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© 2022 EDIZIONI MINERVA MEDICA European Journal of Oral and Maxillofacial Surgery 2022 December;6(3):122-7
Online version at https://www.minervamedica.it DOI: 10.23736/S2532-3466.22.00297-1

ORIGINAL ARTICLE

Retrospective study of patients submitted to reconstruction

with customized temporomandibular joint prostheses
Luiz F. LEANDRO 1, Kelly C. MARINE 2, Guilherme OMIZZOLO 3 *,
Ariane LOPES 1, Wouter HOUTHOOFD 4, Fernando M. ORNELLAS 5

1Serviceof Oral and Maxillofacial Surgery and Traumatology, Santa Paula Hospital, São Paulo, Brazil; 2Residency in CBMF, Service
of Oral and Maxillofacial Surgery and Traumatology, Santa Paula Hospital, São Paulo, Brazil; 3Unit of Oral and Maxillofacial
Surgery and Traumatology, PUC RS, Joaçaba, Brazil; 4Office of Clinical Affairs, Materialise NV, Leuven, Belgium; 5Unit of Oral
and Maxillofacial Surgery and Traumatology, Service of Oral Maxillofacial Surgery and Traumatology, UNIMED Hospital, Volta
Redonda, Brazil
*Corresponding author: Guilherme Omizzolo, Unit of Oral and Maxillofacial Surgery and Traumatology, PUC RS, Avenida Santa Teresinha 243, 8960-000
Joaçaba, Brazil. E-mail: guilhermeomizzolo@gmail.com

A B S T RAC T
BACKGROUND: The aim of this study was to present a retrospective review of cases through questionnaires, evaluating the impacts of custom-
ized prostheses for patients with temporomandibular joint (TMJ) disease.
METHODS: A retrospective study of TMJ reconstruction with TMJ prosthesis, customized by Engimplan/Materialise Company (Rio Claro,
Brazil), evaluated a total of 22 adult patients aged over 30 years (73%), over a period of 2 years, with 31 prostheses implanted with varied diag-
noses (bone degeneration, ankylosis, orthognathic sequelae, and trauma) obtained with preoperative imaging tests (computed tomography) and
clinical evaluation of the patient.
RESULTS: The pre- and postoperative results were measured by OHIP Table I4, maximum interincisal opening (MIO), eating ability, pain, sat-
isfaction, and prosthesis safety (infection, sensitivity, paranesthesia, and stability of prosthetic components) within 15 days, 3 months, 6 months,
and 1 year. Results demonstrate that the installation of customized prostheses, through what was designed in the customized virtual presurgical
planning, achieved positive patient outcome 1 year after surgery, impacting significantly on the absence of pain (average VAS 1±1.1/10), with
MIO (36±4 mm) and eating ability (VAS 9.3±0.8/10) within normality and stability of prosthetic components (no revisions), significantly im-
proving all OHIP-14 parameters (average from 22±2 preoperatively to 3±0.8 after 1 year, P<0.01) and being able to affirm the creation of state
of the art in customized TMJ prostheses.
CONCLUSIONS: Future research is needed to address the long-term safety and performance of this TMJ prosthesis.
(Cite this article as: Leandro LF, Marine KC, Omizzolo G, Lopes A, Houthoofd W, Ornellas FM. Retrospective study of patients submitted to recon-
struction with customized temporomandibular joint prostheses. Eur J Oral Maxillofac Surg 2022;6:122-7. DOI: 10.23736/S2532-3466.22.00297-1)
Key words: Temporomandibular joint; Reconstructive surgical procedures; Prostheses and implants.

T emporomandibular joints (TMJ) can be affected by

various dysfunctions or pathologies, resulting in a very
large range of signs and symptoms, such as headache, otal-
dylar resorption, arthritis (by systemic comorbidity, e.g.,
lupus, rheumatoid).6, 7 TMJs, when affected by some of
these pathologies, can evolve with severe alteration of the
gia, cervicalgia, tinnitus, joint dislocations, among others.1-3 mandible head and consequently decrease in posterior man-
Although clinical treatments are indicated in most cases, dibular height, compromising the functions of the entire
some can only be adequately treated through customized stomatognathic system.7, 8 This work aims to present a ret-
total prostheses or stock.1, 3-5 Most common indications for rospective review of cases through questionnaires, evaluat-
TMJ arthroplasty are arthrosis (degenerative diseases) by ing the impacts of customized prostheses for patients with
ankylosis, sequela of previous treatments, idiopathic con- TMJ disease, developed by Engimplan (Rio Claro, Brazil).

