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MAXILLOFACIAL SURGERY
OSTEOSYNTHESIS MATERIALS IN MAXILLOFACIAL
Review Articles
SURGERY: REJECTION, REMOVAL, CORROSION AND
PARTICLE DETECTION RATES
Samy El Bachaoui1a , Constantinus Politis1b*
1Department of Oral and Maxillofacial Surgery, Faculty of Medicine, University of Leuven, Leuven, Belgium
MD, Master’s Student in Medicine; e-mail: samy.elbachaoui@gmail.com; ORCIDiD: https://orcid.org/0000-0003-4492-7564
a
MD, DDS, MM, MHA, PhD, Professor & Chairperson; e-mail: constantinus.politis@uzleuven.be; ORCIDiD: https://orcid.org/0000-0003-4772-9897
b
ABSTRACT https://doi.org/10.25241/stomaeduj.2020.8(2).art.4
Background Titanium is traditionally the material of choice for osteosynthesis in maxillofacial surgery and
has a wide array of application in this field. Conversely, a growing interest for alternative fixation methods
has emerged in the literature. Promising results have been reported for 3D-designed and manufactured
(CAD/CAM) titanium materials, whereas the use of biodegradable materials seems to be a more controversial
topic.
Objective To conduct a narrative review on the complications related to osteosynthesis materials in
maxillofacial surgery in terms of rejection-, removal-, corrosion- and particle detection rates.
Data Sources A literature search was performed in April 2020 using the electronic database PubMed
(National Library of Medicine, NCBI). The search included studies published between 1999 and March 2019.
Study Selection Articles were eligible for inclusion when data for the outcomes of interest were available.
Data Extraction Complication rates including rejection-, removal-, corrosion- and particle detection rates
were extracted.
Data Synthesis The data were synthesized and analyzed according to the different types of osteosynthesis
materials and fixation methods. Finally, the results were summarized and recommendations were listed for
different types of surgical indications.
KEYWORDS
Mandibular Reconstruction; Bone Plates; Postoperative Complications; Surgical Wound Dehiscence; Corrosion.
1. INTRODUCTION material [4,5]. Several studies have analyzed these
different types of materials in detail, proving each
The use of plates and screws for osteosynthesis is material has its own advantages and disadvantages.
the golden standard in maxillofacial surgery. In the However, an overview comparing the complication
literature, a wide range of different types of materials rates of the different material types is lacking. The
are used for different purposes, and each type of aim of this narrative review was to compare the
material has its own properties. Stainless steel was complication rates related to osteosynthesis
the first type of material to dominate the market, but materials and reconstruction plates in terms of
it has been left behind due to its toxic and corrosive rejection, removal, corrosion and particle detection
properties [1]. Stainless steel was replaced by tita- in soft tissues.
nium as the golden standard for osteosynthesis,
which was found to be much more efficient, because 2. MATERIALS AND METHODS
of its non-toxicity and corrosion-resistance [1]. Since
the introduction of titanium, an important evolution PubMed was searched for articles that compared
has been witnessed from standard titanium plates the different outcomes of interest from human
and screws to 3D -designed and -manufactured results concerning osteosynthesis material and
(CAD/CAM) titanium plates and screws [2,3]. Other reconstruction plates. A lot of different outcomes
contenders in this field are the bioresorbable are described in the literature, and not all authors
materials, which in theory are interesting because use the same terminology. The term ‘rejection’ could
of their bioresorbable aspects and the possibility to not be found as such in the database, therefore it
avoid a second surgery to remove the osteosynthesis was redefined as a collective term for different more
OPEN ACCESS This is an Open Access article under the CC BY-NC 4.0 license.
Peer-Reviewed Article
Citation: El Bachaoui S, Politis C. Osteosynthesis materials in maxillofacial surgery: rejection, removal, corrosion and particle detection rates.
Stoma Edu J. 2021;8(2):114-119
Received: February 20, 2021; Revised: February 28, 2021; Accepted: March 08, 2021; Published: March 20, 2021
*Corresponding author: Prof. Dr. Constantinus Politis, MD, DDS, MHA, MM, PhD, Department of Oral and Maxillofacial Surgery, University Hospitals
Leuven, Kapucijnenvoer 33, Leuven, BE-3000 Belgium
Tel/Fax: +32 16 33 24 62; e-mail: constantinus.politis@uzleuven.be
Copyright: © 2021 the Editorial Council for the Stomatology Edu Journal.
