| CTRI Number |
CTRI/2020/06/025860 [Registered on: 14/06/2020] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison and Assessment of Newly Designed Z Plate with 3D Plate for fixation of Lower Jaw Fractures. |
|
Scientific Title of Study
|
Evaluation Of a Novel Design Z Plate With 3D Plate Semi Rigid Fixation for the Management of Mandibular Symphysis, Parasymphysis and Angle fracture- 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 |
DrSuleka Ranganath |
| Designation |
PG Student |
| Affiliation |
Government Dental College Mumbai |
| Address |
Dept no.118, Oral and maxillofacial surgery Government dental college and Hospital, saint George Hospital campus near Chatrapati shivaji terminus , PD Mello road , fort,Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9740410976 |
| Fax |
|
| Email |
suleka.ranganath@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prajwalit Kende |
| Designation |
HOD and Prof Oral and Maxillofacial surgery |
| Affiliation |
government dental college mumbai |
| Address |
Department of oral and maxillofacial surgery government dental college saint george hospital campus PD Mello road near CST fort mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9324715824 |
| Fax |
|
| Email |
prajwalitkende1979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suleka Ranganath |
| Designation |
PG Student |
| Affiliation |
government dental college mumbai |
| Address |
Dept no.118, Oral and maxillofacial surgery , Government dental college and Hospital , Saint george Hospital campus , near Chatrapati shivaji terminus PD Mello road fort, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9740410976 |
| Fax |
|
| Email |
suleka.ranagnath@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of oral and maxillofacial surgery government dental college saint george hospital campus PD Mello road near CST mumbai |
|
|
Primary Sponsor
|
| Name |
Government Dental College and Hospital Mumbai |
| Address |
Government dental college and Hospital, Saint george Hospital campus, near Chatrapati shivaji terminus PD Mello Road , Fort, Mumbai |
| Type of Sponsor |
Other [Government dental college mumbai ] |
|
|
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 |
| DrSuleka Ranganath |
Government Dental college mumbai |
Dept no.118, Oral and maxillofacial surgery Government dental college and Hospital, saint George Hospital campus near Chatrapati shivaji terminus , PD Mello road , fort,Mumbai
Mumbai
MAHARASHTRA |
9740410976
suleka.ranganath@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committe Government Dental College and Hospital Mumbai |
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 |
| Intervention |
Fixation of Mandibular Symphysis, Parasymphysis and Angle fracture of Mandible using Z plate |
Under Local Anaesthesia , After detailed History, Consents, Fracture site will be exposed along with preservation of vital structures . Fracture Segments will be Reduced and fixed with Z Plate . |
| Comparator Agent |
Fixation of Mandibular Symphysis, Parasymphysis and Angle fracture using 3D Plate |
Under Local Anaesthesia , After detailed Case History, consents ,Fracture site will be exposed along with preservation of vital structures, Fracture segments will be reduced and fixed with 3D Plate |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to participate in the study.
2. Patient with unfavourable symphysis, parasymphysis and angle fractures.
3. Patient with favourable fractures and willing for open reduction and internal fixation
4. Patients with no significant medical history.(ASA I and ASA II)
5. Patients with unilateral and/or bilateral fracture present on symphysis, parasymphysis and angle region of mandible. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing for participation in the study
2. Patients with severe systemic conditions.( ASA III And ASA IV)
3. Pregnant and lactating patient.
4. Patients with condylar/subcondylar/coronoid/ mid face fractures.
5. Patients presenting with severe comminuted fractures.
6. Patients with fractures presenting with severe soft tissue loss.
7. Patient not willing for open reduction.
8. Patients with craniomaxillofacial fractures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the duration of fracture fixation in Symphysis, Parasymphysis and angle region of mandible.
2. To check Paraesthesia of lower lip.
3. To compare the occlusal stability postoperatively. |
1.Immediate
2.at 7th day,1month,3months,6months
3. At 7thday 1month,3months,6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare for the lingual splaying postoperatively.