122 European Journal of Oral and Maxillofacial Surgery December 2022

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TMJ RECONSTRUCTION WITH CUSTOM PROSTHESIS LEANDRO

Materials and methods Statistical analysis

Study design and patient population Demographic and safety data were described using total
numbers and percentages relative to the total amount of
This study is a retrospective descriptive study that described patients and prostheses. Average MIO, VAS, and OHIP
and analyzed all patients’ clinical data that have received scores were calculated with their standard deviation, mini-
the Engimplan TMJ prosthesis in the last 2 years (between mum and maximum value. The non-parametric Wilcoxon
April 5, 2016, and October 28, 2019) within the partici- signed-rank test for paired samples was used for comparing
pating institutes in Brazil. The study enrolled subjects be- the pre- and postoperative significance of MIO, VAS, and
tween the age of 18 and 95 years, all of which were under OHIP scores, with a P<0.05 indicating a significant differ-
the care in the 3 participating institutes, with a minimum ence. For each time point, only patients, for which both pre-
of 6-month up to 1-year follow-up postsurgery. This study and postoperative results were available, were included.
was conducted according to the principles stated in the
Declaration of Helsinki and approved by the Institutional
Ethics Committee review (CEP Hospital Santa Paula). Discussion

Data collection Demographics

To perform the study, a questionnaire developed by the After data collection, there is a prevalence of women
sponsor (Materialise) was completed. Data were obtained (54.5%) aged 30 years or older (72.2%), predominantly
regarding the number of medical records, age, gender, sur- bilateral surgery (59.1%). Bone degeneration and tumor
gical indication, primary surgery or revision, radiographic are the most common causes for the approach (40.9% and
evaluation, and occlusion evaluation. A list of expected 22.7%, respectively), with no previous surgeries in half of
complications was solicited with a questionnaire per pa- the cases addressed (Table I). The average follow-up time
tient, prosthesis, and timepoint. Treatment, outcome, and was 10.1 months (min-max 6-12 months).
potential relationship with the prosthesis were recorded. Prothesis safety
Maximum interincisal opening (MIO) is typically mea-
sured between the incisal tips at the maximum unassisted There is no removal or revision of any of the prostheses,
opening. In patients with anterior open bites, the amount of and analysis of postoperative radiographs indicated 97%
open bite should be subtracted for the MIO measurement, (34/35) success in the placement of the prostheses ac-
and in deep bites, the amount of vertical overlap should be cording to the presurgical plans (Table II). Most patients
added to the measurement for accurate determination of experienced neurological complications (peripheral neu-
MIO.9-11 Oral Health Impact Profile (OHIP-14) question-
naire measures peoples’ subjective perceptions of disability Table I.—Demographics: number and frequency of data on gen-
and discomfort caused by oral conditions.12, 13 The subjects der, age, diagnosis, type of surgery, side, and number of previous
are asked how frequently they had experienced the problem surgeries.
in the last month for each question. Responses are rated us- Parameters Variables
N. of patients
ing a Likert-type scale (0 = never; 1 = hardly ever; 2 = oc- (N.=22) %

casionally; 3 = fairly often; 4 = very often). Zero indicates Gender Male 10 45.5
Female 12 54.5
the absence of any problems, while high scores point to se- Ages at the time of surgery <30 6 27.3
verely impaired oral health.12 The patient’s ability to eat was > or = 30 16 72.7
scored on a Visual Analog Scale (VAS) between 0 and 10 Primary diagnosis Bone degeneration 9 40.9
points, with 0 completely liquid diet and 10 a regular, solid Tumor 5 22.7
Ankylosis 3 13.6
diet, before surgery and postoperative follow-up visits. The Orthognathic sequel 2 9.1
subjective pain sensation of the patient was scored on VAS Sequel of trauma 3 13.6
between 0 and 10 points, with 0 the absolute absence of Side of surgery Unilateral 9 40.9
pain, and 10 the greatest pain, before surgery and on post- Right side 3 13.6
Left side 6 27.3
operative follow-up visits. The patient’s satisfaction with Bilateral 13 59.1
surgical procedure was scored on a VAS between 0 and 10 Number of previous surgeries None (0) 11 50.0
points, with 0 no satisfaction and 10 absolute satisfaction. <2 7 31.8
This score is only measured at the postoperative time points. > or = 2 4 18.2

