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Volume 3, Issue 10, October – 2018 International Journal of Innovative Science and Research Technology

ISSN No:-2456-2165

Bio-Degradable Versus Titanium Fixation in Oral and


Maxillofacial Surgeries-A Review Article
Dr. Harish Kumar.A Dr. Simran Kaur, Dr. Ruchika Raj
1
Professor and Head of the Department-Oral and MDS oral and maxillofacial surgery- Postgraduate Student
Maxillofacial Surgery, The Oxford Dental College Oral and Maxillofacial Surgery, The Oxford Dental College

Abstract:- Recent researches have recognised limitations Orthognathic surgery aims for predictable, fast,
of titanium plates and screws fixation post othognathic anatomical, safe and painless functional union of bones with
surgeries. Though widely used and considered as the efficient healing (2, 3). Many researches and controversies
‘gold standard’ for rigid fixation; it has its own demerits have been done to find out the ideal material for
like, interference with radiological investigations, barrier osteosynthesis for undisturbed bone healing with minimal
in growth and healing, secondary surgery for patient’s limitations. The ideal material should have a good load
need in removal of the plates and screws post healing. bearing and load sharing property, should be easy to
Although resorb able fixation systems appear manipulate and remove if necessary and should be cost
advantageous over metal systems; its stability, effective (1, 2, 3).
biodegradation and foreign body reactions are a matter
of concern and further investigation. In today’s world bio degradeable fixation system is
being used extensively in many fields such as, orthopaedics,
 Purpose:- reconstructive surgeries, neurology, gynaecology and
The purpose of this study was to determine whether cardiothoracic surgeries. They are favoured because of their
bioresorbable fixation system is superior to titanium fixation compatibility with diagnostic aids and radiation therapies.
system in orthognathic surgeries. There are no current evidences to establish the superiority of
either fixation systems on a clinical and histopathological
Keywords:- Orthognathic surgery; Bioabsorbable plate; evaluation as an ideal material for osteo synthesis.
Biodegradation; Titanium plate; skeletal stability.
The biodegradable fixation system consists of an
I. INTRODUCTION amorphous injection-molded copolymer of L-lactide/ D-
lactide/trimethylene carbonate (Fig 1). The initial tensile
The field of oral and maxillofacial surgery has strength is 452.0 +/-7.8 N). These plates resorb slowly,
witnessed a remarkable evolution in terms of fixation and maintaining 70% of their initial strength at 9 to 14 weeks,
stability post-surgery in the last 2-3 centuries. From with 42% bulk resorption by 40 weeks, and are completely
bandages to internal fixations, from implants to plating; the resorbed by 2 to 4 years (in vitro data performed by Inion
primary goal has always been restoration and healing of the for the US Food and Drug Administration). The mechanism
fractured bone to provide stability, form, function and early for resorption is hydrolysis. These plates can be bent to
mobilization post- surgery. Minimizing infection, malunion, match the curve of the bone, but they cannot be bent to
soft tissue breakdown, and technical challenges should be change vertical orientation, for example, to create a c-shaped
included in the overall management of fractures. Most arc from a straight plate. They can rotate around the central
mandibular fractures have been treated by closed reduction axis (4).
with maxillomandibular fixation, open reduction with
nonrigid fixation, and open reduction with rigid internal
fixation (1, 2, 3).

The recent trends focus more on creating a fixation


system which is stable, cheap, and durable and has no
foreign body reactions. The invention of biodegradable
fixation system is what can be termed as the Paradigm shift
in the field of faciomaxillary surgery. Although, there have
been many studies showing the success of biodegradable
plates and screws in various other sites of the body
(especially in pediatric patients where the anatomy is
unfavourable); there use in maxillofacial region still remains Fig 1:- A typical resorbable plate and resorbable screws
controversial (2). used in this study.

A rigid fixation system should be easy to place, does Laughlin et al. Resorbable Plates for Mandibular
not require an extensive training protocol, should be of Fractures. J Oral Maxillofac Surg 2007
adequate strength, should not fracture and should be
biocompatible.

