| CTRI Number |
CTRI/2025/08/092823 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Pre-shaped plates and Standard Plates for Treating Broken lower Jaw and Impact on Jaw Movement, Chewing Muscles. |
|
Scientific Title of Study
|
Effect of pre-twisted, pre-adapted miniplates on anatomical landmarks, TMJ analysis, masticatory muscle efficiency and occlusal stability following mandibular angle fracture management – a comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bellamkonda Divya |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Oral and Maxillofacial Surgery, Block III, Vishnu Dental College, Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
6302510017 |
| Fax |
08816250894 |
| Email |
divya.bellamkonda@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Shivaji Raju |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Oral and Maxillofacial Surgery, Block III, Vishnu Dental College, Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9966351997 |
| Fax |
08816250894 |
| Email |
shivajiraju.u@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr U Shivaji Raju |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Oral and Maxillofacial Surgery, Block III, Vishnu Dental College, Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9966351997 |
| Fax |
08816250894 |
| Email |
shivajiraju.u@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram, Andhra pradesh, India-534202 |
|
|
Primary Sponsor
|
| Name |
Dr Bellamkonda Divya |
| Address |
Department Of Oral and Maxillofacial Surgery, Block III, Vishnu Dental College, Vishnupur,Bhimavaram-534202 |
| 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 Bellamkonda Divya |
Vishnu Dental College |
Block III, room number 2, Department of Oral and Maxillofacial Surgery.
West Godavari
ANDHRA PRADESH |
6302510017
08816250894
divya.bellamkonda@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
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 |
| Intervention |
pre-adapted titanium miniplates |
straight 2mm, 4 hole with gap titanium miniplates will be adapted on a 3D model before surgery and this preadapted miniplate will be fixed during surgery |
| Intervention |
prebent titanium miniplates |
prebent 2mm, 4 hole with gap titanium miniplates, adapted and fixed during surgery |
| Comparator Agent |
straight titanium miniplate |
straight 2mm, 4 hole with gap titanium miniplates, adapted and fixed during surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients older than 18 years with unilateral mandibular angle fracture requiring ORIF
2. Minimal to moderately displaced angle fractures.
3. ASA class I,II
4. Patients willing to give an informed consent.
5. Patients presenting for at least 6 months follow-up |
|
| ExclusionCriteria |
| Details |
1. Infected, comminuted and severely displaced angle fracture
2. ASA class III,IV.
3. Patients suffering from pathological fracture.
4. Patients not consenting for the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TMJ function, electromyographic analysis of temporalis and masseter between conventional, pre-twisted and pre-adapted plates employing 3D model. |
1.TMJ function - preoperative, postoperative 6th month
2.electromyographic analysis of temporalis and masseter - preoperative, postoperative 1st month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| trismus between conventional, pre-twisted and pre-adapted plates employing 3D model |
trismus - postoperative 2nd day, 7th day |
| occlusal stability between conventional, pre-twisted and pre-adapted plates employing 3D model. |
occlusal stability - postoperative 4th week |
| Radiographic anatomical changes between conventional, pre-twisted and pre-adapted plates employing 3D model. |
Radiographic anatomical changes - preoperative, postoperative |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
20/08/2025 |
| 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="1"
Months="0"
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
|
This study compares three different types of metal plates used in the treatment of fractures in the lower jaw. These include conventional plates, pre twisted plates, and pre adapted plates. Before the surgery, a 3D model of the patient’s jaw is prepared to help in planning the treatment. The surgery is done to fix the broken bone using one of these plates. Patients are divided into three groups based on the type of plate used. The study aims to find out which method is better in terms of jaw joint function, muscle activity, bite correction, and overall healing. Muscle function will be checked using tests that record electrical activity. Jaw joint movement, bite alignment, mouth opening, and X ray changes will also be studied before and after the surgery. The goal is to improve the outcome and reduce complications in lower jaw fracture treatment. |