Biodegradable fixation of mandibular fractures in children: Stability

and early results

Kaan C. Yerit, MD, DMD,a Sibylle Hainich, MD, DMD,b Georg Enislidis, MD, DMD,a
Dritan Turhani, MD,a Clemens Klug, MD,a Gert Wittwer, MD, DMD,a Michael Öckher, MD, DMD,a
Gerhard Undt, MD, DMD, PhD,c Christian Kermer, MD, DMD,c Franz Watzinger, MD, DMD, PhD,c
and Rolf Ewers, MD, DMD, PhD,d Vienna, Austria
MEDICAL UNIVERSITY OF VIENNA

Objective. The aim of this study was to assess the safety and efficiency of biodegradable self-reinforced (SR-PLDLA) bone plates
and screws in open reduction and internal fixation of mandible fractures in children.
Study design. Thirteen patients (5 female, 8 male; mean age 12 years, range 5-16 years) were operated on various fractures
of the mandible (2 symphyseal, 6 parasymphyseal, 4 body, 3 angle, 1 ramus, 2 condylar fractures). The mean follow-up time was
26.4 months (range 10.9-43.4 months). Intermaxillary fixation was applied in cases with concomitant condylar fractures up to 3
weeks.
Results. Primary healing of the fractured mandible was observed in all patients. Postoperative complications were minor and
transient. The outcome of the operations was not endangered. Adverse tissue reactions to the implants, malocclusion, and
growth restrictions did not occur during the observation period.
Conclusions. Pediatric patients benefit from the advantages of resorbable materials, especially from faster mobilization and the
avoidance of secondary removal operations. Based on these preliminary results, self-reinforced fixation devices are safe and
efficient in the treatment of pediatric mandible fractures. However, further clinical investigations are necessary to evaluate the
long-term reliability.
(Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2005;100:17-24)

In contemporary maxillofacial surgery, biodegradable
bone fixation is becoming an alternative treatment in
trauma, orthognathic, and craniofacial surgery.1-25 The
fast development of new biodegradable materials
expands the application to areas where a few years
ago only the rigid fixation by metallic plates and screws
was possible. New biomechanical properties of bio-
degradable devices lead to a growing number of
indications and even high load-bearing areas such as
the human mandible can be treated with these new
devices under certain circumstances.8,13-17,21-24 The
main advantage of internal resorbable fixation of
fractures is the gradual transfer of load to the healing
bone during resorption and the elimination of any
secondary operation for implant removal, which is
common with metallic implants. The clinical realization
a
Resident, University Hospital of Cranio-Maxillofacial and Oral
Surgery, Medical University of Vienna, Austria.
b
Resident, Clinic of Dentistry, Medical University of Vienna.
c
Assistant Professor, University Hospital of Cranio-Maxillofacial and
Oral Surgery, Medical University of Vienna.
d
Professor and Head, University Hospital of Cranio-Maxillofacial
and Oral Surgery, Medical University of Vienna.
Received for publication Jul 11, 2004; returned for revision Oct 6,
2004; accepted for publication Nov 19, 2004.
Available online 12 March 2005.
1079-2104/$ - see front matter
Ó 2005 Elsevier Inc. All rights reserved.
doi:10.1016/j.tripleo.2004.11.013
of these advantages has increased the interest in
developing biodegradable implants, and clinical studies
report on the successful use of these devices in pediatric
craniofacial surgery.10,11,19,20,25
Maxillofacial fractures are less common in children
than in adults. The incidence ranges from approximately
1% in children under the age of 5 years up to 8% in
children younger than 12 years of age.26-29 Mandibular
fractures are reported to belong to the most frequent
facial fractures in pediatric patients.28 The conservative
approach in the treatment of maxillofacial trauma in
children was common for many reasons. The presence
of tooth buds and the elasticity of the pediatric bone were
factors for splinting and/or intermaxillary fixation as
a standard treatment of mandibular fractures in children
during deciduous dentition. Open reduction and internal
fixation were avoided in most cases so as not to harm the
teeth. The development of microplates and miniplates
made it possible to apply these fixation materials in
pediatric traumatology as well. This technology offers
improved initial stability but its appliance in children is
limited in the mandible not only due to the above-
mentioned reasons but also due to concerns over growth
restrictions, stress shielding, corrosion, and palpability.
Resorbable osteofixation materials promise to overcome
these problems.
This clinical study analyzes stability and efficiency of
biodegradable self-reinforced bone plates and screws in

