CTRI

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CTRI Number

CTRI/2018/10/016081 [Registered on: 18/10/2018] Trial Registered Prospectively

Last Modified On:

15/10/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison of treatment outcomes of lower jaw bone fracture managed using two different surgical methods.

Scientific Title of Study

"Comparison of the treatment outcomes of sub condylar fracture of mandible managed using one trapezoidal plate versus two nonparallel straight miniplates: A randomised controlled trial"

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Manoj Adhikari
Designation	Junior Resident
Affiliation	AIIMS, New Delhi, India.
Address	Center for dental eduction and research, Oral and Maxillofacial surgery department. 1st floor and 7th floor. All india institute of medical sciences.New DElhi, Ansari Nagar, India. New Delhi DELHI 110029 India
Phone	9871344182
Fax
Email	adhikarimanoj2017@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ajoy Roychoudhury
Designation	Professor, Head of Department.
Affiliation	All India Institute of Medical Sciences.
Address	Center for dental education and research, oral and maxillofacial surgery department. 1st floor. All india institute of medical sciences, New Delhi. New Delhi DELHI 110029 India
Phone	9891007749
Fax
Email	Ajoyroy@hotmail.com

Details of Contact Person
Public Query

Name	Dr Manoj Adhikari
Designation	Junior Resident
Affiliation	All India Institute of Medical Sciences.
Address	Center for dental education and research, Oral and maxillofacial surgery department. All india institute of medical sciences, Ansari nagar, New Delhi. New Delhi DELHI 110029 India
Phone	9871344182
Fax
Email	adhikarimanoj2017@gmail.com

Source of Monetary or Material Support

Ceter for dental education and research, Oral and maxillofacial surgery department, All india institute of medical sciences.

Primary Sponsor

Name	All India Institute of Medical Sciences
Address	Ansari nagar, New Delhi 110029.
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Manoj Adhikari	All India Institute of Medical Sciences.	Oral and maxillofacial surgery Department, 1st floor and 7th floor, CDER, AIIMS. New Delhi DELHI	9871344182 adhikarimanoj2017@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE (AIIMS DELHI)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	, (1) ICD-10 Condition: T799\|\|Unspecified early complication oftrauma,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	between two plating techniques A.two non parallel miniplates B.one trapezoidal plate	comparison of time required for fixation of subcondyle fracture by two different plating techniques intraoperatively.
Intervention	comparison of complications of subcondyle fracture managed using two different plating techniques, postoperatively.	comparison of postoperative complications, loss of reduction, plate fracture, infection, parotid fistula.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	All patients with unilateral or bilateral subcondylar fractures indicated for open reduction and internal fixation , patients age >18 years, will be included in the study group.

ExclusionCriteria

Details

patient refusing consent, pregnant ladies, paediatric patients, age <18 years, condylar head fracture, patient who cannot come for follow up, medically compromised patients will not be included in the study group.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To compare the time taken after reduction of fracture in plate fixation for one trapezoidal plate and two non parallel straight miniplates.	Intraoperatively, time starts after reduction of fracture fragments till the completion plate fixation with screws.

Secondary Outcome

Outcome	TimePoints
To compare the loss of reduction, and complications, using one trapezoidal plate versus two nonparallel straight miniplates.	6 months

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
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)

31/10/2018

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

None yet.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

For treatment of subcondylar fracture traditionally two non parallel straight miniplates are used, one trapezoidal plate is a new technique of fixation of fractured condyle. it is claimed that trapezoidal plate is better than two nonparallel miniplates in in-vitro study. in order to identify which technique is better for fixation of condylar fracture this study is being done. it includes time taken for the procedure intraoperatively, their complications, and loss of reduction.