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2.1.2. Exclusion Criteria
Review Articles
m Search A:
- Population: N < 100
- Publication dates older than the past 10 years
- Study type: case reports, expert opinions, animal
studies, ex vivo experiments
m Search B:
- Study type: case reports, expert opinions, animal
studies, ex vivo experiments
3. RESULTS
3.1. Rejection- and Removal Rates
3.1.1. Titanium Materials
3.1.1.1. Miniplates vs Reconstruction Plates
2 studies were found that compared these fixation
systems. One systematic review included 5 studies
Figure 1. Flowchart of the study selection process. with 511 cases who underwent vascularized osteo-
cutaneous flap reconstruction of the mandible [6].
commonly used outcomes in the literature such as Patients with miniplates had a slightly higher rate of
‘infection’, ‘wound dehiscence’, ‘plate exposure’, or complications than did cases using reconstruction
‘screw loosening’. The search was split into 2 parts: plates (RR = 1.1), but no significant difference in
the outcomes of ‘rejection’ and ‘removal’ were complication rates was found between the groups.
searched simultaneously (search A), as well as the The second retrospective study included 682 patients
outcomes of ‘corrosion’ and ‘particle detection’ with fractures of the mandibular symphysis/body [7].
(search B). The main keywords used to build the Both plating techniques used in this study (1 large
search strategy were: “rejection”, “equipment failure”, plate vs 2 miniplates) show very good outcomes, but
“infection”, “screw loosening”, “plate extrusion”, “plate the application of a second bone plate increased the
exposure”, “wound dehiscence”, “device removal”, incidence of wound dehiscence, plate exposure, and
“plate removal” and “hardware removal” for search need for plate removal significantly. Overall, a higher
A; “corrosion”, "biocompatible materials/chemistry", rate of complications was found in the miniplate
"titanium/chemistry", “particle detection”, and groups. Therefore, one large reconstruction plate
“pigment deposition” for search B (see Appendix I is recommended above titanium miniplates as a
for full search strategy). An initial review was done treatment for vascularized osteocutaneous flap
based on title and abstract with a restriction in time reconstruction of the mandible and for fractures of
of 10 years for search A and no restriction in time for the mandibular symphysis/body.
search B. Potential articles were then examined in 3.1.1.2. Single Miniplate vs Double Miniplate
full text. A total of 15 studies were included in search 2 studies compared the use of a single- vs a double
A, and three studies in search B (Fig. 1). Articles were miniplate system in the treatment of a mandibular
eligible for inclusion when data for the outcomes of angle fracture. Both studies concluded that a single
interest were available. Further restrictions for the miniplate fixation system resulted in good stability
articles are listed in the exclusion criteria. and fewer postoperative complications, including
wound problems/dehiscence, infection, screw
2.1. Selection Criteria loosening, plate fracture and hardware removal [8,9].
2.1.1. Inclusion Criteria 3.1.1.3. 2.0 mm Locking Reconstruction Plates
m Search A: 2 studies were included that used 2.0 mm locking
- Population: N >100 reconstruction plates for mandibular reconstruction.
- Intervention: the use of osteosynthesis material/ The first study included 307 patients who had
reconstruction plates for any type of maxillofacial undergone osteocutaneous free flap reconstruction
procedure with 2.0 mm locking plate fixation following
- Outcome: infection, screw loosening, wound mandibular resection for benign or malignant
dehiscence, removal of osteosynthesis material/ neoplasia or osteoradionecrosis [10]. Plate removal
reconstruction plates was necessary in 27%, most likely due to surgical
- 10-year time restriction (2010-2020) site infection or fistula formation. The second study
- Study type: systematic reviews (and meta- included 162 patients with segmental resections
analysis), RCT, experimental controlled studies, of the mandible reconstructed with angular
observational studies. stable plates [11]. They compared 2.0 mm with 2.5
m Search B: mm locking reconstruction plates. No significant
- Intervention: the use of osteosynthesis material/ difference in complication rates was reported
reconstruction plates for any type of maxillofacial between the two types of plates. Plate removal was
procedure necessary in 28%, which is similar as the findings
- Outcome: corrosion, particle detection in lymph reported in the first mentioned study.
nodes/soft tissues A total complication rate of 28% was reported,
- Study type: systematic reviews (and meta- including loose screws (4.3%), oral- (7.4%) and extra-
analysis), RCT, experimental controlled studies, oral dehiscences with fistula formation (11.7%).
observational studies.
