of maxilla or mandible
5. Patients with well-controlled systemic conditions. |
|
| ExclusionCriteria |
| Details |
1. Patients who refused to give consent for being included in the study.
2. Lesions with a risk of pathological bone fracture.
3. Patients with prior trigeminal nerve injury and existing paresthesia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Final bone formation
2. Reduction in swelling
3. Nerve paraesthesia |
1 week, 2 weeks, 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
The
study will be a single-blinded, randomized, hospital-based clinical study.
The
intervention study will be carried out on patients visiting the Oral and
Maxillofacial Surgery outpatient department,
undergoing the enucleation and
curettage of OKC.
The subjects who are willing to participate in study will be
selected serially during
the study period
as per the
inclusion and exclusion criteria.
|
ASSESSMENT OF
·
1. PAIN
·
2. WOUND DEHISCENCE, INFECTION
AND NECROSIS
·
3. SOFT TISSUE HEALING
·
4. HARD TISSUE HEALING
·
5. RECURRENCE
·
6. NEUROSENSORY DEFICIT
·
Will be done by the Primary
Investigator & the Co-Investigators
|
Follow-up
on post-operative days 1st day, 7th
day, 14th, 1 month, 3
months & 8 months.
Randomization of participants into two groups
will be carried out as per computer generated
list of random numbers into one of two as group A and group B. Participant
will not be aware of the group in which he/she is included.
· GROUP A (Control Group): Patients having OKCs who receive 5-Fluorouracil
as the adjunctive therapy
· GROUP B (Study Group): Patients having OKCs who receive Gas
Combination Cryotherapy (GCC) as the adjunctive therapy
Willing participants who meet the inclusion criteria will be
informed about the benefits and risks associated with the procedure after
which a written, valid, informed consent
will be taken from all the patients.
|
|