| CTRI Number |
CTRI/2017/12/010760 [Registered on: 05/12/2017] Trial Registered Prospectively |
| Last Modified On: |
05/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison between a new interdental wiring technique with currently used technique in the treatment of facial jaw fractures |
|
Scientific Title of Study
|
A comparison between a novel intermaxillary fixation technique and Ivy eyelet intermaxillary fixation technique in the treatment of minimally displaced jaw fractures in terms of time taken, stability of IMF and incidence of glove perforation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Ahad G Khan |
| Designation |
Assistant Professor |
| Affiliation |
Govt Dental College and Hospital Aurangabad |
| Address |
OPD no. 123, Dept of Oral and Maxillofacial Surgery Govt Dental College and Hospital Aurangabad
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9552002731 |
| Fax |
|
| Email |
drabdulahadkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Ahad G Khan |
| Designation |
Assistant Professor |
| Affiliation |
Govt Dental College and Hospital Aurangabad |
| Address |
OPD no 123, Dept of Oral and Maxillofacial Surgery Govt Dental College and Hospital Aurangabad
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9552002731 |
| Fax |
|
| Email |
drabdulahadkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Ahad G Khan |
| Designation |
Assistant Professor |
| Affiliation |
Govt Dental College and Hospital Aurangabad |
| Address |
OPD no 123 Dept of Oral and Maxillofacial Surgery Govt Dental College and Hospital Aurangabad
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9552002731 |
| Fax |
|
| Email |
drabdulahadkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal Investigator Dr Abdul Ahad G Khan OPD no 123, Dept of Oral and Maxillofacial Surgery Govt Dental College and Hospital Aurangabad Maharashtra 431001 |
|
|
Primary Sponsor
|
| Name |
Dr Abdul Ahad G Khan |
| Address |
OPD no 123 Dept of Oral and Maxillofacial Surgery Govt Dental College and Hospital Aurangabad |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Abdul Ahad G Khan |
Govt Dental College and Hospital, Aurangabad |
OPD no. 123, first floor, Dept of Oral and Maxillofacial surgery, Govt Medical College campus, Dhanwantari Nagar, Aurangabad
Aurangabad
MAHARASHTRA |
9552002731
drabdulahadkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of Govt Dental College and Hospital Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Maxillofacial trauma patients who are otherwise healthy and not medically compromised, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ivy eyelet wiring technique |
It is the contemporary technique used for intermaxillary fixation in facial jaw fractures |
| Intervention |
Novel intermaxillary fixation technique |
it is the new intermaxillary fixation technique to be used in the treatment of facial jaw fractures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Minimally displaced jaw fractures either maxilla and/or mandible screened clinically and confirmed radiographically by means of a digital OPG
2. Occlusion should be minimally disturbed/deranged
3. Favourable fractures
4. Multiple fractures with at least 3-4 teeth firmly fixed to basal bone in all fragments
5. Undisplaced Condylar fractures in which occlusion is minimally deranged that can be manipulated into satisfactory occlusion under local anesthesia manually
6. Zygomatico-maxillary complex fractures not requiring open reduction/ fixation
7. Jaw fractures with good proximal contacts between the teeth
8. Healthy patients free from medical compromise such as diabetes, hypertension, B asthma, Epilepsy, drug allergies etc
|
|
| ExclusionCriteria |
| Details |
1. Unfavourable fractures
2. Fractures with grossly deranged occlusion
3. Mixed dentition period for need of good dento-alveolar support
4. Comminuted jaw fractures
5. Dento-alveolar fractures
6. Displaced condylar fractures requiring open reduction internal fixation
7. Partially/ totally edentulous jaw fractures
8. Jaw fractures with open proximal contacts between the teeth
9. Medical problems such as bronchial asthma, epilepsy that preclude IMF
10. Oral mucosal conditions that pose significant restrictions on operators maneuverability such as oral submucous fibrosis .
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the new intermaxillary fixation wiring technique with eyelet wiring for intermaxillary fixation of jaw fractures based on:
1. Time duration required for application of IMF in minutes measured from the point in time when the first wire placement is started to the finished tucking of IMF wires interdentally
|
Measured at the time of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Stability of IMF over the treatment span assessed by maintenance/ loosening of IMF wires
2. Incidence of glove perforation assessed by glove inflation by water post intervention
|
Stability of IMF is assessed on a weekly basis post intervention.
Glove perforation is assessed immediately post intervention
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/12/2017 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Abstract published in the Journal of Maxillofacial and Oral Surgery (2017) 16 (suppl): S262
DOI 10.1007/s12663-017-1052-5 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction
Intermaxillary fixation (IMF) is used in the
treatment of jaw fractures since times immemorial. It is necessary to orient
the jaw bones into satisfactory dental occlusion before fixation of jaw
fractures. However the contemporary techniques used for IMF are tedious, time
consuming, traumatic for the patient as well as the operator, difficult for
oral hygiene maintenance, with inherent risk of transmission of blood-borne
diseases and increased duration of
surgical anesthesia. So, this study was designed in which a novel technique of
IMF is compared with the contemporary technique for IMF, Ivy eyelet IMF, to
evaluate and compare the efficacy and inherent associated complications.
Aims
& Objectives
The aim of the study is to compare the new intermaxillary
fixation wiring technique with eyelet wiring for intermaxillary fixation of jaw
fractures. The objectives will include comparison based on
1. Time
duration required for application of IMF
2. Stability
of IMF over the treatment span and
3. Incidence
of glove perforation.
Materials & Methods
A sample of 80 subjects from amongst the maxillofacial trauma
patients referred to the OPD/IPD of Dept
of Oral and Maxillofacial Surgery, GDCH Aurangabad fulfilling the specified
inclusion criteria will be randomly divided into test and control group and
will be blinded off the methodology used. Inter Maxillary Fixation will be done
by 2 or more different surgeons with comparable surgical/wiring skills under
local anesthesia/GA. IMF will be placed
for 4-6 weeks depending on the facts of the case, with weekly follow-up .
The observations will be made as follows:
1. The time taken for wiring is from
the application of first wire till the completion of IMF and will be noted down
in minutes.
2. Stability of IMF will be assessed by
maintenance of IMF wires as otherwise there will be loosening of the IMF wires.
3. Incidence of Glove perforation will
be assessed by inflating the glove post-wiring by water/saline to look for
leakages.
4. Digital OPG will be taken at 4
months and 6 months to assess the
healing of the fracture as evidenced by disappearance/reduction in radiolucency
of the fracture line.
|