| CTRI Number |
CTRI/2022/09/045454 [Registered on: 13/09/2022] Trial Registered Prospectively |
| Last Modified On: |
01/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different treatment methods for treating lower jaw fracture with and without the use of computerized template. |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical and Radiological
Outcomes of Open Reduction & Internal Fixation of
Unilateral Subcondylar Fracture With and Without Use of
Virtual Surgical Planning and Surgical Template –
A Randomised Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ria Mukharjee |
| Designation |
PG student |
| Affiliation |
MGM dental college and hospital |
| Address |
MGM Dental College and Hospital
Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Pin 410 209.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8082651080 |
| Fax |
|
| Email |
mukherjeeria95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srivalli Natarajan |
| Designation |
HOD and guide |
| Affiliation |
MGM dental college and hospital |
| Address |
MGM Dental College and Hospital
Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Pin 410 209.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9769088803 |
| Fax |
|
| Email |
srivalli.shrikanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srivalli Natarajan |
| Designation |
HOD and guide |
| Affiliation |
MGM dental college and hospital |
| Address |
MGM Dental College and Hospital
Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Pin 410 209.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9769088803 |
| Fax |
|
| Email |
srivalli.shrikanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2,Sector 01(old 18 and 19),Kamothe, Navi Mumbai.
Pin 410 209. |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital
Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Pin 410 209 |
| Type of Sponsor |
Other [private dental college and hospital] |
|
|
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 |
| Ria Mukharjee |
MGM Dental College and Hospital |
MGM Dental College and Hospital
Junction of NH4 and Sion-Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Pin 410 209
Raigarh
MAHARASHTRA |
8082651080
mukherjeeria95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open reduction and internal fixation Without the Use of Virtual Surgical Planning and
fabrication of a Surgical Template.
|
Fixation of subcondylar fracture of mandible without using virtual surgical planning and fabrication of surgical template |
| Intervention |
Virtual Surgical Planning followed by fabrication of a
Surgical Template |
Fixation of subcondylar fracture of mandible using Virtual Surgical Planning followed by fabrication of a
Surgical Template. virtual surgical planning will be done pre operatively and the surgical guide will be only used intraoperatively for holding the fracture fragments and plate fixation then the guide will be removed. follow up will be done for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants in the age group of 18 – 60 years.
2. Participants with Unilateral Subcondylar fractures with more than 2 mm overlap and/or >10 degree angulation at the lower end of the condylar
fragment.
3. Participants with other concomitant fractures of Mandible which will be treated by Open reduction and internal fixation
4. Participants who have sustained fracture in the past two weeks.
5. Participants with a dentition complete enough to apply a stable Erich arch bar.
6. Participants willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Participants with history of uncontrolled diabetes mellitus, prolonged steroid therapy, compromised immunity and associated bone pathology.
2. Intracapsular Condylar fracture
3. Undisplaced condylar fracture.
4. Participants with history of previous Mandibular fractures or Osteotomies.
5. Subjects with bilateral condylar fracture.
6. Pregnant participants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the clinical outcomes such as
occlusion,inter incisal mouth opening, lateral excursion on
the contralateral side, lateral excursion on the fractured
site, protrusion, pain, edema and radiological
outcomes such as the degree of displacement, direction
of displacement, ramus height and the degree of
approximation of the fractured fragment. |
Clinical outcomes will be evaluated post operatively at 24hrs, 5 days, 3 weeks. All radiological outcomes will be evaluated at 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the intra operative time taken
for the completion of Open Reduction Internal Fixation of
Unilateral Subcondylar Fracture With and Without the
Use of Virtual Surgical Planning and Surgical Template. |
Intra-operative time :
Surgical parameter for evaluation will be based on
operative time recorded in minutes from the time of
exposure of the fracture upto the drilling of the last
screw |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/09/2022 |
| Date of Study Completion (India) |
30/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mandibular Condylar fractures are relatively common
accounting for 29% to 52% of all Mandibular fractures. There are various classification systems describing
Mandibular Condylar fractures based on the anatomical
position of fracture, degree of displacement and/ or
dislocation. There are two principal treatment modalities
for these fractures. Traditionally conservative
management was most preferred but in recent years
Open reduction & Internal fixation (ORIF) has become
the method of choice because it can provide better
functional and morphological outcomes in terms of
mouth opening, occlusal status and facilitates anatomic
reduction of Condyle. The challenges most often faced
during ORIF include difficulty in controlling the small
proximal fragment and achieving good stability. The
struggle to achieve good reduction and fixation often
prolongs the intraoperative time. Advent of Computed
tomography and 3D modelling have enabled better
understanding of the level of fracture, degree of
comminution, obliquity along the fracture line and hence
better treatment planning. Virtual surgical planning has
been recently introduced which has enabled surgeons to
perform the repositioning of the fragment virtually and
presumably select and precontour the appropriate fixation device thus reducing the intraoperative time and
increasing the accuracy of reduction and fixation. This
idea has been adopted following its proven efficacy in
treatment planning in reconstructive surgeries with Bone
grafting and free tissue transfers. A surgical template can
made with the help of virtual surgical planning which can
aid in holding the proximal fragment in position and help
in precise reduction, better control of the proximal
fragment and ensure placement of plates in the preplanned position and overall reduce the intraoperative
time.
The aim of the study is to evaluate whether the use of
virtual surgical planning and surgical template can
provide an anatomic reduction, require less
intraoperative time and ensure enhanced clinical and
radiological outcomes |