| CTRI Number |
CTRI/2021/01/030845 [Registered on: 29/01/2021] Trial Registered Prospectively |
| Last Modified On: |
21/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of Customized Polyetheretherketone (Peek) Plate versus 3D Delta Titanium Plate for the Internal Fixation of Mandibular Subcondylar Fractures - A Clinical Study |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of CAD-CAM Assisted Patient Specific Polyetheretherketone (Peek) Plate with 3D Delta Titanium Plate for the Fixation of Mandibular Subcondylar Fractures - A Prospective Randomized Controlled Trial |
| Trial Acronym |
Polyetheretherketone (PEEK) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Wankhade |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences Deemed to be University |
| Address |
Department of Oral and Maxillofacial Surgery
Sharad Pawar Dental College and Hospital
Sawangi Meghe
Wardha
Department of Oral and Maxillofacial Surgery
Sharad Pawar Dental College and Hospital
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960180720 |
| Fax |
|
| Email |
abhishek.wankhade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niin Bhola |
| Designation |
Professor & Head |
| Affiliation |
Datta Meghe Institute of Medical Sciences Deemed to be University |
| Address |
Department of Oral and Maxillofacial Surgery
Sharad Pawar Dental College and Hospital
Sawangi Meghe
Wardha
Department of Oral and Maxillofacial Surgery
Sharad Pawar Dental College and Hospital
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970070607 |
| Fax |
|
| Email |
drnitinbhola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Wankhade |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences Deemed to be University |
| Address |
Department of Oral and Maxillofacial Surgery
Sharad Pawar Dental College and Hospital
Sawangi Meghe
Wardha
Department of Oral and Maxillofacial Surgery
Sharad Pawar Dental College and Hospital
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960180720 |
| Fax |
|
| Email |
abhishek.wankhade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery
Sharad Pawar Dental College and Hospital at
Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Medical Sciences,
Sawangi Meghe,
Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences Deemed to be University |
| Address |
Sawangi Meghe Wardha
442001 |
| Type of Sponsor |
Private medical 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 Abhishek Wankhade |
Sharad Pawar Dental College and Hospital, Sawangi Meghe, Wardha |
Department of Oral and Maaxillofacial Surgery, Sharad Pawar Dental College and Hospital, Sawangi Meghe, Wardha
pin - 442001
Wardha
MAHARASHTRA |
9960180720
abhishek.wankhade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M96||Intraoperative and postproceduralcomplications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD-CAM assisted customized patient specific PEEK plates for fractured mandibular condyle |
The CAD-CAM assisted Customized PEEK plate will be used for the open reduction and internal fixation of mandibular subcondylar fractures |
| Comparator Agent |
Conventionally available preformed 3D Delta Titanium plats for mandibular condyle |
Conventionall available preformed 3D Delta Titanium plats will be used to for the open reduction and internal fixation of mandibular subcondylar fractures |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Cases of unilateral mandibular subcondylar fractures (mostly associated with symphysis / parasymphysis fracture).
Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
Systemically healthy patients with ASA I/II grades.
Patients with good general condition allowing major surgical procedure under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients with trifocal fractures in mandible will be excluded from the study.
Patients with old fractures as they might affect accuracy of reduction of the fractured segments.
Patient with comminuted fracture in condylar region
Patients with bone loss or soft tissue loss at fracture site
Endocrinopathies affecting calcium metabolism, chronic smokers, post menopausal women.
Patients with mixed dentition and edentulous lower arch
Evidence of infections at fracture site (diagnosed clinically, not with culture)
Epileptic patients
Medically compromised patients not fit for surgery.
Patient not willing for surgical treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The CAD-CAM assisted customized PEEK plate may be more effective in achieving the goals of fixation of mandibular subcondylar fractures as compared to the 3D Delta Titanium plates |
Postoperatively 1st Week, 4th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The CAD-CAM assisted customised PEEK plate may be more effective in achieving the goals of fixation of mandibular subcondylar fractures as compared to the 3D Delta Titanium plates. |
Postoperatively 1st week, 4th week and 12th week |
|
|
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)
|
01/02/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
The
current study is
designed to generate the evidence for the use of CAD-CAM assisted customized
PEEK plate for accurate reduction and fixation of mandibular subcondylar
fractures with minimal post-operative complications as compared to conventional
3D Delta Titanium plates |