Comparison Of 3D plating using 3D printing with 3D plating without use of 3D printing in mandibular fracture

Phase 4

Completed

• Conditions: Certain early complications of trauma, not elsewhere classified,

• Registration Number: CTRI/2020/06/025916
• Lead Sponsor: Ashish Sarda

Brief Summary

**INTRODUCTION-**

The most common cause of facial trauma include road traffic accidents, assault, sports injuries, industrial accidents, and the ballistic and war injuries. Mandibular fractures used to be more common than middle third injuries. A. Rashid et. al. reported angle fractures(30%) to be most common followed by condylar(27%), parasymphyseal(27%), body(9%), symphyseal(4%), ramus(3%), and coronoid(<1%). Fracture of mandible could be favourable or unfavourable depending upon force of the muscle pull proximal and distal to the fracture.Over the years, the management of maxillofacial trauma has evolved from various forms of splinting to circum mandibular wiring, extra oral pins and semi rigid fixation with transosseus wiring followed by rigid fixation technique, which has lately given way to semi – rigid fixation with miniplate (Champy et al.). The goal in the management of facial trauma patient is to restore function & aesthetics while minimizing adverse events

The use of preoperative 3-dimensional (3D) models with virtual planning upsurges the accuracy of treatment and reduces the operating room time. 3D planning and printing is used to prepare preoperative surgical models, stents, and guides to facilitate surgery. in particular, has the potential to drastically reduce operating room time. Brett J. King et al , found that on-site 3D model fabrication with preoperative plate bending is a time-effective option to provide predictable reconstructive solutions with an associated decrease in operative time in management of mandibular fractures.Wei-fa-yang et. al. found the use of patient-specific surgical plates to be more safe and precise than conventional plates in cases of head and neck reconstruction.

Hence we intend to conduct a controlled prospective double blind study to compare the efficacy of pre-adjusted 3D plates on surgical models received after 3D printing with conventionally intraoperatively applied 3D plates in the management of mandibular fractures.

**SIGNIFICANCE OF THE STUDY**

Ø  Reduction in surgical time.

Ø  Reduction in pain during adaptation of 3D miniplate.

Ø  Accuracy of the treatment.

Ø  Prediction of outcome of the surgery.

 **AIM-**

The aim of this study is to compare the efficacy of pre-adjusted 3D plating system employing 3D printing with conventional 3D plating in the management of mandibular fractures.

**OBJECTIVES-**

1)     To compare the number of bends required to adapt the 3D plate.

2)     To compare the duration of fracture fixation (which starts from adaptation of plate to drilling of last screw).

3)     To compare the pain during the adaptation of 3D plate.

4)     To compare the occlusal stability present postoperatively.

5)     To compare for the lingual splaying postoperatively.

6)     To study the postoperative complications.

7)     To study the cost effectiveness of the techniques.

**MATERIAL & METHODOLOGY-**

**STUDY DESIGN-**

·       **Type of study**-  A controlled prospective double blind study.

·       **Sampling-**

Sample size was determined using the mean and standard deviation values from literature using the formula

n   =            2 (Zα+ Zβ)2  [s]2

d2

 where Zα is the z variate of alpha error i.e. a constant with value 1.96, Zβ  is the z variate of beta error i.e. a constant with value 0.84

Approximate estimates:

1. 80% power

2. Type I error to be 5%

3. Type II error to be 20%

4. Groups: 2

5. True difference of atleast 1.4 units between the groups

6. Pooled standard deviation of 1.1

  Substituting the values,

n   =                        2 (2.8)2  [1.1]2

(1.4)2

 n = 9.6

Approximately 10 samples per group were designated.

·       **Double blinding** will be done-

1)     patient will be allotted randomly by first co-investigator.

2)     data will be collected and analysed by second co-investigator.

Ø  The sample selected will be blinded by first co-investigator and the sample will be distributed randomly.

Ø  This will be accomplished according to the following allocation design: The first patient with a particular fracture pattern will be assigned to the experimental group & the next patient with that corresponding fracture pattern will then be assigned to the control group. In patients with 2 fractures; the other will be treated in routine fashion. In cases with 2 fractures, fractures at the same anatomic location will be used for the study comparison.

