| CTRI Number |
CTRI/2014/10/005110 [Registered on: 15/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
23/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Checking of jaw fracture fixing with different shapes of plates for healing of bone. |
|
Scientific Title of Study
|
An evaluation of 3-dimensional titanium mini plate over conventional titanium mini plate fixation in treatment of mandibular fracture - A comparative and clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1156-2943 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagendra Kumar Atluri |
| Designation |
post graduate tranee |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
Department of oral and Maxillofacial surgery, SIBAR institute of Dental sciences, takkelapadu, Guntur
Department of oral and Maxillofacial surgery,SIBAR institute of Dental sciences Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9652226444 |
| Fax |
08632292139 |
| Email |
atlurinagendrakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sridhar |
| Designation |
Professor |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
Department of oral and Maxillofacial surgery,SIBAR institute of Dental sciences Guntur
Department of oral and Maxillofacial surgery,SIBAR institute of Dental sciences Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9848276826 |
| Fax |
08632292139 |
| Email |
meka.sridhar@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Asst Prof |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
Department of oral and Maxillofacial surgery,SIBAR institute of Dental sciences Guntur
Department of oral and Maxillofacial surgery,SIBAR institute of Dental sciences Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9912400988 |
| Fax |
08632292139 |
| Email |
drvivekanandsk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SIBAR institute of Dental sciences Guntur |
| Address |
Department of oral and Maxillofacial surgery,SIBAR institute of Dental sciences Guntur |
| Type of Sponsor |
Other [SIBAR institute of Dental sciences GunturDental college and Hospital ] |
|
|
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 Nagendra Kumar |
Department of Oral and Maxillofacial surgery |
SIBAR institute of Dental sciences, Guntur. Andhra Pradesh. India
Guntur
ANDHRA PRADESH |
9652226444
atlurinagendrakumar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical conmitte of SIBAR institute of Dental sciences, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Isolated mandibular fractures involving symphysis, or parasympysis, or body, or angle , (1) ICD-10 Condition: M843||Stress fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3-D mini plates |
Commercially available 3-D mini plates for osteosynthesis |
| Intervention |
Champys miniplate |
Commercially available mini plates for osteosynthesis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
Patients with isolated fracture of mandible involving symphysis, or PA r a symphysis, body or angle, patients with ASA-I category , Adequate patients complaince, |
|
| ExclusionCriteria |
| Details |
Immunocompremised patients, patient underwent radiotherapy for head neck regions, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of fracture |
1,4,8,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Function, esthetics |
1 week, 1,2,3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/04/2013 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Yet to complete the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is blind parallel group trail comparing the saftey and efficacy of 3-dimensional titanium mini plate vs champhys titanium mini plates in the management of isolated mandibular fracture. The primary outcome measures will be healing of fracture. The secondary out come measures will be function and esthetics. In due time corelation of age, sex, pain, swelling with biting force will be measured to know the effects on early function. |