17
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18 Yerit et al July 2005

Table I. Patient data

Fracture site
Patient Gender Age, y Follow-up, mo (1 not operated) Intermaxillary fixation, wk
1 F 13.1 43.4 body 1 ramus no
2 M 11.5 42.8 parasymphyseal (1 condyles) yes, 3
3 M 13.2 42.7 Parasymphyseal no
4 F 14.6 34.1 parasymphyseal 1 body no
5 F 9.6 31.2 Condyle yes, 2
6 M 13.9 27.0 parasymphyseal (1 condyle) yes, 3
7 M 12.3 26.8 parasymphyseal 1 angle no
8 F 15.3 26.8 Angle no
9 M 16.0 22.0 Body no
10 M 15.8 12.3 parasymphyseal 1 angle no
11 M 6.7 11.7 symphysis (1 condyles) yes, 2
12 F 9.7 11.1 Condyle yes, 2
13 M 5.0 10.9 symphysis 1 body no

F, Female; M, male; y, years; mo, months; wk, weeks.

internal fixation of mandibular fractures in a pediatric
patient population.
PATIENTS AND METHODS
Data were collected of 13 patients (Table I) who
underwent open reduction and internal fixation with
biodegradable self-reinforced (SR-) polyisomers of D-
and L-lactic acid with 30% D-lactide and 70% L-lactide
(SR-PLDLA) (BioSorb FX, Linvatec Corp, Largo, Fla)
during the period from June 2000 to May 2004. Five
patients were female and 8 were male. The mean age
was 12 years (range 5-16 years) at the time of surgery.
Eighteen fractures (2 symphyseal, 6 parasymphyseal, 4
body, 3 angle, 1 ramus, 2 condylar) were fixed internally.
Exclusion criteria were surgical treatment initiated more
than 3 days after injury, the presence of active infection,
and systemic disease. The operation technique was the
same for most patients. After access and identification
of the fracture, fixation of the bone segments was
obtained through the appliance of 2 biodegradable
plates. In very young patients, 1 single plate was used to
fix the fracture ends such as in patient nos. 5, 11, 12, and
13. The fracture ends were anatomically reduced and
fixed with clamps while the mandible was in strong
occlusion with the maxilla. The plates were adapted to
the bone surface and then holes for the insertion of the
screws were drilled. After tapping with a special tap and
flushing of the hole, the screws were inserted.
Fracture fixation had to be altered in special cases
because of anatomical reasons. Patient no. 13 (Fig 1 and
Fig 2) is a case that justified an alteration of the
treatment: the mandible of this 5-year-old boy was fixed
with a single resorbable 6-hole plate at the most inferior
border of the symphysis and a 6-hole microplate was
applied cranially without harming the tooth buds. This
microplate was removed 4 months postoperatively after
initial healing of the mandible. The resorbable plate was
left in situ. The fracture of the mandibular body was also
reduced and fixed with a single 6-hole plate. Also, in 2
other cases of a fractured and dislocated condyle
(patient nos. 5 and 12), the fracture was fixed with 1
single 5-hole plate from a preauricular approach (Fig 3
and Fig 4). Maxillomandibular fixation was applied for
2 weeks following physical therapy.
Wound closure was achieved with nonresorbable
suture material. Postoperative intermaxillary fixation
(IMF) was applied in patients with concomitant
condylar fractures. In these cases, IMF was maintained
for 2 weeks if the condyles were also operated on, and
for 3 weeks if not. All patients were treated with routine
antibiotic prophylaxis consisting of penicillin, clinda-
mycin, or cephalosporin for 10 days postoperatively.
Appropriate analgesics were also prescribed. All
patients were maintained on a strict soft chew diet for
14 days and gradually advanced as tolerated.
The routine follow-up consisted of clinical and
radiological controls (panoramic radiograph, cephalo-
gram) immediately postoperatively and in 4-, 8-, 12-,
and 24-week intervals and thereafter in 6-month
intervals. Reduction, stability, displacement, diastasis,
and visibility of the fracture line and drill channels and
ossification of the mandibular fracture were observed
carefully. Patients were also monitored for eventual
clinical signs of nonhealing of soft and hard tissue, such
as inflammation, formation of fistula, and disturbances
of occlusion and sensibility.
RESULTS
All fractures were united. The mean follow-up time
was 26.4 months (range 10.9-43.4 months). In all cases,
the self-reinforced fixation system provided satisfactory
stability to enable bone healing during the initial phase.
No complications occurred during the follow-up period.
Initial healing of soft and hard tissue was uneventful in
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Volume 100, Number 1 Yerit et al 19

Fig 1. Panoramic radiograph of a 5-year-old boy (patient no. 23) fixed with resorbable plates at the symphysis and right mandibular
body. The microplate in the symphyseal region is visible before removal after 4 months of bone healing. The resorbable plates are
radiolucent and not visible.

