| CTRI Number |
CTRI/2024/12/078710 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of lower jaw fractures. |
|
Scientific Title of Study
|
Evaluation of the Efficacy of single modified Y-shaped Titanium miniplate in the management of Mandibular Angle fractures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gudipalli Sudhakar |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Department of Oral and Maxillofacial Surgery
Government Dental College
Vijayawada
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
8008372713 |
| Fax |
|
| Email |
gsletterbox@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr . K .SUREKHA |
| Designation |
HOD & PROFESSOR |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Department of Oral and Maxillofacial Surgery
Government Dental College
Vijayawada
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
9949852027 |
| Fax |
|
| Email |
drsurekhagontu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghanta Chaitanya |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital Vijayawada |
| Address |
Department of Oral and Maxillofacial Surgery Government Dental College and Hospital Vijayawada
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
9985806288 |
| Fax |
|
| Email |
dr.chaitanyaomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Vijayawada
Andhra Pradesh
India-520004 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Sudhakar |
Government Dental College and Hospital Vijayawada |
Room no 3 Department of Oral and Maxillofacial Surgery PG Division
Krishna
ANDHRA PRADESH |
8008372713
gsletterbox@gmail.com |
| Dr Mohan Kumar S |
Government Dental College and Hospital Vijayawada |
Room no 3
Department of Oral and Maxillofacial Surgery
PG Division
Krishna
ANDHRA PRADESH |
9108363400
mohankumarselva1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GDCH VIJAYAWADA |
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 |
N/A |
N/A |
| Intervention |
Reduction and fixation of mandibular fractures |
open reduction and internal fixation with single modified Y-shaped Titanium miniplate in mandibular angle fractures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients aged more than 18 years
2.patients with mandibular angular fractures |
|
| ExclusionCriteria |
| Details |
patients who are having high risk systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intra operative time
Stability of fixation
Biting Efficiency |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain in the Surgical site
Mouth opening
Healing of Operated area |
base line , 1 week ,4 weeks,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
08/01/2025 |
| 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="9"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 (Others) - STATISTICS ONLY
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response (Others) - RESEARCHERS WORKING IN THE SAME FIELD
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - PLEASE MESSAGE TO MY E-MAIL
- For how long will this data be available start date provided 06-08-2023 and end date provided 06-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO
|
|
Brief Summary
|
The present study is undertaken to evaluate the clinical outcomes associated with the use of modified Y shaped titanium miniplate placed at the angle of mandible. Modified Y shaped titanium plate offers advantage because of its unique design which is designed by us. As it reinforces the stability of the mandibular fractures by modification of straight 4 hole titanium mini plate with angulated 2 hole accessory arm. |