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Dehiscences were seen significantly more often were 35.9% in the titanium control Group vs 20.7%
Review Articles in larger defects and with longer plates. Moreover, in the CAD/CAM custom plates Group. Hardware
the rate of dehiscences was significantly higher removal was necessary in 20.2% of the titanium
in the midline. In conclusion, plate removal of 2.0 plates vs 5.6% of the CAD/CAM custom plates.
mm locking reconstruction plates is reported to be CAD/CAM custom plates utilized for rigid fixation
around 28%, and the probability of a complication during microvascular mandibular reconstruction
seems to increase with the size of the defect. demonstrated fewer complications and statistically
Therefore, when assessing complication rates, it is lower reoperation rates when compared with
important not only to take the type of osteosynthesis prebent/preformed titanium plates. The other study
material into account, but also anatomic factors such included was a systematic review and meta-analysis
as defect size or anatomic location of the fracture, including a total of 661 patients in 17 studies that
which seem to have a significantly more important compared 3D miniplates with the standard two-
impact on the success rate of the osteosynthesis miniplate technique in mandibular fractures [2].
than the osteosynthesis material itself. Mandibular fracture fixation with 3D miniplates
3.1.1.4. Locking vs Non-Locking Plates/Screws was found to decrease the risk of postoperative
2 systematic reviews with meta-analysis compared complications by 52% compared with standard
a 2.0 mm locking plate system vs a non-locking miniplates (OR 0.48). Infection and wound dehiscence
system. The double-threaded screws of locking 2.0 were less common in the 3D miniplate Group (OR
mm miniplates locking to the bone and the plate 0.58; OR 0.36, respectively), but these findings were
create a mini–internal fixator, which results in a not significant. The cumulative analysis showed a
more rigid construction with less distortion of the statistically significant difference in the outcome of
fracture or osteotomy, less screw loosening, and hardware failure, favoring 3D miniplates (OR 0.14,
less interference with bone circulation due to the p = 0.004). The results of this meta-analysis showed
slight pressing of plates against the bone. In short, that the use of 3D miniplate fixation had lower
theoretical advantages of the locking miniplate complication rates when compared with the use
system mainly include less precision required in plate of standard miniplate fixation in the management
adaptation because of the internal/external fixator, of mandibular fractures. This result was statistically
less alteration in osseous or occlusal relationship on significant. Another interesting outcome measured
screw tightening, greater stability across the fracture in this systematic review was the operative time:
sites and less screw loosening [12]. One study found 3D plate technique showed a significant time
a cumulative RR of 0.79, meaning the use of the benefit (p<0.00001). The authors concluded that
locking plate in the fixation of mandibular fractures the major advantage of the 3D miniplate technique
decreased the risk of the event (postoperative is the simultaneous stabilization of the tension and
complication) by 21% [13]. However, despite the compression zones, making the 3D plates a time-
theoretical advantages of locking systems, neither saving alternative to conventional miniplates.
of these systematic reviews found a significant 3.1.3. Biodegradable Materials
difference in postoperative complication rates The use of biodegradable materials for osteosynthesis
with the use of locking screw/plate systems when has been an interesting evolution on the market. The
compared to the use of non-locking systems in the theoretical advantage of their resorbable properties
management of mandibular fractures. sounds promising, as it could resolve the problem of
3.1.1.5. Bicortical Screws the need for a second surgery for removal of other
One study investigated the use of bicortical lag non-resorbable materials. However, this feature does
screws in 259 patients who had been treated not tell much about the clinical usefulness of such
by either BSSO or bimaxillary-osteotomy, with a materials, as it does not exclude other complications
total of 502 sagittal split osteotomies performed such as non-union, infection, hardware failure or
[14]. Removal of the osteosynthesis material was removal. One systematic review and three RCT’s
necessary in 5.6% of the cases. Bicortical screws had
were included in this report. The removal rates varied
to be removed at 2.9% of the sites, and 2.3% of the
removals were related to infection, including 1.2% of between 1.5%-16.4% in the titanium control Group
intra-oral fistula formation. In conclusion, the authors and 3.6-26.4% in the biodegradable test Group [5,15].