Fig 2. Same boy after more than 10 months postoperatively. The microplate has been removed and the mandible shows normal
bone healing.

all patients. In 4 cases hypesthesia of the lower lip was
observable up to 3 months postoperatively. Thereafter
no disturbances of sensibility were observed. The
postoperative follow-up was not endangered by in-
fection, exposition of implant material, diastasis, or
nonunion. The routine radiographic controls showed
good bone healing without any signs of instability of the
fixation. The ossification and restoration of the fractured
mandibular bone without any complications could be
monitored in the panoramic radiographs. The drill holes
for the insertion of the screws, however, were visible in
all radiographs as radiolucent areas in all patients

20 Yerit et al
Fig 3. Intraoperative view shows the insertion of a resorbable
screw for the fixation of an SR-PLDLA plate after the
reduction of the condylar fracture in patient no. 12.
through the entire follow-up period (Fig 5 and Fig 6).
During the follow-up, no evidence of malocclusion or
growth restrictions was observed.
DISCUSSION
Craniomaxillofacial surgery has undergone great
progress with the development of conventional titanium
plates and screws for osteofixation. However, osteofixa-
tion with these metal devices is sometimes associated
with drawbacks.30-38 Some patients develop allergic
reactions to the metal, which can cause inflammation
and the need for removal of the metal. Protruding screws
and plates under the skin can be irritating and may be
painful. Stress shielding, especially after rigid plate
fixation, has been reported and may be a cause for
weakening of bone after the removal of the implant.
Corrosion and release of metal ions can be a reason to
remove the osteofixation devices. In most cases,
especially in pediatric patients, this is associated with
hospitalization and an increased burden on the health
care system. Metal fixation can also cause growth
disturbances and it is therefore recommended to remove
metallic devices in infants as early as possible after
healing of the bone. The use of resorbable materials in
treatment of craniosynostosis in the growing infant also
avoids a translocation of the material endocranially,
which is seen with metallic devices through the natural
growth of the infant skull. The material is resorbed
before its translocation. Other possible risks would
include the interference with imaging techniques such
as computed tomography scanning and magnetic
resonance imaging or with postoperative radiotherapy.
Biodegradable materials do not interfere with radio-
diagnostic techniques because of their radiolucency. All
the mentioned risks of metal fixation devices can be
avoided by the application of resorbable materials. They
promise initial strength followed by eventual degrada-
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July 2005
Fig 4. Intraoperative situation after reduction and fixation of
the condylar fracture with resorbable plating system.
tion, resorption, and elimination from the body. The
good tissue acceptance enables a normal healing pattern
of the bone. Avoidance of secondary implant removal
operations and therefore reduction of overall costs are
advantages for the patient with emphasis on the
pediatric patient. The amount of trauma is reduced,
not only physical but psychological as well.
The clinical application of resorbable polymers has
been proved in numerous studies. Various materials,
such as polylactic acid (PLA), polyglycolic acid (PGA),
and polydioxanone (PDS) and their copolymers, are
commercially available currently. Besides the applied
SR-PLDLA, copolymers of lactic and polyglycolic acid
have to be mentioned among many other materials, like
the copolymer (PLGA) consisting of 82% PLLA and
18% PGA that is commercially available as Lactosorb
(Walter Lorenz Surgical, Jacksonville, Fla) and Biosorb
PDX (Linvatec Corp), a blend consisting of 80% PLLA
and 20 % PGA. This material is especially recommended
for children because of faster resorption and less risk
of growth impairment for the fast-growing skeleton.39