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Volume 3, Issue 10, October – 2018 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
II. MATERIALS AND METHODS heals and resorbs. The second concern is of the cost
effectiveness. The titanium fixation systems are readily
A review and electronic search of several databases available and hence cheap, forming the primary choice of
were performed. 50 articles including 3937 subjects in total most of the surgeons, as compared to the biodegradable ones
were evaluated in this study. which are costlier and less readily available. The
biodegradable screws are available in multiple packs; once a
III. INCLUSION pack is used the remaining unused screws are thrown away
and hence have more wastage unlike titanium which has
Patients with maxillofacial trauma, Lefort osteotomies, none. Moreover, the biodegradable screws are prone for
BSSO (bilateral saggital split osteotomy) and zygoma more breakage and loosening in heavy loading areas, where
fractures. Patients with ASA I and II. the masticatory efficiency (load) is more. The titanium
systems offer a relatively easier application and adaptability
IV. EXCLUSION during the surgeries unlike the biodegradable ones which
need tapping, prebending and adapting of the plates and
Heavily comminuted fracture compromised medical screws after being heated at a special temperature or they
status (ASA III and IV), psychiatric disorders, cleft lip and become stiff and warp if worked on without heating (1, 2, 3, 4).
palate surgeries and those not determined suitable by the
operating maxillofacial surgeons. Various studies have been conducted and literatures
reviewed; to test the hypothesis if biodegradable fixation
V. RESULTS system is superior to titanium ones or can be used as an ideal
material for osteosynthesis.
None of the studies showed evidences of allergies,
infections, inadequate fixation in the long term followup. 103 patients were evaluated in 2 rounds of trials. The
The biodegradeable plates were bulkier as compared to the first group was given titanium fixation and stability and the
titanium plates to provide stability, but became unnoticeable second was given biodegradable fixation and stability. In the
gradually as they disintegrated. Both showed similar 1st trial, patients experienced mild discomfort in both the
stability and fixation. groups, but showed no significant statistical difference in
clinical examination. The mean scores for satisfaction for
VI. DISCUSSION both the groups were 7.43-8.63 (0-10 range). In the 2nd trial,
each group had a plate exposure postoperatively (between 3-
The major difference in the titanium and biodegradable 9 months) due to infection, loose screws and wound
fixation system is that, the titanium plates and screws do not dehiscence (titanium=3/196, biodegradable=3/165). Due to a
resorb. In many countries the removal of the plates is a high risk of bias and very limited data for primary outcome
compulsion once the fractured sements are stabilised, it was statistically insignificant (5).
whereas most of the cases for removal of the plates were
because of the following criterias: Infection, malunion, non- A Pubmed systemic search of 577 studies was done in
union, foreign body reaction or patients' need. The removal 2014. 22 studies met the inclusion criteria (8 randomised
needs general anaesthesia, re-surgeries and added medical control trials, 10 controlle clinical trials and 4 retrospective
care and cost. This disadvantage is overcome with the use of studies). 130 patients were undertaken for bsso (bilateral
biodegradable fixation systems. But because of its known saggital split ostetomy), 86 for bimaxillary surgeries and
lesser shear strength, the material is made bulkier and hence 844 patients for the evaluation of strength of various
it is palpable immediately after the surgery, but in a materials used for stability and fixation.
considerable amount of time it becomes less palpable as it
Surgeries Total number of Patients Patients with Outcome
patients with biodegradable
titanium fixation- B
fixation- A
BSSO 130 65 65 No statistical significance

Bimaxillary 86 44 42 Good vertical and occlusal


surgeries results in A

Material related 844 491 353 Group A was better as group


study (wound B had 143 screw head
dehiscence, breakage. But results were
infection, not statistically significant
breakage) (P=0.10).
Table 1. Results in Group A and Group B

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Volume 3, Issue 10, October – 2018 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
Due to a difference in the type of fixation devices used difference in total spatial changes in the condyle were seen,
and various intra operative techniques used, no significant except in the lateral-medial direction of condylar centre
decision could be made (6). (P=0.042) for bio cortical screws (9).