found that rigid fixation with 3 bicortical screws after The risk of necessity for biodegradable plate and
BSSO is reliable with a low rate of postoperative screws removal was two times higher compared to
removal of the osteosynthesis material. Other titanium plates and screws after long-term follow-up
reported incidences indicate a lower rate of removal >5y (HR 2.0, p = 0.036) [5]. Abscess formation was the
of bicortical screws than of miniplates [14]. Bicortical main reason for plate/screw removal in both groups
lag screw fixation was found to be at least as safe [4,5]. Regarding plate/screws removal after >2 and
as miniplate fixation. Moreover, because of better >5 years follow-up, the performance of the Inion CPS
fragment compression, bicortical lag screw fixation biodegradable system was inferior compared to the
offers faster bone healing.
KLS Martin titanium system following the fixation
3.1.2. 3D (CAD/CAM) Materials
2 studies that compared 3D (CAD/CAM) plates and of mandibular, Le Fort-I, and zygomatic fractures,
screws with standard titanium plates and screws and bilateral sagittal split osteotomies (BSSO) and/
were included. One retrospective study included 142 or Le Fort-I osteotomies [4,5]. Given the higher rates
subjects who underwent microvascular mandibular of plate removal, there seems to be no place for the
reconstruction [3]. Perioperative complication rates clinical usage of Inion CPS in treatment of these
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clinical usage of Inion CPS in treatment of these the presence of titanium particles, as in most similar
Review Articles
surgical indications. Another RCT included 200 studies. However, elemental analysis of pigmented
Japanese adults with jaw deformities diagnosed deposits did not confirm this assumption. The
as mandibular prognathism who underwent BSSO authors concluded that the incidence of ‘titanium
surgery [16]. The authors found complication rates deposits’ might have been overestimated in the
of 8.2% in the biodegradable Group and 3.3% in the past. Moreover, this study did not report any signs
titanium Group, including similar infection rates of of corrosion of the metal plates. These findings
3.6% and 3.3%, respectively. However, although a correspond to the results of the third study included,
greater frequency of material-related complication where no evidence of macroscopic or microscopic
was observed in the biodegradable fixation plate titanium corrosion or deterioration in the tissues was
Group, no statistically significant differences found [20]. There was no evidence to support the
were found in the incidence of material-related view that titanium miniplates should be removed
complications between the biodegradable and routinely due to corrosion up to a period of 13 years.
titanium groups. The authors suggest that the use of Overall, these findings suggest that corrosion and
biodegradable plates should be recommended only particle deposition in surrounding soft tissues are
for minimally loaded situations. clinically irrelevant and should not be considered as
a reason for the removal of titanium osteosynthesis
3.2. Corrosion- and Particle Detection Rates material on the long-term.
In this second search, the focus was mainly set on
the rates of corrosion and particle detection in soft 4. CONCLUSION
tissues. An extended search was performed for both
outcomes. Data were found reporting titanium This review provides an overview of the complication
particles detected in animal lymph nodes after rates related to different types of osteosynthesis
osteosynthesis before [17,18], and several articles materials and systems used in maxillofacial surgery,
mentioned the detection of titanium particles in including rejection-, removal-, corrosion- and parti-
locoregional lymph nodes, which are thought to be cle detection rates in surrounding tissues.
due to the corrosion of the titanium [15]. However, Reported incidences of removal of titanium fixation
reports of titanium and titanium dioxide in tissues systems in maxillofacial surgery ranged from 5,6%
adjacent to hardware and in regional lymph nodes to 28%, depending on the type of titanium fixation
have shown that only clinically insignificant amounts system and the surgical indication. When comparing
of these materials accumulate [1]. The data analysis titanium- to 3D (CAD/CAM) materials, reported
in this report focusses on the incidence of corrosion hardware removal rates are up to four times lower
and pigmentation deposits from titanium fixation for 3D manufactured materials. Moreover, the
systems. use of the 3D miniplate fixation has significantly
Thre studies that examined the outcomes of interest lower complication rates in the management of
were included. Acero et al. carried out a prospective mandibular fractures. Therefore, CAD/CAM fixation
histological study on 37 commercially pure titanium systems are recommended in the management
miniplates, removed from 23 patients who had of mandibular fractures. Biodegradable materials,
undergone surgery for maxillofacial traumatic however, are not recommended for clinical usage in
injuries or deformities [18]. Hole-like images were the treatment of traumatic fractures or osteotomies
found in 35.1% of the plates studied. The authors in the maxillofacial area, given the higher rates of
suggest that such anomalies may be corrosion effects plate removal after >5y follow-up.
