| CTRI Number |
CTRI/2025/03/082842 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A lab and clinical Testing of new plating system for jaw bone fracture |
|
Scientific Title of Study
|
EFFICACY OF NOVEL UNI-PLATING SYSTEM FOR SYMPHYSIS FRACTURE BASED ON CHAMPY’S LINE OF OSTEOSYNTHESIS : AN IN VITRO AND IN VIVO STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chinta Chetana Hota |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Siddartha Dental College |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College, Agalakote, B.H. Road, Tumkur - 572 107, Karnataka - India
Tumkur
KARNATAKA
572107
India |
| Phone |
8249231710 |
| Fax |
|
| Email |
hotachetna@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar R |
| Designation |
Head of the department |
| Affiliation |
Sri Siddhartha Dental College |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College, Agalakote, B.H. Road, Tumkur - 572 107, Karnataka - India
Tumkur
KARNATAKA
572107
India |
| Phone |
9845417365 |
| Fax |
|
| Email |
mahu017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar R |
| Designation |
Head of the department |
| Affiliation |
Sri Siddhartha Dental College |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College, Agalakote, B.H. Road, Tumkur - 572 107, Karnataka - India
Tumkur
KARNATAKA
572107
India |
| Phone |
9845417365 |
| Fax |
|
| Email |
mahu017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Siddhartha Dental College, Agalakote, B.H. Road, Tumkur - 572 107, Karnataka - India |
|
|
Primary Sponsor
|
| Name |
Dr Chinta Chetana Hota |
| Address |
Room no.2, department of oral and maxillofacial surgery, Sri Siddhartha Dental College, Agalakote, B.H. Road, Tumkur - 572 107, Karnataka - India |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 Chinta Chetana Hota |
Sri Siddhartha Dental College and hospital |
Room no.2, department of oral and maxillofacial surgery, Agalakote,
Tumkur
KARNATAKA |
8249231710
hotachetna@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri siddhartha 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: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional plating system for mandible symphysis fracture |
conventional plate is 4 hole with gap 2.5mm titanium plate |
| Intervention |
uni-plating system for mandibular symphysis fracture |
uni-plate is 6 hole 2.0mm titanium plate based on champys line of osteosynthesis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Fractures in the symphysis region of the mandible, which may be simple or compound or comminuted fractures
Fractures suitable for treatment through an intra-oral approach and extra oral approach for pre-existing laceration.
Individuals approved for surgery by a physician according to ASA classification.
Patients willing to actively participate in clinical and radiological follow-up throughout the study period.
|
|
| ExclusionCriteria |
| Details |
Patients unwilling for receiving treatment.
Patients presenting with cysts and tumors.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative stability of the plating system. |
24 hours, 7 days, 3 months and 6 months post-operative visits. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
achievement of occlusal stability
|
24 hours, 7 days, 3 months and 6 months post-operative visits. |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
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 1 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
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
|
This study aims to evaluate the efficacy of a novel uni-plating system for the fixation of symphysis fractures following Champy’s line of osteosynthesis principles. The research is designed as a non-comparative study conducted in two phases. In Vitro Phase – Biomechanical testing of the novel uni-plating system on synthetic bone models to assess stability and load-bearing capacity. In Vivo Phase – Clinical application of the novel plating system in patients with symphysis fractures to evaluate functional outcomes, stability, and postoperative complications over a defined follow-up period. The study aims to establish the efficacy, feasibility, and potential advantages of this novel plating system in fracture management. Clinical parameters such as fracture healing, occlusal stability, infection rates, and patient-reported outcomes will be assessed. |