Vol. 6 - No. 3 European Journal of Oral and Maxillofacial Surgery 123

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LEANDRO TMJ RECONSTRUCTION WITH CUSTOM PROSTHESIS

Table II.—Number and frequency of revision or removal of pros- Table III.—List of complications per patient and per prosthesis.
theses and evaluation of proper placement. Neuropathies and paresthesia could occur in several regions,
N. of N. of therefore total of complications per region is larger than total
Variables patients prostheses amount reported per patient/prosthesis. Complications already
N.=22 % N.=35 % reported before surgery were considered pre-existing conditions
and were not considered.
Prosthesis reviewed or removed
Yes 0 0 0 0 Adverse effects Per patient (N.=9) Per prosthesis (N.=14)
No 22 100 35 100 Peripheral neuropathy (sensory) 9 13
Proper placement of the prosthesis Labial - 2
according to the presurgical plan Chin - 1
Yes 21 95.5 34 97.1 Ocular - 9
No 1 4.5 1 2.9 frontal - 11
Peripheral neuropathy (motor) 8 12
Labial - 2
ropathies and/or paresthesia) immediately or 15 days after Chin - 1
surgery (Table III). Most neurological complications oc- Ocular - 8
frontal - 11
curred in the frontal and/or ocular region. Also, edemas Paresthesia 7 11
were reported in 8/9 patients or at 11/14 prosthesis sides. Labial - 3
All complications were successfully treated and resolved Chin - 2
after 3 months at the latest. No complications were report- Ocular - 6
frontal - 9
ed after 6 months or 1 year after surgery. No infections Edema 8 11
or other complications were reported. The surgeon consid- Frey Syndrome 0 0
ered all complications to be related to the procedure and Superficial infection 0 0
not to the TMJ prosthesis. Other 0 0

Table IV.—Average patient outcome measures per timepoint. Eating ability scale with 0 completely liquid diet and 10 a normal, solid
diet. OHIP-14 scale where the quality of life is inversely proportional to the value obtained, i.e., the higher the values, the worse the
patient’s quality of life.
Parameter Timepoint N. Mean SD Min Max P value
MIO (mm) Preoperative 17 31.6 10.0 0 40
15 days 17 20.9 3.2 15 28 0.008*
3 months 15 29.7 4.2 24 37 0.18
6 months 15 33.6 4.0 28 40 1
1 year 11 36.4 3.5 30 41 0.76
Eating ability (VAS) Preoperative 21 6.1 2.6 0 10
15 days 17 3.3 2.2 0 7 0.007*
3 months 16 7.3 1.7 5 10 0.09
6 months 18 8.7 1.4 6 10 <0.001*
1 year 11 9.3 0.8 8 10 0.002*
OHIP-14 Preoperative 15 27.9 11.4 18 52
15 days 14 10.9 2.1 8 14 0.001*
3 months 13 8.0 1.6 6 10 0.001*
6 months 12 5.4 2.5 2 10 <0.001*
1 year 11 3.0 0.8 2 4 0.008*
Pain (VAS) Preoperative 21 7.0 2.2 1 10
15 days 16 3.1 2.0 3 6 <0.001*
3 months 15 1.8 1.3 1 3 <0.001*
6 months 19 1.4 1.2 0 3 <0.001*
1 year 12 1.0 1.1 0 3 0.003*
Satisfaction (VAS) Preoperative 17 4.1 3.6 0 8
15 days 17 8.6 1.7 3 10 <0.001*
3 months 16 9.1 0.9 7 10 <0.001*
6 months 19 9.6 0.7 8 10 <0.001*
1 year 12 9.5 0.9 7 10 0.001*
Satisfaction scale where 0 is no satisfaction, and 10 absolute satisfaction. Pain scale where 0 is the absolute absence of pain, and 10 the strongest pain.
Max: maximal value; Min: minimal value; MIO: maximum interincisal opening; N.: number of patients included in the measure; OHIP-14: Oral Health Impact Profile;
SD: standard deviation; VAS: Visual Analogue Scale.
*P value indicating statistically differences with preoperative value, based on a Wilcoxon signed-rank test for paired samples (P<0.05).

