| CTRI Number |
CTRI/2019/08/020526 [Registered on: 02/08/2019] Trial Registered Prospectively |
| Last Modified On: |
01/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
comparison between 3D plates vs miniplate fixation in low condylar fractures |
|
Scientific Title of Study
|
Efficacy of fixation of low condylar fractures (condylar neck/head fracture) using trapezoidal 3D
plate vs. conventional miniplate osteosynthesis – a
prospective observational study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASMITA UNADKAT |
| Designation |
Department of oral and maxillofacial surgery. Post graduate. |
| Affiliation |
Manipal College of Dental Sciences ,Manipal |
| Address |
Department of oral and maxillofacial surgery,
Room no. 4,
Manipal College of Dental Sciences,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9714714798 |
| Fax |
|
| Email |
asmitaunadkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Nayak |
| Designation |
Associate professor |
| Affiliation |
Manipal college of dental sciences |
| Address |
Room no 4
Department of oral and maxillofacial surgery
Manipal college of dental sciences
Udupi
KARNATAKA
576104
India |
| Phone |
9845308590 |
| Fax |
|
| Email |
sunilmaxfac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Unadkat |
| Designation |
Post graduate. |
| Affiliation |
Manipal college of dental sciences |
| Address |
Department of oral and maxillofacial surgery.
Manipal college of dental sciences
Manipal
502
Mandavi paradise
End point road
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9714714798 |
| Fax |
|
| Email |
asmitaunadkat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Asmita Unadkat
Department of oral and maxillofacial surgery.
Manipal college of dental sciences.
Manipal |
|
|
Primary Sponsor
|
| Name |
Asmita Unadkat |
| Address |
Room No 4 ,Department of Oral and Maxillofacial Surgery ,MCODS,Manipal,KARNTAKA 576104 |
| Type of Sponsor |
Other [My self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Asmita Unadkat |
Room No 4 ,Department of Oral and Maxillofacial Surgery ,MCODS,Manipal,KARNTAKA 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asmita |
Manipal college of dental sciences |
Room No 4 ,Department of Oral and Maxillofacial Surgery ,MCODS,Manipal,KARNTAKA 576104
Udupi
KARNATAKA |
9714714798
asmitaunadkat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and hospital IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with low condylar (condylar base/neck) fracture of mandible |
|
| ExclusionCriteria |
| Details |
Condylar head fracture (intracapsular)
Paediatric patients
Patients unfit for surgery
Patient who could not be followed up post operatively for minimum 6 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To conclude efficacy of fixation between Trepezoidal plate and miniplate in mandibular low-
Condylar (condylar base/neck) fractures. |
3rd post-operative day
After 1 week
After 6 weeks
After 3 months
After 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To conclude efficacy of fixation between Trepezoidal plate and miniplate in mandibular low-
Condylar (condylar base/neck) fractures. |
3rd post-operative day
After 1 week
After 6 weeks
After 3 months
After 6 months
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To assess and compare the efficacy and stability of Trapezoidal 3D plates vs. double mini plate osteosynthesis for fixation of mandibular condylar neck/head fractures. To evaluate criteria perioperatively I) pre-operative evaluation Occlusion Ii) intra-operative evaluation Time/duration of surgery Iii) post-operative evaluation Clinical evaluation- Pain Occlusion Infection Radiographic evaluation- Hardware failure Malunion/non-union |