PDS is used mainly as suture material but also as pins
and screws. The strength of biodegradable materials is
usually achieved by the production of bulky and large
devices to provide adequate mechanical stability. The
development of the self-reinforcing (SR) manufacturing
technique40 allowed the production of biodegradable
implants with higher strength and with durability and
biocompatibility enabling undisturbed bone healing.
Biomechanical properties of fixation plates and screws
can be improved by this technique. These plates and
screws show higher mechanical strength in spite of
smaller sizes by the reinforcement of the polymer matrix
with elements of the same material in orientation of
the axis. In contrast to other resorbable devices, cold
bending without heating is possible. These self-
reinforced biodegradable bone plates and screws
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Volume 100, Number 1
Fig 5. This panoramic radiograph of patient no. 1 shows the fracture after internal fixation with 2 resorbable 6-hole plates at the
right parasymphyseal region 1 month postoperatively. The fracture line and the screw holes are visible.
promise suitable strength and adequate stability for
fracture fixation in even high-load fracture sites like
the mandible.16,22-24 Nevertheless, adverse effects have
also been reported on the use of biodegradable materials.
The degradation products of pure PGA or PLA may
cause inflammatory reactions as described by studies of
Böstman et al41 and Böstman.42 Bergsma et al43 found
high crystalline remnants of degradation products in
a patient group operated on zygomatic fractures. The
sterile abscesses in the operation area had occurred about
3 years after operation. Compared to pure PLLA, the
copolymer PLDLA as used in this study and consisting
of 30% D-lactide and 70% L-lactide isomers promises
a shorter resorption time of 2 to 3 years. No clinical
complications have been reported with this material so
far.
Several clinical studies report on the use of bio-
degradable materials in pediatric craniofacial surgery.
Eppley et al11 used a copolymer of PLLA/PGA for the
reconstruction of pediatric craniofacial deformities in
100 patients between 4 and 15 months of age over
a period of 2.5 years. The authors concluded that the
material was safe and effective for use in pediatric
craniofacial application. Kurpad et al19 described their
experiences with the use of a polymeric biodegradable
system for the correction of congenital pediatric
craniofacial malformations in 15 cases. No complica-
tions were observed and the authors concluded that the
Yerit et al 21
results of their study supported the use of resorbable
fixation systems in the correction of congenital cranio-
facial deformities. Serlo et al20 used SR-plates and
screws for the fixation in cranioplasties in children
without any complications in the early follow-up period
of 6 months. In 2004, Cohen et al25 performed resorbable
osteofixation for reconstruction in pediatric surgical
procedures including craniosynostoses, fibrous dyspla-
sia, cranial defects, and encephaloceles. All patients
experienced maintenance of stable bone fixation fol-
lowed by bone healing and the material used was
concluded as effective in such indications.
With the introduction of the self-reinforcement
technique,40 the manufacturing of suitable plates and
screws with sufficient stability and rigidity for the
treatment of fractures in even high-stress areas seems to
be possible. These devices also have the potential to alter
and improve the treatment of pediatric trauma. Major
advantages of rigid mandible fixation with these devices
compared to conservative nonoperative treatment are
avoidance or shorter intermaxillary fixation and a fast
mobilization of the temporomandibular joint. The
overall patient comfort is beneficial especially in the
pediatric patient. Nutrition is possible or impaired only
for a short time. The clinical application of resorbable
osteofixation devices in the mandibular region is
reported in a limited number of studies. Experiences
in pediatric patients are rare. Due to the lower strength