 Â·       **Patient’s selection criteria-**

The sample will be selected in age group from 21-45 years of age without discriminating on the basis of the gender, socio-economic status, religion and cast.

·       This prospective controlled prospective double blind study will be performed in Department of Oral & Maxillofacial Surgery from November 2018 to September 2021.

·       The study sample for the present controlled prospective double blind study  will be selected from the OPD of Dept. Oral And Maxillofacial Surgery from Nov 2018 to sept 2021

·       The study population will be divided into two arms [control arm (CA) & experimental arm (EA)].

   Inclusion criteria

1)     Patients who are willing to participate in the study.

2)     Patients with no significant medical history.

3)     Patients with unilateral and/or bilateral fracture present on symphyses, parasymphyses or angle of mandible region.

4)     Patients having favourable fractures and willing for open reduction and internal fixation

5)     Patient with fracture in the body of mandible region where 3D miniplate can be applied & where vital structures will not cause any interference.

  Exclusion criteria

1)     Patients not willing for participation in the study

2)     Patient having history of any systemic diseases.

3)     Pregnant and lactating patient.

4)     Patients with condylar/subcondylar/coronoid fractures.

5)     Patients with fracture in body of mandible where 3D plate can not be applied due to vital structures.

6)     Patients present with severe comminuted fractures.

7)     Patients with fractures presenting with severe soft tissue loss.

8)     Patient not willing for open reduction.

9)     Patients with craniomaxillofacial fractures.

Other materials-

·       Ehrich Arch bar (18:8 austenitic stainless steel)

·       Elastics (red)

·       Arch wire (26guage) (18:8 austenitic stainless steel)

·       Irrigant (normal saline- 0.8% sodium chloride)

·       2% lignocaine with 1:200000 adrenaline (neon)

·       General instrument tray

·       Trauma kit

·       2mm 3D titanium miniplates and titanium screws.(as per the case)[*Orto Max Mfg. Co. Pvt. Ltd.- FDA certificate no. G/28/1308 & EC certificate no. 2014-MDD/QS-029*

·       Sutures (*3-0 vicryl*, 3-0 silk)

·       Betadine

·       3D Acrylonitrile Butadiene Styrene (ABS) models. [Stratagem Paramount Consultant LLP, Mumbai- reg no, NOC attached)

·       Cone Beam Computed Tomography (CBCT) [Planmeca Romexis Viewer software]

·       3D printing machine ( ultimaker 2)

 **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 CBCT to evaluate fractures.

·       Patient will be subjected to routine investigations.

·       Fitness certificate will be taken from general physician, general surgeon or  neurosurgeon if required.

·       Oral prophylaxis will be performed.

·       Patient will be posted for surgery i.e. open reduction and internal fixation under local anaesthesia.

**DETAILED SURGICAL PROCEDURE-**

A.     The **control group**, Intermaxillary fixation will be done with the help of Ehrich Arch bar and elastics (red) under local anaesthesia(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. All the vital structures will be identified and preserved. Fracture site will be exposed, debrided and will be reduced after rigid intermaxillary fixation(IMF) with 26 guage wire. Occlusion will be established. The sharp bony prominences trimmed .2mm 3D Ti miniplate will be selected & bended as per the bony contour and adapted to the mandible and then fixed with the titanium locking screws of appropriate length using high speed drill and under copious saline. The time will be measured from adaptation of 3D miniplate to the drilling of last screw. The total no. of bends required to adapt 3D miniplate and Pain (with the help of VAS scale) will be calculated and evaluated respectively during adaptation of 3D miniplate. 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 CBCT will be taken to evaluate lingual splaying. Also occlusal stability and postoperative complications will be checked after 7 days, 3 weeks, 3 months, 6 months and then every year.

