| CTRI Number |
CTRI/2025/03/083337 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Results of a Modified Surgical Approach for Treating Zygomatic Bone Fractures with Orbital Floor Damage |
|
Scientific Title of Study
|
Assessment of outcomes with Y modification of transconjunctival approach for zygomatic complex fractures with Orbital floor discontinuity |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rishabh Kasrija |
| Designation |
Postgraduate student |
| Affiliation |
Jagadguru Sri Shivarathreeshwara dental college and hospital |
| Address |
Department of Oral Surgery
Room no 09 Jagadguru Sri Shivarathreeshwara Dental College and Hospital Bannimantap Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9530575155 |
| Fax |
|
| Email |
rkasrija018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishabh Kasrija |
| Designation |
Postgraduate student |
| Affiliation |
Jagadguru Sri Shivarathreeshwara dental college and hospital |
| Address |
Department of Oral Surgery
Room no 09 Jagadguru Sri Shivarathreeshwara Dental College and Hospital Bannimantap Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9530575155 |
| Fax |
|
| Email |
rkasrija018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujeeth Kumar Shetty |
| Designation |
Professor |
| Affiliation |
Jagadguru Sri Shivarathreeshwara Dental College and Hospital |
| Address |
Department of Oral Surgery
Room no 09 Jagadguru Sri Shivarathreeshwara Dental College and Hospital Bannimantap Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9530575155 |
| Fax |
|
| Email |
shettymaxfax@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jagadguru Sri Shivarathreeshwara Dental College and Hospital bannimantap, mysore ,karnataka ,India 570015 |
|
|
Primary Sponsor
|
| Name |
Jagadguru Sri Shivarathreeshwara Dental College |
| Address |
Jagadguru Sri Shivarathreeshwara bannimantap mysore karnataka |
| Type of Sponsor |
Other [Dental College] |
|
|
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 Rishabh Kasrija |
Jagadguru Sri Shivarathreeshwara Dental College and Hospital |
Department of Oral Surgery
Room no 09, Bannimantap Mysore 570015
Mysore
KARNATAKA |
9530575155
rkasrija018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College & Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
to assess the outcomes of Y modification of transconjunctival incision |
The purpose of researching the "Y" modification of the transconjunctival approach for the management of zygomatic complex fractures is to evaluate its effectiveness in treating ZMC type of fractures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with orbito-zygomatico-maxillary complex fractures (class III to VII according to Rowe and Killey’s classification 1968) requiring surgical access by trans-conjunctival approach with Y -modification, reduction & fixation at both infraorbital margins and fronto-zygomatic suture.
2.Patients without existing laceration in the periorbital region.
3.Patients who consent to be part of the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients medically contraindicated for surgery.
2.Patients with infected fracture of the orbito-zygomatico-maxillary complex region.
3.Patients with undisplaced fracture not warranted for surgical intervention.
4.Comminuted ZMC fractures.
5.Patients with eye injury or with impaired visual acquity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient and surgeon satisfaction analysis with Y modification of transconjunctival incision |
Follow up period for one month and third month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications associated with Y modification of transconjunctival incision |
At 3 months & 6 months interval |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/03/2026 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rkasrija018@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 27-12-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The transconjunctival approach for zygomaticomaxillary complex (ZMC) fractures has become a popular technique due to its minimal invasiveness and favorable aesthetic outcomes. However, the traditional transconjunctival approach has limitations in providing adequate visualization and reduction of complex ZMC fractures, leading to suboptimal results and complications. Therefore, we hypothesize that modification of the transconjunctival approach by incorporating Y technique (e.g. endoscope-assisted, intraoral incision, etc.) can improve visualization and reduction of complex ZMC fractures, resulting in better functional and aesthetic outcomes, and reduced complications |