22 Yerit et al
Fig 6. Almost 4 years after resorbable fixation in patient no.1. The consolidated mandible does not show any signs of traumatic
injury, only some visible screw holes at the inferior border of the mandible may indicate a fracture history of this patient.
of the resorbable materials compared to conventional
metal osteofixation systems it was not possible to apply
them on mandibular fractures. With the self-reinforcing
technique, the strength of plates and screws could be
improved and the osteofixation of even high-load sites is
reported now by several authors. In a report by Turvey
et al,21 good results were achieved in the stabilization of
mandibular and maxillary osteotomies. The authors
concluded that self-reinforced PLDLA was a reliable
fixation material in orthognathic osteotomies as it was
proven successfully also by several other study
groups.8,13-15,17,21 No serious complications were re-
ported in any of these studies and long-term stability was
comparable to clinical reports on metallic devices. In
craniofacial traumatology, a study of Kallela et al16 was
one of the first to report on lag screw fixation in 11
patients without IMF. Healing was also uneventful in
this study. In 2002, Kim and Kim22 published a study
about biodegradable fixation of mandibular fractures in
49 patients. In symphysis fractures, 2 plates were used,
whereas in body and angle fractures, 1 single plate. Six
patients experienced complications such as infection,
premature occlusal contact, and temporomandibular
disorder. Osteomyelitis occurred in 1 patient 4 months
after surgery. In most cases, IMF was applied up to 23
days. Yerit et al23 reported about 22 patients with various
fractures of the mandible followed up for an average
of 49.1 weeks (22-78 weeks) after internal fixation
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July 2005
with SR-PLDLA plates and screws. They used 2 plates
to stabilize fractures of the symphysis, body, angle, and
the condyles of the mandible. Mucosal exposure of the
plates occurred in 2 cases. The healing pattern of all
other fractures was uneventful. Ylikontiola et al24
concluded in a pilot study with 10 patients that SR-
PLDLA plates and screws were reliable for internal
fixation of anterior parasymphyseal mandibular frac-
tures. In 4 cases with concomitant condylar fractures,
IMF was applied for 3 weeks. One case of plate exposure
resulting in minor infection was observed. The other
patients displayed no evidence of disturbances in bone
and soft tissue healing.
The presence of tooth buds during deciduous
dentition in children complicates the appliance of fixa-
tion plates in the treatment of mandibular fractures. In
our patient group, 4 children were in the early deciduous
dentition and none were infants. The standard fracture
treatment for adults, the internal osteofixation with
plates and screws, is either not an option or only possible
in children whose teeth are safely away from the
positioning areas. In general, plate fixation will be
possible in the symphyseal and parasymphyseal region
where screws will not endanger the teeth after the
eruption of the incisors and the canines. The inferior
border of the mandible is the best place for the
positioning of a plate in these fracture sites. Angular
fractures together with fractures of the ramus and the
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Volume 100, Number 1
condyles can be internally fixed with miniplates or
microplates, whereas the body of the mandible remains
a complicated operation site due to close tooth buds in
young children. In older children the application of
fixation plates is no problem, but the treatment of
younger children is still a demanding procedure. Due to
the small and vulnerable anatomy, a single plate is
considered to fulfill the requirements of a stable fixation
in very young patients. Single plates were used in 4
patients (Table I: patient nos. 5, 11, 12, and 13) due to
the early deciduous dentition and fragile anatomy; all
other patients were treated with 2 plates at each fracture
site. Sometimes the modality of treatment had to be
modified and adapted to the individual situation to
achieve best results as in patient no. 13 (Fig 1 and Fig 2).
The stability of single plates was high enough to enable
stable fixation and primary bone healing.
In this study, we found no short-term growth
abnormalities and occurrence of facial asymmetry as
documented in pediatric mandibular fractures.44 The
preliminary results were promising and complications
did not occur. We assume that the resorption of the
implants will not endanger mandibular growth. The
resorption of the material seems not to influence bone
repair and growth. One important reason may be the
soft bone of children. It is still remodeling and it has
a higher osteogenetic capacity than that of adults.
This enables fast and solid bone healing during the
immobilization period. Long-term data are not avail-
able and further investigations are necessary to report
the results, not only concerning degradation and
biocompatibility but also further growth and facial
symmetry.
CONCLUSION
While our follow-up period was too short and the
patient population is too small to determine the long-
term effects of fracture treatment with biodegradable
fixation systems, our preliminary impression is favor-
able. The self-reinforced devices showed sufficient
rigidity and stability to enable initial bone healing of
the mandible. The stability of the plates and screws was
high enough for fracture fixation in this study group.
Tissue intolerance, growth restrictions, and occlusal
abnormalities were not seen, and occlusal relationship
could be restored in all cases. Benefits for children are
evident since patient comfort is higher. Advantages of
resorbable fixation materials in general and the benefits
for the pediatric patient in particular, including the
reduction in time for long-term stability, the diminished
immobilization period, and elimination of painful
procedures for implant removal make biodegradable
osteofixation devices an attractive option in pediatric
fracture fixation. However, potential problems relating
Yerit et al 23
to resorption and bone growth have to be observed
carefully and investigated in further clinical studies.
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Reprint requests:
Kaan C. Yerit
Medical University of Vienna
University Hospital of Cranio-Maxillofical and Oral Surgery
Wahringerstrasse 18-20
Vienna 1090
Austria
Kaan.yerit@meduniwien.ac.at