in a biomaterial, with titanium-particles released to Finally, corrosion and particle deposition in the
the surrounding tissues. Dark pigmented deposits surrounding soft tissues seem to be clinically
were found in 80% of the specimens of soft tissue irrelevant and should not be considered as a reason
surrounding the analyzed plates. Defects on the for removal of the titanium osteosynthesis material
surface of the biomaterial and pigmented deposits on the long-term.
in soft tissues surrounding the plates suggest a CONFLICT OF INTEREST
higher development of corrosion in titanium than The authors declare no conflict of interest.
previously reported. In a more recent study, 60 pure
ACKNOWLEDGMENTS
titanium plates retrieved from 44 patients and 60 None.
soft tissue specimens taken from adjacent locations
AUTHOR CONTRIBUTIONS
were examined [19]. Pigmented deposits were
SEB: data acquisition, analysis and interpretation of the results,
detected in 68% of the soft tissue specimens. These author of the article. CP: substantial contribution to the
pigmented deposits were initially also attributed to conception and design of the study, revision of the manuscript.
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Appendix I: Pubmed search strategy
Review Articles
Search A:
( "Oral Surgical Procedures"[Mesh] OR "Orthognathic Surgical Procedures"[Mesh] OR "Surgery, Oral"[Mesh]
OR "Maxillofacial Prosthesis Implantation"[Mesh] OR "Orthognathic Surgery"[Mesh] OR "Facial Bones/
surgery"[MAJR] OR "Mandibular Reconstruction"[Mesh]) AND (“Fracture fixation, Internal”[MESH] OR “Fracture
fixation*”[TIAB] OR “titanium plate*”[TIAB] OR “Reconstruction plate*”[TIAB] OR “Bone plates”[MESH] OR
“Bone plate*”[TIAB] OR “Bone screws”[MESH] OR “Bone screw*”[TIAB] OR “Plate fixation*”[TIAB] OR “Fixation
plate*”[TIAB ] OR “osteosynthesis plate*”[TIAB] OR "Bone Plates*/adverse effects"[MAJR] OR “osteosynthesis
material*”[TIAB]) AND (“rejection*”[TIAB] OR "Equipment Failure"[MeSHTerms] OR "Infections"[Mesh] OR
“Infection*”[TIAB] OR “screw loosening”[TIAB] OR “loosened screws”[TIAB] OR “plate exposure”[TIAB]
OR “plate extrusion”[TIAB] OR “wound dehiscence”[TIAB] OR “Device removal”[MESH] OR “Device
removal*”[TIAB] OR “plate removal*”[TIAB] OR “Hardware removal”[TIAB]) AND (("randomized
controlled trial"[PT] OR “controlled clinical trial”[PT] OR “clinical trial”[PT] OR “comparative study”[PT] OR
"Cross-Over Studies"[Mesh] OR "Intervention Studies"[Mesh] OR random*[TIAB] OR controll*[TIAB] OR
“intervention study”[TIAB] OR “experimental study”[TIAB] OR “comparative study”[TIAB] OR trial[TIAB] OR
evaluat*[TIAB] OR “Before and after”[TIAB] OR “interrupted time series”[TIAB]) NOT ("animals"[MH] NOT
(animals[MH] AND "humans"[MH])))
Search B:
( "Oral Surgical Procedures"[Mesh] OR "maxillofacial"[TIAB] OR "Orthognathic Surgical Procedures"[Mesh] OR
"Surgery, Oral"[Mesh] OR "Maxillofacial Prosthesis Implantation"[Mesh] OR "Orthognathic Surgery"[Mesh]
OR "Facial Bones/surgery"[MAJR] OR "Mandibular Reconstruction"[Mesh]) AND ("Fracture fixation, Internal"
[MESH] OR "Fracture fixation*"[TIAB] OR "titanium plate*"[TIAB] OR "Reconstruction plate*"[TIAB] OR
"Bone plates"[MESH] OR "Bone plate*"[TIAB] OR "Bone screws"[MESH] OR "Bone screw*"[TIAB] OR "Plate
fixation*"[TIAB] OR "Fixation plate*"[TIAB ] OR "osteosynthesis plate*"[TIAB] OR "Bone Plates*/adverse
effects"[MAJR] OR "osteosynthesis material*"[TIAB]) AND ("Corrosion"[MESH] OR "Corrosion"[TIAB]
OR ("Biocompatible Materials/chemistry"[MAJR]) OR "Titanium/chemistry"[MAJR] OR "particle
detection"[TIAB] OR "pigment deposition"[TIAB]) AND (("randomized controlled trial"[PT] OR "controlled
