| CTRI Number |
CTRI/2025/07/090387 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to evaluate effectiveness of double-y shaped miniplate and 3-dimensional miniplate versus conventional miniplate in the lower jaw bone fractures.
|
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Scientific Title of Study
|
A comparative study to evaluate efficacy of double-y shaped miniplate and 3-d miniplate versus conventional miniplate in interforaminal mandibular fractures – A randomized controlled trial. |
| 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 Suraj Sathyendra |
| Designation |
Post Graduate Student |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of oral and maxillofacial surgery, Rajarajeswari dental college and hospital, No. 14, Ramohalli cross, Kumbalgodu, Mysore Road, Bengaluru 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
8310023764 |
| Fax |
|
| Email |
sathyendra.suraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamatha N S |
| Designation |
Professor and HOD |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Rajarajeswari Dental College and Hospital, No.14, Ramohalli cross, Kumbalgodu, Mysore Road, Bangalore 560074
Bangalore Rural
KARNATAKA
56074
India |
| Phone |
9880194412 |
| Fax |
|
| Email |
mamathans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamatha N S |
| Designation |
Professor and HOD |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Rajarajeswari Dental College and Hospital, No.14, Ramohalli cross, Kumbalgodu, Mysore Road, Bangalore 560074
Bangalore Rural
KARNATAKA
56074
India |
| Phone |
9880194412 |
| Fax |
|
| Email |
mamathans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital, No. 14, Ramohalli cross, Kumbalgodu, Mysore Road, Bengaluru 560078 |
|
|
Primary Sponsor
|
| Name |
Dr. Suraj Sathyendra |
| Address |
Rajarajeswari Dental College and Hospital.
No. 14, Ramohalli Cross, Kumbalgodu, Mysore Road, Bangalore 560074 |
| 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 Suraj Sathyendra |
Rajarajeswari dental college and hospital |
Room no. 3, Department of Oral and Maxillofacial Surgery, Rajarajeswari Dental college and hospital, No. 14, Ramohalli cross, Kumbalgodu, Mysore Road, Bangalore , 560074
Bangalore Rural
KARNATAKA |
8310023764
sathyendra.suraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Dental College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3- Dimensional(3-D) Miniplate |
3-D miniplates are the the type of miniplates which have an interconnecting rod in between the conventional miniplates which provide the 3 dimensional stability. This 3- dimensional miniplate will be used for fixation in interforaminal mandibular fractures. |
| Comparator Agent |
Conventional 4 hole with gap double miniplates |
The conventional system of miniplates include two 4 hole with gap miniplates and are fixed according to Champy’s principles. This conventional 4 hole with gap double miniplates Will be used for fixation in interforaminal mandibular fractures. |
| Intervention |
Double - Y shaped miniplate |
Double-y shaped miniplates are the newer type of miniplates which have y shaped ends on either sides of the plate. This double -y shaped miniplate will be used for fixation in interforaminal mandibular fractures. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient in the age group 18 to 65 years.
2. Patient reporting with interforaminal mandibular fractures indicated for open reduction
and internal fixation. |
|
| ExclusionCriteria |
| Details |
1. Patient with severely comminuted fracture.
2. Patient with infected mandibular interforaminal fracture.
3. Patient with systemic conditions affecting the bones and teeth.
4. Patient with psychiatric illness. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To determine the best available plating option among the most commonly used systems of plating in the interforaminal region. |
Post op day 1, post op day 7 and 1 month post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine which plating system takes the least operative time. |
Intraoperatively |
| To determine the plating system that best controls lingual splaying postoperatively. |
Post op day 1, post op day 7 and 1 month post operatively |
| To determine the plating system that provides best post-operative results. |
Post op day 1, post op day 7 and 1 month post operatively. |
| To establish a reference for the surgeon to determine the plating system based on the case. |
Post op day 1, post op day 7 and 1 month post operatively. |
|
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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)
|
21/07/2025 |
| 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="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
|
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Brief Summary
|
Despite the promising Bio mechanical advantages of three-dimensional painting system and double Y plating system, their remains paucity in the clinical data comparing these novel designs with conventional mini plates in the management of Mandibular fractures, while several studies have explored the bio mechanical properties and in vitro performance of these systems. Robust clinical trials that comprehensively assess outcomes such as fracture, stability, occlusal restoration, post-operative pain, infection rates, and recovery of bite force are limited. Such comparative analysis are essential as the optimal fixation technique not only influences the immediate surgical outcome but also affects long-term functional recovery and patient satisfaction along with providing a reference to the surgeon to determine the best plating system based on the type of fracture. The presence study is designed to address this critical gap and literature by assessing the best fixation technique Among double -y And three dimensional mini plates versus conventional methods for the most common mandibular fractures. Study design: in vivo study. Study population: study will be performed on patients reporting to the institution for seeking treatment for interforaminal mandibular fractures. The patients will be prospectively randomised into three groups as follows. Group 1-ORIF with double Y shaped mini plate Group 2-ORIF with three dimensional mini plate Group 3-ORIF with conventional double mini plates.
Evaluation parameters: Pre-operatively, Clinical parameters- Segmental mobility, occlusion, teeth in the line of fracture Radiological parameters- Displacement of fracture
Intra operatively, Clinical parameters- Plate handling time, ease of plate, adaptation and positioning of plates, adequacy of fracture reduction.
Post operatively, Clinical parameters- Fracture stability, occlusion discrepancy, neuro sensory deficit, severity of pain, condition of teeth in the line of fracture. Radiological parameters- Adequacy of reduction, lingual splaying. Other outcomes determined- Wound dehiscence, fracture of plate, screws loosening, Infections, non union or malunion.
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