| CTRI Number |
CTRI/2022/08/044687 [Registered on: 05/08/2022] Trial Registered Prospectively |
| Last Modified On: |
05/08/2022 |
| 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
|
Efficacy of twinfork shaped plates versus single miniplates in the management of lower jaw fractures |
|
Scientific Title of Study
|
Twinfork miniplate versus Single miniplate for the fixation of fractures at parasymphysis - body Region of mandible - A Comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRUJANA TANGELLA |
| Designation |
POST GRADUATE |
| Affiliation |
Kaloji Narayana Rao University of Health Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Room no 2, MNR Dental College and Hospital, MNR Nagar, Fasalwadi, Narsapur road, Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
08978912802 |
| Fax |
|
| Email |
srujana1727@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K RAMESH |
| Designation |
HOD and Professor |
| Affiliation |
Kaloji Narayana Rao University of Health Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Room no 2, MNR Dental College and Hospital, MNR Nagar, Fasalwadi, Narsapur road, Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
9502099668 |
| Fax |
|
| Email |
rameshmaxillofacialsurgeon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRUJANA TANGELLA |
| Designation |
POST GRADUATE |
| Affiliation |
Kaloji Narayana Rao University of Health Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Room no 2, MNR Dental College and Hospital, MNR Nagar, Fasalwadi, Narsapur road, Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
08978912802 |
| Fax |
|
| Email |
srujana1727@gmail.com |
|
|
Source of Monetary or Material Support
|
| MNR Dental college and hospital,Room no 2, Department of Oral and Maxillofacial Surgery,
MNR Nagar,
Fasalwadi,
Narsapur road, Sangareddy, Telangana, 502294 |
|
|
Primary Sponsor
|
| Name |
MNR Dental College and Hospital |
| Address |
MNR Nagar, Fasalwadi, Sangareddy, Telangana, 502294 |
| Type of Sponsor |
Other [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 |
| Srujana Tangella |
MNR Dental college and hospital |
room no. 2, Department of Oral and Maxillofacial Surgery,
mnr nagar, Fasalwadi, Sangareddy, Telangana 502294
Medak
TELANGANA |
8978912802
srujana1727@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MNR INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: V294||Motorcycle driver injured in collision with other and unspecified motor vehicles in traffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Single miniplate |
Single miniplates used for the fixation of fractures in the parasymphysis - body transition zone of the mandible. |
| Intervention |
Twinfork miniplate |
Twinfork miniplates used for the fixation of fractures in the parasymphysis - body transition zone of the mandible.
The duration of the procedure would be approximately 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All fractures of mandibular parasymphysis-body(transition zone).
2. Patients in the age of 18- 65 yrs.
|
|
| ExclusionCriteria |
| Details |
1. Patients with fracture comminution.
2. Patients with frank infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occlusion between the maxillary and mandibular teeth |
1 month after surgery, 3 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bite force measured by placing a bite force instrument between maxillary and mandibular first molars |
1 month after surgery, 3 months after surgery |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/08/2022 |
| 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="0"
Months="5"
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
|
Parasymphysis/body fractures of the mandible have reported
to occur with a frequency of 9% to 57%. Therefore, a
surgeon should have an appropriate understanding of the biomechanics of
different plating systems and techniques used to fix these fractures. There is
always a dilemma for the surgeon as to whether to fix
these mandibular segments with one or two miniplates, and the presence of
mental neurovascular bundle makes it more challenging. The purpose of
this study is to evaluate the biomechanical
behavior of a newly designed twin-fork shaped miniplate for the fixation of
fractures involving the parasymphysis-body transition region and to compare the
same with the conventional single miniplates. This randomised
controlled trial will be done on 30 patients requiring fixation of fractures in the parasymphysis- body transition zone of the mandible. In group A, fixation is done using twinfork miniplates and in group B, single miniplates are used for fixation.
|