2. To study the cost effectiveness of both semi rigid fixation techniques.
3.To study any postoperative complications |
1.preop and 3rd post op day
2.Immediate
3. 7thday,1st month,3 month,6 month |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2020 |
| 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="2"
Months="5"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Malhotra K, Sharma A, Giraddi G, Shahi AK. Versatility of titanium 3D plate in comparison with conventional titanium miniplate fixation for the management of mandibular fracture. JOMS. 2012,1;11(3):284-90. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The maxillofacial region is the most exposed part of the body and is more vulnerable to trauma. Trauma to the maxillofacial region involves skeletal, dental and soft tissue components of the face. Mandible is the most common fractured bone in face with a frequency of 36% to 70% .Each half of mandible can be divided into 7 portions -the Condylar head and neck, Coronoid process, Ramus, Angle, Body, Parasymphyseal and Symphyseal region in the midline . Among the various etiologies i.e assault, road traffic incidents(RTA), self fall , work place injury and sports related injury, RTA accounts for 62.76% and self fall for 18.08 of cases% . The most common site of fracture was the Angle (30%) followed by Parasymphysis (27%), Condyle (27%), Body(9%), Symphyseal (4%), Ramus (3%) and then the Coronoid(≤1%). Recently, Farmand and Dupoirieux developed the concept of 3D miniplates whose shape is based on the principle of the quadrangle as a geometrically stable configuration for support . Patiguli et.al noted that 3 Dimensional miniplates is the best option for mandibular fractures. However the study conducted by mohit Agarwal et al concluded that 3D miniplate system is difficult to adapt and difficult to use in the fractures involving mental nerve . Manoj kumar et al reported that 3D plate was much broader, has to be bent in 3 Dimensions and had lack of stability in oblique fractures. Thus to overcome the shortcomings of 3D plate , A novel design of Z Plate has been designed. An In-vitro study was performed that evaluates the biomechanical behaviour of newly designed Z plate using Finite Element Analysis . After finite element analysis the design has shown better stability And strength as compared with 3D plate . Hence we intend to conduct a prospective randomized control study to compare a novel design Z Plate with 3D plate for open reduction and internal fixation of mandibular symphysis, parasymphysis and angle fractures .
SIGNIFICANCE OF THE STUDY – -Easy adaptation thus reducing surgical time. -Minimal damage to neurovascular bundle. - Better strength and stability of plate - New design will be added for management of mandibular symphysis, parasymphysis, angle fractures.
AIM- Aim of this study is to evaluate the performance of the novel design Z plate and to compare it with the 3D plate for open reduction and internal fixation of mandibular Symphysis , Parasymphysis and angle fractures.
PRIMARY OBJECTIVES– 1. To compare the duration of fracture fixation in Symphysis, Parasymphysis and angle region of mandible. 2. To check Paraesthesia of lower lip. 3. To compare the occlusal stability postoperatively.
SECONDARY OBJECTIVES- 4. To compare for the lingual splaying postoperatively. 5. To study the cost effectiveness of both semi rigid fixation techniques. 6. To study any postoperative complications . If the study provides good results, in future we intend to use in fractures of different sites on mandible
METHODOLOGY- -Patients will be randomly divided into two arms (experimental arm and control arm) by first co-investigator. - All the information about the study will be revealed to the patient in the language he/she understands and an informed consent will be obtained prior to surgery from patient/relative/guardian. - A detailed case history will be taken for all patients (Annexure ‘B’), followed by clinical examination and occlusal radiograph to evaluate fractures. - Patient will be subjected to routine investigations. - Fitness certificate if required will be taken from general physician, general surgeon or neurosurgeon. - Oral prophylaxis will be performed. - Patient will be posted for surgery i.e. open reduction and internal fixation under local anaesthesia.
