| CTRI Number |
CTRI/2023/01/049197 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of change in sequence in fixation of Lower jaw fractures. |
|
Scientific Title of Study
|
The effect of Sequencing the condylar fracture fixation on its operative time for effective fixation amongst the patients with multifocal fractures of Mandible – A Randomized Controlled Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhadarshini Pany |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Oral & Maxillofacial Surgery,
Department of Dentistry,
C Block. Ground floor
All India Institute of Medical Sciences, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
07008660372 |
| Fax |
|
| Email |
Subhadarshinipany@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santhosh Rao |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry,
C Block. Ground floor
All India Institute of Medical Sciences, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
santhosh@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Santhosh Rao |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry,
C Block. Ground floor
All India Institute of Medical Sciences, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
santhosh@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Raipur |
| Address |
All India Institute of Medical Sciences, GE Road
Raipur |
| Type of Sponsor |
Research institution 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 |
| Dr Subhadarshini Pany |
All India Institute of Medical Sciences, Raipur |
C Block, Ground Floor, Department of Dentistry
Raipur
CHHATTISGARH |
07008660372
subhadarshinipany@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee,AIIMS,Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, (2) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ORIF with Condyle first Approach |
In multifocal fractures of the mandible Condylar fractures shall be reduced and fixed first. Duration approximately 30 minutes |
| Comparator Agent |
ORIF with Condyle last Approach |
In multifocal fractures of mandible Condylar fractures shall be reduced and fixed in the last. Duration approximately 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with multiple fracture sites in the mandible involving condyle
and any other sites like symphysis, Parasymphysis, body, and angle of the
mandible. |
|
| ExclusionCriteria |
| Details |
i. Patients below 12 years of age.
ii. Neff A classification of condylar fractures.
iii. Patients with condylar fractures involving medial cranial fossa and those
who requires neurological intervention.
iv. Only Patients who refuse to give consent.
v. Undisplaced fracture of mandible
vi. Patients unfit for Surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Operative Time for fracture reduction and fixation |
At the time of Surgery only once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Surgeons Difficulty Index as per the Likert Scale |
O Days (Operative Day) |
| Posterior Ramal Height Measurment in Ipsilateral and contralateral site |
1 Day |
| Condylar and gonial angle flaring if any |
1 Day |
| Post operative Occlusion |
7 Day |
| Facial asymmetry if any |
7 Day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No Publications answering this research question yet |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- 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 - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Subhadarshinipany@gmail.com].
- For how long will this data be available start date provided 16-01-2025 and end date provided 16-01-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Maxillofacial injuries are common in polytrauma patients, and the spectrum can be minor to life-threatening injuries. Maxillofacial injuries can be due to various causes, including road traffic accidents, assault and falls from height, industrial injuries, animal bites, sports injuries, burns, and war injuries. Mandibular fractures are more common, accounting for about 66% of total jaw fractures in a study conducted on the Indian population in 2014. Most of these fractures are solitary, but 22% and 52% involve two or more sites in the mandible. Fractures of the condylar process as the highest and contribute to 37% of total mandibular fractures, and the prevalence of Angle fracture, Para symphysis fracture, and body fractures are 27%, 17% and 15%, respectively. Amongst all mandibular fractures, multifocal fractures – the fractures occurring in multiple sites of the mandible accounts for 56%. While treating these multifocal mandibular fractures the reduction and fixation of the mandibular condylar fracture poses a difficulty to the surgeons. Establishing proper anatomical posterior ramal height and post operative occlusion is the expected end outcome of all these fractures. But due to the complexity causes by the presence of multiple fractures and ease of manipulation due to the presence of body or symphyseal fractures, surgeons differ in the opinion regarding the sequence of fixation of these fractures. If condyle fixed first the freely movable fractures aid in early reduction of the condylar segment, but on the contrary if the dentate segments are fixed earlier it aids in early occlusal reestablishment . There are few case series and opinions regarding the sequence of fixation of multifocal fractures, however a strong evidence favouring either of these is not available in the literature.Due to the paucity of the evidence suggesting the proper sequence in fixation of these multifocal fractures of the mandible, and the requirement of early and effective surgical technique to ensure faster returning to normalcy of these patients. We intend to study the effect of the sequencing of the reduction and fixation of these fractures of mandible on the operative time required for good outcome |