| CTRI Number |
CTRI/2024/12/078744 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of 3D Miniplates in Anterior Mandibular Fracture Fixation |
|
Scientific Title of Study
|
Efficacy OF 3D Miniplates for Internal Fixation of Anterior Mandibular Fractures |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parijat Sinha |
| Designation |
Post Graduate Student |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room no. 3 Department of Oral and Maxillofacial surgery, Sree Balaji Dental College and Hospital, Velachery Main road, Narayanapuram, Pallikaranai, Chennai
Chennai
TAMIL NADU
600100
India |
| Phone |
9304502262 |
| Fax |
|
| Email |
parijatsinha04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Ebenezer |
| Designation |
Professor and Head of Department |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room no. 3 Department of Oral and Maxillofacial surgery, Sree Balaji Dental College and Hospital, Velachery Main road, Narayanapuram, Pallikaranai, Chennai
Chennai
TAMIL NADU
600100
India |
| Phone |
9840136328 |
| Fax |
|
| Email |
drvijayomfs@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Ebenezer |
| Designation |
Professor and Head of Department |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room no. 3 Department of Oral and Maxillofacial surgery, Sree Balaji Dental College and Hospital, Velachery Main road, Narayanapuram, Pallikaranai, Chennai
Chennai
TAMIL NADU
600100
India |
| Phone |
9840136328 |
| Fax |
|
| Email |
drvijayomfs@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Dental College and hospital, Velachery main road, Narayanpuram, Pallikaranai, Chennai- 600100 |
|
|
Primary Sponsor
|
| Name |
Parijat Sinha |
| Address |
Room no. 3 Department of Oral and Maxillofacial Surgery, Sree Balaji Dental College and Hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai 600100 |
| Type of Sponsor |
Other [Self] |
|
|
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 Parijat Sinha |
Sree Balaji Dental College and Hospital |
Room no. 3, Department of Oral and Maxillofacial Surgery, Velachery main road, Narayanapuram, Pallikaranai, Chennai 600100
Chennai
TAMIL NADU |
9304502262
parijatsinha04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE (CLINICAL TRIAL) SREE BALAJI DENTAL COLLEGE AND HOSPITAL |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D miniplates for internal fixation of anterior mandibular fractures |
3D titanium plates will be used for reduction and fixation of fractures in the anterior mandible region including symphysis and parasymphysis |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Cases with fractures in the mandibular symphysis and parasymphysis region |
|
| ExclusionCriteria |
| Details |
Comminuted symphysis and parasymphysis fractures
Patients with pre-existing infection at fracture site
Completely edentulous patients
Immuno-Compromised patients
Patients with other systemic conditions contraindicated for surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced operative time
Minimal implant material |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduced edema
Stability in 3 dimensions
|
At baseline, 1 week post op, 2 week post op |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
11/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The hypothesis suggests that the use of 3D miniplates for symphysis and para-symphysis fracture fixation provides advantages in terms of reduced operative time, and minimal implant material usage compared to traditional fixation methods.
The primary purpose of the study is to evaluate the Decrease in the incidence of malocclusion and hardware failure. Simultaneous stabilization of the tension and compression zones. Reduced operating time, due to less time required for adaptation of 3D plate Reduced post-operative edema due to less soft tissue dissection. Decrease in the incidence of paresthesia Moreover, 3D plates provide more stability in 3 dimensions against torsion forces, vertical displacement, bending, and shearing forces |