  B.     The **experimental group** will have the cone beam computed tomography (CBCT) scan of their fracture rendered as a 3D image. This image will be converted from a DICOM (Digital Imaging and Communications in Medicine) ï¬le to an STL (stereolithography) ï¬le to allow for editing, cropping, and 3D printing. A 3D model of the fractured mandible will be  printed using a 3D printer. Speciï¬cally, this printer uses the additive manufacturing technique of fused deposition modelling, whereby the 3D construct is built layer by layer from the bottom up by heating and extruding thermoplastic ABS filament. The printed model will be analysed and, in the case of displaced fractures, will be reshaped (by osteotomy) by use of a high-speed drill with a ï¬ssure bur and/or cutting wheel; it will be then reassembled with adhesive by the operating resident and supervising attending surgeon. The reassembly process will be guided by visualization of the interlocking of fracture segments, similar to in vivo fracture reduction and also with the aid of the occlusion. A plate will be selected and adapted to the printed mandible preoperatively. The plate will be processed and sterilized to allow for human implantation. The procedure will then be followed as described in the control group.

Cost effectiveness will also be evaluated between the experimental and control group at the end of the study.

  **C.** **The data will be collected as per the following variables-**

1.     Number of bends required for adaptation of 3D plates (measured by counting)

2.     Time required for plating (minutes and seconds)

3.     Pain during adaptation of 3D plate will be evaluated.

4.      Occlusal stability achieved after fixation of fracture recorded and evaluated for change and stability (3rd day, 7th day, 3 months, 6 months, 1 year follow up)

5.       Amount of reduction of lingual splay ( preoperatively and 3rd day follow up)

6.      Postoperative complications ( 7th day, 3 months, 6 months, 1 year follow

DATA COLLECTION (MASTERCHART)



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|sr noPatient noAgeSex             GroupType of fractureno of fractureEtiologylocation of 3D plateNo ofTimePain                  Occlusal stabilityLingual splayingcomplication

|(years)(M/F)Experimental (E)Control (C)bends(minutes)(VAS)3rd day7th day3rd month6th month3rd day7th day3 monts6 months

|1E-127ME-1Left Parasymphyses1RTALeft Parasymphyses317411111nonenonenone

|2E-243ME-2Symphyses1Fallsymphyses214611111nonenonenone

|3C-124MC-1Left Parasymphyses1FallLeft Parasymphyses521511111nonenonenone

|4E-321ME-3Right Parasymphyses1FallRt parasymphyses318411111nonenonenone

|5C-221MC-2Left  Parasymphyses and right angle2assaultLeft Parasymphyses528700001deranged occlusion with right sidederanged occlusion with right sidederanged occlusion with right side

|6C-326MC-3Symphyses1RTAsymphyses312411111nonenonenone

|7E-430FE-4Left Parasymphyses1FallLeft Parasymphyses418611111nonenonenone

|8C-425FC-4Right Parasymphyses1FallRight parasymphyses525611111nonenonenone

|9E-523ME-5Left Parasymphyses and right angle2RTALeft Parasymphyses213411111nonenonenone

|10C-523MC-5Right Parasymphyses1RTARight parasymphyses623711111nonenonenone

|11E-623ME-6Right Parasymphyses1RTARight parasymphyses315411111nonenonenone

|12C-628MC-6Left Parasymphyses and right angle2RTALeft Parasymphyses622601111nonenonenone

|13E-724ME-7Right Parasymphyses1FallRight parasymphyses419511111nonenonenone

|14C-739MC-7Left Parasymphyses1FallLeft Parasymphyses626611111nonenonenone

|15E-826ME-8Left parasymphyses1FallLeft Parasymphyses412411111nonenonenone

|16C-832MC-8Right Parasymphyses1RTARight parasymphyses417411111nonenonenone

|17E-922ME-9Right Parasymphyses1RTARight parasymphyses213411111nonenonenone

|18C-925MC-9Left Parasymphyses1FallLeft Parasymphyses624511111nonenonenone

|19E-1036ME-10Right Parasymphyses1assaultRight parasymphyses316511111nonenonenone

|20C-1044MC-10Left Parasymphyses and right body2FallLeft Parasymphyses729611111transient paresthesia with lower lipnonenone

RESULTS

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There were total 20patients in our study, with age ranging from 21 years to 44 years with mean ageof 28.10 years.

Among all 20 patients,6 (30%) were having left parasymphyses fracture, 8 (40%) were having rightparasymphyses fracture, 2 (10%) were having symphyseal fracture, 3 (15%) werehaving left parasymphyseal and right angle fracture and 1 (5%) was having leftparasymphyses and right body fracture.

