CTRI Number |
CTRI/2022/07/043920 [Registered on: 12/07/2022] Trial Registered Prospectively |
Last Modified On: |
10/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical trial comparing one load bearing fixation and one load sharing fixation versus two load sharing fixation in double mandibular fracture |
Scientific Title of Study
|
‘‘Comparative study to evaluate the occurrence of nonunion/malunion in the double mandibular fracture patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation – Randomized 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 |
KISHORE M S |
Designation |
Junior Resident (Academic) |
Affiliation |
CDER,AIIMS, new Delhi |
Address |
Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi
New Delhi DELHI 110029 India |
Phone |
9790903321 |
Fax |
|
Email |
mskishoremalaiselvam@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ongkila Bhutia |
Designation |
Professor |
Affiliation |
CDER,AIIMS, new Delhi |
Address |
Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi
New Delhi DELHI 110029 India |
Phone |
9313349564 |
Fax |
|
Email |
dr.ongkila@gmail.com |
|
Details of Contact Person Public Query
|
Name |
KISHORE M S |
Designation |
Junior Resident (Academic) |
Affiliation |
CDER,AIIMS, new Delhi |
Address |
Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi
New Delhi DELHI 110029 India |
Phone |
9790903321 |
Fax |
|
Email |
mskishoremalaiselvam@gmail.com |
|
Source of Monetary or Material Support
|
Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi |
|
Primary Sponsor
|
Name |
KISHORE M S |
Address |
Department of Oral and Maxillofacial Surgery,CDER, AIIMS, New Delhi-110029 |
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 M S Kishore |
CDER,AIIMS |
Room no 115,
Department of Oral and Maxillofacial Surgery, CDER, AIIMS, New Delhi-110029 New Delhi DELHI |
9790903321
mskishoremalaiselvam@gamil.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Load sharing fixation and load bearing fixation |
Miniplate and Reconstruction plate in double mandibular fracture patient. Patients will be reviewed after 10 weeks of placement for evaluating malunion or non union |
Comparator Agent |
two load sharing fixation |
Two miniplates in double mandibular fracture patients. Patients will be reviewed after 10 weeks of placement for evaluating malunion or nonunion |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients with double mandibular fracture |
|
ExclusionCriteria |
Details |
Edentulous patients with atrophic mandible, Patients with condyle, coronoid or ramus fracture, Patients having fracture with bone loss who need bone graft, Infected mandibular fractures, Comminuted mandibular fractures,Patients with old mandibular fractures who requires surgery for residual deformities
>8 wecks from time of trauma ).
7. Pan facial trauma/associated maxillary fracture requiring postoperative I |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Non-union |
non-union will be assessed after 10 weeks of placement |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pain and infection |
after 10 weeks of placement of the plates |
|
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
|
N/A |
Date of First Enrollment (India)
|
15/07/2022 |
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
|
This is a clinical trial to compare and evaluate the occurrence of nonunion and malunion in double mandibular fracture patients who are treated with one load bearing fixation in anterior fracture and one load sharing fixation in posterior fracture vs two load sharing fixation. The primary outcome measure will be occurrence of nonunion at the time of followup. |