PROCEDURE DETAILS - A. The control group, Intermaxillary fixation will be done with the help of Ehrich Arch bar and elastics (red) under local anesthesia(LA). After that patient will be posted for surgery. Elastics will be removed. Under all aseptic precautions and under LA, incision will be made as per the fracture site. According to the protocol, all the vital structures will be identified. Fracture site will be exposed, debrided and will be reduced after rigid intermaxillary fixation(IMF) with 26 gauge wire. Occlusion will be established. 3D Plate will be selected & bended as per the bony contour and adapted to the mandible and then fixed with the titanium screws of appropriate length using high speed drill and under copious saline. The time will be measured from adaptation of 3D Plate to the drilling of last screw. The total no. of bends required to adapt 3D Plate will be calculated and evaluated respectively during adaptation of Z Plate. Then the operated site will be flushed with betadine solution and checked for any foreign bodies. The IMF will be released. Wound will be closed in layers with 3-0 vicryl and 3-0 silk sutures. postoperative medications and instructions will be given to the patient. Patient will be recalled after 3 days and occlusal radiograph will be taken to evaluate lingual splaying. Also occlusal stability and postoperative complications will be checked after 3rd day,1 month, 3 months, 6 months B. The experimental group. The experimental group will receive the newly designed Z plate in the fracture site . All the procedure will then be followed as described in the control group.
C. The data will be collected as per the following variables-
1. Time required for plating (minutes and seconds) 2. Paraesthesia of lower lip 3. Number of bends required for adaptation of plate. 4. Occlusal stability achieved after fixation of fracture recorded and evaluated for change and stability 5. Amount of reduction of lingual splay ( preoperatively and 3rd day follow up) 6. Postoperative complications 7. Cost effectiveness.
Patient data-
| sr.no |
Date |
name of the
patient |
reg no |
age(yrs) |
sex(M/F) |
group |
type of
fracture |
no.of fracture |
etilogy |
location of the
plate |
time[min] |
pain (VAS) |
paresthesia |
no.of bends |
occlusal
stability |
lingual splaying |
complications |
| |
|
|
|
|
|
experimental group[E] |
Control group[C] |
|
|
|
|
|
|
immediate |
7th day |
1 month |
3 month |
6 month |
|
3rd day |
7th day |
3 month |
6 month |
3rd post op day |
7th day |
1 month |
3 month |
6month |
| 1 |
25-09-2020 |
ashraf shaikh |
10796 |
27 |
M |
E-1 |
|
left parasymphysis
and right angle |
2 |
assault |
left
parasymphysis |
12 |
6 |
0 |
1 |
0 |
0 |
0 |
2 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 2 |
07-10-2020 |
vaishali kombekar |
10240 |
24 |
F |
E-2 |
|
left parasymphysis
and right angle |
2 |
assault |
left
parasymphysis |
24 |
4 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 3 |
13-10-2020 |
sahil parkar |
464795 |
24 |
M |
|
C-1 |
left parasymphysis |
1 |
fall |
left
parasymphysis |
18 |
5 |
0 |
1 |
0 |
0 |
0 |
5 |
1 |
1 |
1 |
1 |
0 |
none |
none |
none |
none |
| 4 |
25-11-2020 |
anarul shaikh |
10841 |
19 |
M |
E-3 |
|
left parasymphysis
and right angle |
2 |
fall |
left
parasymphysis |
22 |
4 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 5 |
27-11-2020 |
Arbaaz Khan |
77811 |
21 |
M |
|
C-2 |
left parasymphysis
and right angle |
2 |
assault |
left
parasymphysis |
28 |
7 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
1 |
none |
none |
none |
none |
| 6 |
22-12-2020 |