clinical trial"[PT] OR "clinical trial"[PT] OR "comparative study"[PT] OR "Cross-Over Studies"[Mesh] OR
"Intervention Studies"[Mesh] OR random*[TIAB] OR controll*[TIAB] OR "intervention study"[TIAB] OR
"experimental study"[TIAB] OR "comparative study"[TIAB] OR trial[TIAB] OR evaluat*[TIAB] OR "Before and
after"[TIAB] OR "interrupted time series"[TIAB]) NOT ("animals"[MH] NOT (animals[MH] AND "humans"[MH])))
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Samy El BACHAOUI
MD, Master’s Student in Medicine
Department of Oral and Maxillofacial Surgery
Faculty of Medicine University of Leuven
Leuven, Belgium
CV
Samy El Bachaoui is a Master’s student in Medicine at the University of Leuven (KU Leuven) with a special interest in Oral- and
Maxillofacial surgery. He obtained his bachelor’s degree in Medicine in 2018 (cum laude), and is expected to obtain his master’s
degree in Medicine in June 2021. He has gained experience with internships in the department of Oral- and Maxillofacial Surgery
at the Geneva University Hospitals and the University Hospitals Leuven under the supervision of Professor Dr. Constantinus
Politis.
Questions
1. What fixation system has the lowest complication rates and is therefore recommended
in the management of mandibular fractures?
qa. Double titanium miniplate system;
qb. Biodegradable materials;
qc. 3D (CAD/CAM) fixation systems;
qd. Locking plates/screws.
2. The risk of postoperative complications is:
qa. Decreased by approximately 50% with 3D miniplates compared to titanium plates in the management
of mandibular fractures;
qb. Three times higher in terms of hardware removal with biodegradable materials compared to titanium
plates;
qc. Significantly lower for double miniplates compared to single miniplates;
qd. Not significantly different for double titanium miniplates compared to a large reconstruction plate in
the management of mandibular fractures.
3. Regarding plate/screws removal after >5 years follow-up following fixation of
traumatic fractures and osteotomies in the maxillofacial area, the performance of the
biodegradable system was assessed as:
qa. Superior compared to the titanium system, therefore the clinical usage of a biodegradable fixation
system in the treatment of these surgical indications is strongly recommended;
qb. Superior compared to the titanium system, therefore the use of biodegradable plates should be
recommended for maximally loaded situations;
qc. Equal compared to the titanium system, therefore the use of biodegradable plates could be a clinically
useful alternative in the treatment of these surgical indications;
qd. Inferior compared to the titanium system, therefore there seems to be no place for the clinical usage of
biodegradable systems in the treatment of these surgical indications.
4. Which of the following statements is true regarding corrosion and/or particle
deposition in surrounding soft tissues?
qa. Corrosion rates of titanium miniplates are clinically relevant and should be considered as a reason for
the removal of titanium osteosynthesis material on the long-term;
qb. Corrosion rates of titanium miniplates are clinically irrelevant and should not be considered as a reason
for the removal of titanium osteosynthesis material on the long-term;
qc. Pigment deposition rates in surrounding soft tissues of titanium plates of up to 90% have been
reported and should therefore be considered as a reason for the removal of titanium osteosynthesis
material on the long-term;
qd. Reports of titanium deposits show no evidence of particle accumulation in tissues adjacent to titanium
hardware nor in regional lymph nodes.
Stoma Edu J. 2021;8(2): 114-119 pISSN 2360-2406; eISSN 2502-0285 119