Comparison and Assessment of Newly Designed Z Plate with 3D Plate for fixation of Lower Jaw Fractures.
- Conditions
- Fracture of mandible,
- Registration Number
- CTRI/2020/06/025860
- Lead Sponsor
- Government Dental College and Hospital Mumbai
- Brief Summary
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.noDatename of the patientreg noage(yrs)sex(M/F)grouptype of fractureno.of fractureetilogylocation of the platetime[min]pain (VAS)paresthesiano.of bendsocclusal stabilitylingual splayingcomplications
|experimental group[E]Control group[C]immediate7th day1 month3 month6 month3rd day7th day3 month6 month3rd post op day7th day1 month3 month6month
|125-09-2020ashraf shaikh1079627ME-1left parasymphysis and right angle2assaultleft parasymphysis12601000211111nonenonenonenone
|207-10-2020vaishali kombekar1024024FE-2left parasymphysis and right angle2assaultleft parasymphysis24400000411111nonenonenonenone
|313-10-2020sahil parkar46479524MC-1left parasymphysis1fallleft parasymphysis18501000511110nonenonenonenone
|425-11-2020anarul shaikh1084119ME-3left parasymphysis and right angle2fallleft parasymphysis22400000511111nonenonenonenone
|527-11-2020Arbaaz Khan7781121MC-2left parasymphysis and right angle2assaultleft parasymphysis28700000500001nonenonenonenone
|622-12-2020yogesh parwani1433932ME-4left parasymphysis and right angle2RTAleft parasymphysis18700000111111nonenonenonenone
|729-12-2020mansi chavhan1243841FE-5right parasymphysis and left angle2fallright parasymphysis21500000311111nonenonenonenone
|804-01-2021Abdul karim shaikh1593926MC-3symphysis1RTAsymphysis12400000300000nonenonenonenone
|908-01-2021Bhavana shukla908925FC-4right parasymphysis1fallright parasymphysis25601100511111nonenonenonenone
|1012-01-2021akshay suvasiya2140323MC-5left parasymphysis and right angle2RTAleft parasymphysis13400000211110nonenonenonenone
|1114-01-2021babasaheb archar3360628MC-6left parasymphysis and right angle2RTAleft parasymphysis22600000611110nonenonenonenone
|1219-01-2021shyam shinde32536ME-6symphysis fracture1RTAsymphysis16600000511111nonenonenonenone
|1321-01-2021hakim mubin2837927MC-7left parasymphysis1RTAleft parasymphysis13400000311111nonenonenonenone
|1426-01-2021raj jadhav566921MC-8right parasymphysis1fallright parasymphysis18400000500010nonenonenonenone
|1528-01-2021aman shaikh3060724MC-9right parasymphysis1fallright parasymphysis19501000411111nonenonenonenone
|1605-02-2021somnath ingale27928ME-7right parasymphysis and left angle2fallright parasymphysis20400000311111nonenonenonenone
|1723-02-2021Abrar shaikh114328ME-8left parasymphysis1fallleft parasymphysis16500000411111nonenonenonenone
|1826-02-2021sai tamhankar50426MC-10left parasymphysis1fallleft parasymphysis1240000040011-1nonenonenonenone
|1906-05-2021kishan sharma271345ME-9left parasymphysis1RTAleft parasymphysis20500000511111nonenonenonenone
|2003-03-2021pooja ubale1712130FC-11left parasymphysis1fallleft parasymphysis18600000411111nonenonenonenone
|2117-03-2021balaram avachar989836MC-12right parasymphysis1assaultright parasymphysis16500000511110nonenonenonenone
|2221-06-2021Shreedhar154242ME-10left parasymphysis1RTAleft parasymphysis20500000411111nonenonenonenone
|2322-07-2021Tinkuram934536ME-11Right Parasymphysis1fallright parasymphysis15600000311111nonenonenonenone
|2428-07-2021mohd.Ashlam991532ME-12right parasymphysis1fallright parasymphysis18400000411111nonenonenonenone
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 28
- Patients who are willing to participate in the study.
- Patient with unfavourable symphysis, parasymphysis and angle fractures.
- 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.
- Patients not willing for participation in the study 2.
- Patients with severe systemic conditions.( ASA III And ASA IV) 3.
- Pregnant and lactating patient.
- Patients with condylar/subcondylar/coronoid/ mid face fractures.
- Patients presenting with severe comminuted fractures.
- Patients with fractures presenting with severe soft tissue loss.
- Patient not willing for open reduction.
- Patients with craniomaxillofacial fractures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To compare the duration of fracture fixation in Symphysis, Parasymphysis and angle region of mandible. 1.Immediate | 2.at 7th day,1month,3months,6months | 3. At 7thday 1month,3months,6months 2. To check Paraesthesia of lower lip. 1.Immediate | 2.at 7th day,1month,3months,6months | 3. At 7thday 1month,3months,6months 3. To compare the occlusal stability postoperatively. 1.Immediate | 2.at 7th day,1month,3months,6months | 3. At 7thday 1month,3months,6months
- Secondary Outcome Measures
Name Time Method 1.To compare for the lingual splaying postoperatively. 2. To study the cost effectiveness of both semi rigid fixation techniques.
Trial Locations
- Locations (1)
Government Dental college mumbai
🇮🇳Mumbai, MAHARASHTRA, India
Government Dental college mumbai🇮🇳Mumbai, MAHARASHTRA, IndiaDrSuleka RanganathPrincipal investigator9740410976suleka.ranganath@yahoo.co.in