| CTRI Number |
CTRI/2022/02/040238 [Registered on: 11/02/2022] Trial Registered Prospectively |
| Last Modified On: |
02/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MINI PLATE DESIGN] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
the evaluation of trinity plate in fixation of mandibualar jaw fractures |
|
Scientific Title of Study
|
the evaluation of trinity plate in the reduction and fixation of symphysis and parasymphysis fractures of mandible: a prospective clinical 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 B K Manohar |
| Designation |
post graduate |
| Affiliation |
narayana dental college |
| Address |
Dept. of oral and maxillofacial surgery,
narayana dental college and hospital,
chinthareddypalem, nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8500221764 |
| Fax |
|
| Email |
dr.manumanohar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR D SATHYA KUMAR |
| Designation |
Professor |
| Affiliation |
narayana dental college |
| Address |
Dept. of oral and maxillofacial surgery,
narayana dental college and hospital,
chinthareddypalem, nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441127171 |
| Fax |
|
| Email |
satyadevireddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR B K MANOHAR |
| Designation |
post graduate |
| Affiliation |
narayana dental college |
| Address |
Dept. of oral and maxillofacial surgery,
narayana dental college and hospital,
chinthareddypalem, nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8500221764 |
| Fax |
|
| Email |
dr.manumanohar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and hospital
Nellore |
|
|
Primary Sponsor
|
| Name |
B K MANOHAR |
| Address |
DEPT OF ORAL AND MAXILLOFACIAL SURGERY
NARAYANA DENTAL COLLEGE AND HOSPITAL NELLORE |
| 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 B K MANOHAR |
DEPT OF ORAL AND MAXILLOFACIAL SURGERY |
DEPT OF ORAL AND MAXILLOFACIAL SURGERY, NARAYANA DENTAL COLLEGE AND HOSPITAL, NELLORE
Nellore
ANDHRA PRADESH |
8500221764
dr.manumanohar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE |
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 |
NIL |
NIL |
| Intervention |
Trinity plate |
2 x 6 holed modified plate with upper 2 holes connected by bar and lower 4 holes with gap and upper and lower connected by vertical bar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
NON COMMINUTED NON INFECTED MANDIBULAR SYMPHYSIS AND PARA SYMPHYSIS FRACTURE WITH ANY OTHER CONCOMITANT FRACTURE
SINGLE NON COMMINUTED FRACTURE OF THE MANDIBULAR SYMPHYSIS AND / OR PARASYMPHYSIS REQUIRING OPEN REDUCTION AND INTERNAL FIXATION |
|
| ExclusionCriteria |
| Details |
PATIENT NOT FIT FOR GENERAL ANESTHESIA OR LOCAL ANESTHESIA
PATIENT WITH SYSTAMIC DISEASES
PATIENT WITH ASSOCIATED MANDIBUALR BONE PATHOLOGY
PATIENT WHO DONT GIVE CONSENT FOR THE STUDY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
STABILITY OF PLATE
OCCLUSAL DISCREPANCY
POST OPERATIVE MOUTH OPENING
POST OPERATIVE COMPLICATIONS |
1week, 1month, 3months, 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
INTERFRAGMENTARY GAP
INFERIOR BORDER CONTINUITY |
1week, 1month, 3months, 6months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Mandibular fractures represent the second most common facial fractures, preceded by nasal bone fractures. Symphysis/ parasymphysis fractures comprise15.6 to 29.3%of mandibular fractures. 2. Various treatment modalities in managementof maxillofacial trauma range from conservative procedureslike maxillo-mandibular fixation,splints to surgical options such as circum-mandibular wiring and semi-rigid fixationwith trans-osseous wiring to rigid fixationwith compression platesand recently semi-rigid fixation with mini plates. 3. Fixationby conventional stainless steelmini plate carrieshigh morbidity and infection rates.Whereas theprobablelimitationof 3D platesmay be excessive implantmaterial. 4. Hence the new design of mini plate has been developed in an attempt to overcome limitations of previous fixation techniques and to acquire better retention as well as stability. |