| CTRI Number |
CTRI/2019/01/017116 [Registered on: 17/01/2019] Trial Registered Prospectively |
| Last Modified On: |
11/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different types of treatment in Mandibular condyle fracture |
|
Scientific Title of Study
|
Mandible condylar fracture treatment: Y-shaped plate Vs
Trapezoidal Condylar Plate: A Randomized Controlled 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 Kirti Chaudhry Dutt |
| Designation |
Associate Professor |
| Affiliation |
AIIMS JODHPUR RAJASTHAN |
| Address |
Room NO 214,
Department of dentistry, 2-A Block OPD Block
All India Institution of Medical Sciences JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003993889 |
| Fax |
|
| Email |
chaudhry_kirti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS JODHPUR RAJASTHAN |
| Address |
Room NO 214,
Department of dentistry, 2-A Block OPD Block
All India Institution of Medical Sciences JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9041892890 |
| Fax |
|
| Email |
kumar.shailendra0904@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTION OF MEDICAL SCIENCES, JODHPUR |
| Address |
Room NO 214,
Department of dentistry, 2-A Block OPD Block
All India Institution of Medical Sciences JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9041898290 |
| Fax |
|
| Email |
kumar.shailendra0904@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dentistry, All India Institution of Medical Sciences, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Department of Dentistry All India Institution of Medical Sciences Jodhpur |
| Address |
Department of Dentistry, All India Institution of Medical Sciences Jodhpur |
| 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 Kirti Chaudhry |
All India Institution of Medical Sciences Jodhpur |
Room No 214, Department of Dentistry, 2-A Block OPD Block
Jodhpur
RAJASTHAN |
8003993889
chaudhry_kirti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institution of Medical Sciences Jodhpur |
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 |
TRAPEZOIDAL CONDYLAR PLATE |
TRAPEZOIDAL CONDYLAR PLATE TO BE USED FOR MANDIBLE CONDYLAR FRACTURE POSTOPERATIVE TREATMENT OUTCOMES (CLINICAL AND RADIOGRAPHICAL) WILL BE ASSESSED ON DAY 1 7 30 90 180 |
| Intervention |
Y-shaped plate |
Y-shaped plate to be used for Mandible condylar fracture postoperative treatment outcomes (Clinical and Radiographical) will be assessed on day 1 7 30 90 180 |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group between 16-65 years
2. Patient with unilateral or bilateral condylar fractures.
3. Good physical and mental condition (ASA I , II )
4. Absence of infection or trauma prior to the surgery. |
|
| ExclusionCriteria |
| Details |
1. Age <16 years and >65 years.
2. Patients/with life threatening cardio-respiratory co-morbidities increasing risk of complication during GA
like previous MI/under treatment for CAD,COPD patients, severe hepatic and renal impairment, patients
with head injury (condition that increased amount of pressure in brain).
3. Patient diagnosed with pan-facial fractures.
4. Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anatomical Reduction of fracture at day 180 postoperative |
Anatomical Reduction of fracture at day 180 postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction under direct vision
Time of plating (time from final reduction to last screw tightened)
Fracture reduction assessment
Occlusion
Orthopantomogram
Townes View
Maximum mouth opening
Maximum lateral excursive movement
Electromyography
Temporomandibular joint Dysfunction (TMD)
Post operative Pain assessed through VAS score
Swelling
Plate Infection
Plate fracture & Screw loosening
Sialocele/Parotid Fistula
Facial Nerve Injury. |
DAY 1 7 30 90 180 |
|
|
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)
|
21/01/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
all the patients with mandible condylar fracture who will be fulfilling the inclusion and exclusion criteria and giving an informed written consent for the procedure/study would be included. In all included patients, ‘fracture deviation’ and ‘pain score’ will be assessed by Computed Tomography (CT) scan and using VAS preoperatively respectively. All the patients with mandible condylar fracture will be admitted and preoperative occlusion will be assessed and detailed proforma will be filled. All the included patients will be allocated to one of the 2 groups using a table of random numbers. Group A (Control): To be treated by using Trapezoidal condylar plate (TCP). Group B (Case): To be treated by using Y-shaped plate. Surgery would be done by approaching the fractured site through indicated surgical approach. Open reduction and internal fixation(ORIF) will be proformed with intraoperative photographic documentation using Trapezoidal Condylar Plate(TCP) and Y-shaped plate. All the patients of both the groups (cases as well as control) will be assessed by a single observer through a well designed proforma. |