Fall was theleading cause of fracture in 10 (50%) patients followed by road trafficaccident in 8 (40%) patients and assault in 2 (10%) patients.

3D platewas applied in 10 (50%) left parasymphyses regions, 8 (40%) right parasymphysesregions and 2 (10%) symphyseal regions.

Meanage of patients in experimental group was 27.5 years and in control group was28.5 years. There was a statistically non significant difference seen for thevalues between the groups (p>0.05) Indicatingthat age as a factor may not influence the outcome

Both, experimentaland control groups were having 9 male patients and 1 female patient each. Therewas a statistically non significant difference seen for the frequencies betweenthe groups (p>0.05) Indicatingthat sex as a factor may not influence the outcome

There was astatistically non significant difference seen for the frequencies between thegroups (p>0.05) Indicatingthat Type of fracture as a factor may not influence the outcome

There was astatistically non significant difference seen for the frequencies between thegroups (p>0.05) Indicatingthat no of fracture as a factor may not influence the outcome.

There was astatistically non significant difference seen for the frequencies between thegroups (p>0.05) Indicatingthat Etiology as a factor may not influence the outcome

3D plate was applied in 9 patients atparasymphyseal region in each group while 1 patient at symphyseal region ineach group. There was a statistically non significant difference seen for thefrequencies between the groups (p>0.05)Indicating that location of 3D plate as a factor may not influence theoutcome.

Mean number of fractures in experimental group was 1.1 while in controlgroup was 1.3.

Therewas a statistically non-significant difference seen for the values between thegroups (p>0.05) for no offracture.

Mean number of bends in experimental groupwere 3, while in control group were 5.3. There was a statistically highlysignificant difference seen for the values between the groups (p<0.01) for no of bends with higher values in Group C.

Mean operativetime required in experimental group was 15.5 minutes, while in experimentalgroup was 22.7 minutes. There was a statistically highly significant differenceseen for the values between the groups (p<0.01)for no of bends with highervalues in Group C.

Mean value for pain inexperimental group was 4.6 and in control group was 5.6. There was astatistically significant difference seen for the values between the groups (p<0.05) for Pain (VAS) with higher values in group C.

There was astatistically non significant difference seen for the frequencies between thegroups (p>0.05) for Occlusalstability at 3rd day, 7th day, 3rd month and 6thmonth.

There wassignificant/acceptable reduction of lingual splaying in all the patients withscore of +1.

There was astatistically non significant difference seen for the frequencies between thegroups (p>0.05) for complication atvarious time intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-16
• Study Completion: 2020-10-16
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1)Patients who are willing to participate in the study.
• 2)Patients with no significant medical history.
• 3)Patients with unilateral and/or bilateral fracture present on symphyses, parasymphyses or angle of mandible region.
• 4)Patients having favourable fractures and willing for open reduction and internal fixation 5)Patient with fracture in the body of mandible region where 3D miniplate can be applied & where vital structures will not cause any interference.

Exclusion Criteria

• 1)Patients not willing for participation in the study 2)Patient having history of any systemic diseases.
• 3)Pregnant and lactating patient.
• 4)Patients with condylar/subcondylar/coronoid fractures.
• 6)Patients present with severe comminuted fractures.
• 7)Patients with fractures presenting with severe soft tissue loss.
• 8)Patient not willing for open reduction.
• 9)Patients with craniomaxillofacial fractures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Number of bends required for adaptation of 3D plates (measured by counting)	3, 6 and 12 month follow up
2.Time required for plating (minutes and seconds)	3, 6 and 12 month follow up
6. Postoperative complications	3, 6 and 12 month follow up
7. Cost effectiveness.	3, 6 and 12 month follow up
3.Pain during adaptation of 3D plate	3, 6 and 12 month follow up
4.Occlusal stability	3, 6 and 12 month follow up
5. Amount of reduction of lingual splay	3, 6 and 12 month follow up

Secondary Outcome Measures

Name	Time	Method
1.Pain during adaptation of 3D plate	2.Occlusal stability

Trial Locations

Locations (1)

Government Dental College and Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Government Dental College and Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Ashish Sarda

Principal investigator

9527559979

shubhamsarda025@gmail.com