A randomised controlled trial of 230 injured and A randomised control trial was done to determine the
orthognathic patients was conducted between 2006- 2009. switch over of patients with biodegradable fixation to
Randomisation was done and patients were divided into 2 titanium fixation intra operatively in 230 patients. 117
groups. Patients underwent BSSO, in the control group patients were given biodegradable fixation system while 113
fixation was done with titanium plates and screws whereas patients received titanium fixation. 25 patients having
the patients in the test group were given the biodegradable biodegradable plates and screws were switched over to
fixation. No significant difference in relapse was seen titanium intra operatively. Unfortunately, due to
postoperatively in either of the groups (7). inconsistency in the number of operations and the surgeon’s
personal preferences a subjective learning curve could not
Ballon.et.al conducted a non-randomised controlled be objectified. No significant predictor variables could aid in
trial of 84 patients. 42 patients in each group were treated deciding one better than the other (10).
with titanium fixation system and biodegradable fixation
systems respectively. Both the groups gave similar post- Choi.et.at (2011), studied the post-surgical relapse of
operative results and hence it was concluded that 20 patients with maxillary surgeries stabilised with
biodegradable fixation systems should not be discouraged biodegradable fixation. No intra or post-surgical switch or
on mere fracture or palpability and more research should be removal was recorded in any patients (10).
done in the respective fields (8).
Paeng.et.al (2012), evaluated 25 patients treated with
3D image analysis of bio cortical screws fix in was mandibular setback to check for skeletal stability of titanium
done in mandibular condylar regions to check for post- and biodegradable fixations. Monocortical screws were
operative stability. 25 patients were given biocortical screws replaced with bicortical screws. No intra operative or post-
and 5 patients were given titanium screws. Pre and post- operative switch or removal was done. Both the groups
operative (6 months) images were recorded and analysed. showed similar skeletal stability (10, 11).
Stable error was 0.16mm in all the analyses. No significant
Patients with Patients with
Name and Surgeries Total number titanium biodegradab Results Significance and
Year of patients fixation le fixation conclusion
A B
8.2% (9 cases) Biodegradable fixation
Izumi BSSO 200 (67 men 90 110 fracture and system is a reliable
Yoshioka.et. and 133 breakage of alternative for titanium
al (12). women) screws in B. but is recommended in
2012 3.3% (3 cases) areas of minimal loading
fracture and
breakage in A
- 169
BSSO 169 (62 men Multiple Asymmetry and Recommended to be used
Izumi and 107 logistic open bite due to in areas of minimal
Yoshioka.et. women) regression breakage of loading and masticatory
al (13). analysis screws in forces.
2012 used to find biodegradable
the factor plates and
with screws.
dependent P=0.02
variable:
breakage of
biodegradab
le plate
fixation
system.
Alexander Orthognat 100 50 50 Lesser strength Can be used in all the
Ballon.et.al hic against situations like titanium
(4)
. surgery compressive fixation except in cases of
forces seen in maxillary elongation and
February group B (less mandibular setback.
2012 resistant to
forces of the

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Volume 3, Issue 10, October – 2018 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
tongue).
The group A
showed more
strength and
stability.
Mean follow up Biocortical screws are
Jun-Young Mandibul 50 25 25 17.8 months. less stable vertically as
Paeng .et.al ar setback (control=4 (test=5 Average compared to titanium.
(14)
. surgeries screws) biocortical stback=6.9mm. But small sample size and
screws) No hence statistically
2010 complications in insignificant.
any group.
1 case reported
with infection,
cured with
antibiotics.
34 patients Equally effective.
Philipp Jaw 66 33 33 (54%) reported Biodegradable fixation is
Stockmann.e disproport for follow up till a good alternative for
t.al (15). ion the end of the titanium for
correction study. osteosynthesis.
2010 surgeries No foreign body
reactions, no
significant
difference in
terms of
osteosynthesis
for the 8 years.
Group A Same outcomes in both
Krushna Orthognat 40 21 (20 men, 1 19 (18 men, 0 % non-union, the groups. Small sample
Bhatt.et.al hic woman) 1 woman) need of size was inconclusive of
(16)
. surgery alternative any significant finding.
treatment and Established that no need
2010 postoperative of re-operation in case of
swelling,7.7% group B.
malocclusion,
2% chronic pain,
5.2% infection,
7.7% inability to
chew food,
reoperation 31%
Group B
4.7% non-union,
0% need of
alternative
treatment
8.3%postoperati
ve
swelling,11.1%
malocclusion,
37.5% chronic
pain, 0%
infection, 11.1%
inability to chew
food.

Overall Results showed that rate


Hyo-Bin Manibular 91 (65 males 46 44 complication rate of morbidity are very low
Lee.et.al (17). fractures and 26 was 4.41%. with the use of
females) 4.26% (2 cases biodegradable plates.
2010 of infection was Suggested that both