yogesh parwani |
14339 |
32 |
M |
E-4 |
|
left parasymphysis
and right angle |
2 |
RTA |
left
parasymphysis |
18 |
7 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 7 |
29-12-2020 |
mansi chavhan |
12438 |
41 |
F |
E-5 |
|
right parasymphysis
and left angle |
2 |
fall |
right parasymphysis |
21 |
5 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 8 |
04-01-2021 |
Abdul karim shaikh |
15939 |
26 |
M |
|
C-3 |
symphysis |
1 |
RTA |
symphysis |
12 |
4 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
none |
none |
none |
none |
| 9 |
08-01-2021 |
Bhavana shukla |
9089 |
25 |
F |
|
C-4 |
right
parasymphysis |
1 |
fall |
right parasymphysis |
25 |
6 |
0 |
1 |
1 |
0 |
0 |
5 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 10 |
12-01-2021 |
akshay suvasiya |
21403 |
23 |
M |
|
C-5 |
left parasymphysis
and right angle |
2 |
RTA |
left
parasymphysis |
13 |
4 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
1 |
1 |
0 |
none |
none |
none |
none |
| 11 |
14-01-2021 |
babasaheb archar |
33606 |
28 |
M |
|
C-6 |
left parasymphysis
and right angle |
2 |
RTA |
left
parasymphysis |
22 |
6 |
0 |
0 |
0 |
0 |
0 |
6 |
1 |
1 |
1 |
1 |
0 |
none |
none |
none |
none |
| 12 |
19-01-2021 |
shyam shinde |
325 |
36 |
M |
E-6 |
|
symphysis fracture |
1 |
RTA |
symphysis |
16 |
6 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 13 |
21-01-2021 |
hakim mubin |
28379 |
27 |
M |
|
C-7 |
left parasymphysis |
1 |
RTA |
left
parasymphysis |
13 |
4 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 14 |
26-01-2021 |
raj jadhav |
5669 |
21 |
M |
|
C-8 |
right
parasymphysis |
1 |
fall |
right parasymphysis |
18 |
4 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
1 |
0 |
none |
none |
none |
none |
| 15 |
28-01-2021 |
aman shaikh |
30607 |
24 |
M |
|
C-9 |
right
parasymphysis |
1 |
fall |
right parasymphysis |
19 |
5 |
0 |
1 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 16 |
05-02-2021 |
somnath ingale |
279 |
28 |
M |
E-7 |
|
right parasymphysis
and left angle |
2 |
fall |
right parasymphysis |
20 |
4 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 17 |
23-02-2021 |
Abrar shaikh |
1143 |
28 |
M |
E-8 |
|
left
parasymphysis |
1 |
fall |
left
parasymphysis |
16 |
5 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 18 |
26-02-2021 |
sai tamhankar |
504 |
26 |
M |
|
C-10 |
left
parasymphysis |
1 |
fall |
left
parasymphysis |
12 |
4 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
1 |
1 |
-1 |
none |
none |
none |
none |
| 19 |
06-05-2021 |
kishan sharma |
2713 |
45 |
M |
E-9 |
|
left
parasymphysis |
1 |
RTA |
left
parasymphysis |
20 |
5 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 20 |
03-03-2021 |
pooja ubale |
17121 |
30 |
F |
|
C-11 |
left
parasymphysis |
1 |
fall |
left
parasymphysis |
18 |
6 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 21 |
17-03-2021 |
balaram avachar |
9898 |
36 |
M |
|
C-12 |
right
parasymphysis |
1 |
assault |
right parasymphysis |
16 |
5 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
1 |
1 |
1 |
0 |
none |
none |
none |
none |
| 22 |
21-06-2021 |
Shreedhar |
1542 |
42 |
M |
E-10 |
|
left parasymphysis |
1 |
RTA |
left
parasymphysis |
20 |
5 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 23 |
22-07-2021 |
Tinkuram |
9345 |
36 |
M |
E-11 |
|
Right
Parasymphysis |
1 |
fall |
right parasymphysis |
15 |
6 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
| 24 |
28-07-2021 |
mohd.Ashlam |
9915 |
32 |
M |
E-12 |
|
right
parasymphysis |
1 |
fall |
right parasymphysis |
18 |
4 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
1 |
none |
none |
none |
none |
|