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Volume 3, Issue 10, October – 2018 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
reported in group should be used equally as
B) they have potential for
1% (1 case of successful use in fixation
infection and 1 of mandibular fractures.
case of plate
fracture was
reported in group
A)
Maxilla was No greater morbidity was
L. K. Lefort I 40 20 20 comparatively reported when either of
Cheung.et.al osteotomy more mobile in the two fixation systems
(18)
. group B as was used and reviewed 1
compared to year post operatively.
group A.
2008 Upward
displacement of
anterior maxilla
and downward
displacement of
posterior maxilla
was seen in
group B.
No post-
operative
complications
were noted.
Biodegradable
plates were more
palpable initially
but decreased
with time.
50 After clinical and The need for secondary
Robert M. Mandibul 50 - (body, radiological surgery can be totally
Laughlin.et. ar symphysis, evaluation, 6% avoided with the use of
al (19). fractures angle and sites (3 cases) biodegradable plate and
ramus) showed signs of screw fixation system.
2007 infection.
12 screw heads
fractured were
replaced
immediately.
Group A showed No difference in post-
Fabio Class III 22 12 10 no positive operative skeletal and
Costa.et.al skeletal findings. dental stability was seen.
(20)
. cases- Group B showed
BSSO significant
setback. correlations
2006 between
maxillary
advancement and
relapse.
Lefort I 47 24 (saggital 23 (vertical Group A Slight vertical
Koichiro (saggital split ramus split (P<0.05) showed disimpaction may be
Ueki.et.al and osteotomy) osteotomy) anterior suggested in group B but
(21)
. vertical displacement. on long term follow up,
split Group B normal occlusion was
2006 osteotomy (P<0.05) showed clinically apparent.
) difference in Hence, no significant
vertical findings.
component.
Lim Kwong Maxillofa 60 30 30 Group A No statistical difference

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Volume 3, Issue 10, October – 2018 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
Cheung.et.al cial (177 (196 titanium (165 plates Infection=1.53% in subjective clinical
(22)
. osteotomi osteotomies) plates and and 658 (Wound parameters such as
es 784 screws) screws) dehiscence and discomfort, stability,
2004 loose screws) palpability and overall
Plate satisfaction.
removal=1.53%.
Group B
Infection=1.82%
(Wound
dehiscence and
loose screws)
Plate
removal=3.63%
Mandibul 22 - 22 Follow up period Mucosal healing and
Young- ar fracture (14 male, 8 averaged consolidation was normal
Wook Park managem female) upto=49.1 in all the patients.
(23)
. ent and Mean weeks. Hence, biodegradable
fixation age=26.3 Mucosal plates can be used as a
Sep 2002 years. dehiscence over reliable alternative for
devices was seen titanium.
in 2 patients.
In 1 patient the
material was
switched over to
titanium.
Carlo BSSO 40 20 20 1 year follow up No long term stability
Ferretti.et.al showed no problems.
(24)
. clinical and No statistical difference
radiological was noted in either of the
evidence of two fixation systems.
2002 wound infection Biodegradable was
or dehiscence. suggested as a good and
reliable alternative for
titanium.
BSSO, 12 - 12 All 48 screw Complete bone healing
Richard C. Mandibul BSSO=8, BSSO= 1 holes showed with no communication,
Edwards.et.a ar Mandibular patient radio locency infection, residual
l (25). symphysis symphysis underwent initially, polymer and no bone
osteotomy osteotomy=2 biopsy for followed by defects was seen.
, Lefort , Lefort histological trabecular bone
2001 osteotomy osteotomy=2 evaluation filling.
. of screw
fixation site.
Lefort
osteotomy=
2 patients
underwent
visual
exploration
of operated
site.
Table 2. Summary of studies and articles on biodegradable and titanium fixation system

VII. CONCLUSION alternative for various kinds of craniofacial reconstructive


procedures as well. The results of this review article support
With the recent advancements, biodegradable fixation the hypothesis that biodegradable fixation devices
systems come very close to being called as the ideal material have similar skeletal stability as titanium fixation when used
for fixation and osteosynthesis. In the last few decades these for trauma and orthognathic surgeries. This study also brings
plates were primarily used for orthopaedic and pediatric in to notice that biodegradable screws showed higher
patients but now its use and contribution in the field of oral chances of breakage and war page as compared to the
and maxillofacial surgery is remarkable. It is an attractive titanium screws. Stability of fixation , length of time

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Volume 3, Issue 10, October – 2018 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
required for the degradation and the possibility of foreign 11. Edwards RC, Kiely KD, Eppley BL. The fate of
body reactions still remain as a matter of primary concern, resorbable poly-L-lactic/polyglycolic acid (LactoSorb)
hence more detailed and further studies will be required in bone fixation devices in orthognathic surgery. Journal
this field to prove the superiority of biodegrade able fixation of oral and maxillofacial surgery. 2001 Jan 31;59(1):19-
system over titanium. 25.
12. Ueki K, Marukawa K, Shimada M, Nakagawa K, Alam
To summarise the review paper, several factors need to S, Yamamoto E. Maxillary stability following Le Fort I
be considered and evaluated before any fixation is declared osteotomy in combination with sagittal split ramus
superior than the other and it is the patient and the surgeon osteotomy and intraoral vertical ramus osteotomy: a
that should direct the choice of the fixation systems. comparative study between titanium miniplate and
poly-L-lactic acid plate. Journal of oral and
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