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TMJ RECONSTRUCTION WITH CUSTOM PROSTHESIS LEANDRO

Maximum interincisal opening

45 12

After 15 days of surgery, there is a significant decline in 40

10
the total maximum interincisal opening from an average 35

Eating ability (VAS)

32±10 mm to 21±3 mm (Table IV; Figure 1), which is al- 30 8

MIO (mm)
ready expected due to the trismus caused by the surgical 25
6
20
procedure and kinesiophobia of the patient. Mouth open-
15 4
ing after the third month initiates an upward curve, indi-
10
cating that there is a recovery of the initial values (average 2
5
MIO of 36±4 mm), or even higher than initially in some
0 0
patients. 0 2 4 6 8 10 12
Time (months)
mouth eating
Eating ability opening ability

Also, the eating ability decreased 15 days after surgery, Figure 1.—Comparison of maximum interincisal opening (MIO) (blue
line, left axis, in mm) and eating ability (red line, right axis, where val-
from 6.1 to 3.3, but then showed an improvement from ues close to 0, represent strictly liquid diet and 10 normal diet).
the third month, similar to the mouth opening measure- Error bars represent the standard deviation.
ments coinciding with the trend in MIO (Table IV; Figure
1). Considering that the maximum value of food capacity
is 10, mean values close to the limit were obtained after 40 12

6 and 12 months of surgical procedures. The scores im-

Pain satisfaction scale (VAS)

35
10
proved significantly after 6 and 12 months compared to the 30
OHIP-14 score

8
preoperative score (P<0.01). 25

20 6
OHIP 14
15
4
Before surgery, patients scored their oral health on average 10
2
22.6±1.5. A significant decrease in OHIP-14 score is ob- 5

served from 15 days after surgery on (11.6±1.7), decreas- 0 0

0 2 4 6 8 10 12
ing further to an average score of 3±0.8 one year after sur- Time (months)
gery (P<0.01) (Table IV; Figure 2).
Figure 2.—Ratio of the mean satisfaction, pain, and OHIP-14 scores.
Pain scale The results of OHIP-14 should be read inversely, the worse the quality
of life in relation to oral health. Error bars represent the standard devia-
tion. Visual Analogue Scores (VAS) lie between 0 and 10 points, with
Patients reported significantly less pain 15 days after sur- 0 the absolute absence of pain/satisfaction, and 10 the maximum pain/
gery (3.1±2.0) compared to presurgery (7.0±2.2) and de- satisfaction.
creasing further to an average score of 1.0±1.1 one year
after surgery (P<0.01) (Table IV; Figure 2). thies/paresthesia or edemas that resolved after 3 months
Satisfaction scale at the latest were considered not to be related to the TMJ
prosthesis but more generally to the surgical procedure.
The data obtained indicate that the patients were, on aver- To interpret these results considering the state-of-the-art,
age, in the preoperative period satisfied (average score of a systematic literature search on clinical research of simi-
4.1), but in the subsequent evaluations of 15 days, 3, 6, and lar TMJ prosthesis procedures was performed. Based on a
12 months presented a significantly higher average than predefined search strategy, 1325 publications were iden-
in the preoperative period (P<0.05) with an average score tified from 3 clinical literature databases (PubMed, Web
above 9 (Table IV; Figure 2). of Science, and Embase). After screening based on pre-
defined criteria, 122 publications were selected. Seventy-
General observations
one of those did not report any complications, while 51
Short-term safety impact on the patient (up to one year) did for a total of 2649 patients. However, 10 of the listed
was limited: no prosthesis removal/revisions were report- publications (272 patients) were limited to infection cases
ed. All complications reported were neurological neuropa- and their bacterial specifics only and were excluded from

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LEANDRO TMJ RECONSTRUCTION WITH CUSTOM PROSTHESIS

overall safety risk estimation, leaving safety data on a the preoperative situation, indicating significant improve-
total of 2377 patients. None of the adverse events has a ment in oral health and quality of life. A decrease in pain
consolidated frequency of more than 5%. The most com- values and OHIP 14 questionnaire score after 12 months of
mon complications were a temporal weakness of the facial follow-up. This coincides with restoration in mouth open-
nerve (incidences ranging from 2-58%) and wound infec- ing and improving eating ability, resulting in high patient
tion with revision/prosthesis removal (incidences ranging satisfaction (Figure 1, 2). The positive impact on patient
from 0.5-8%). However, the frequencies of adverse events outcomes is comparable to those described for similar TMJ
reported in the different separate studies showed large prostheses.14 performed a systematic review and meta-
variation and could reach up to 100% in small case series. analysis on patient outcomes after TMJ arthroplasty with
This could be explained by the large variation in study de- TMJ concept, Biomet (Biomet, Inc., Warsaw, IN, USA) or
sign (case studies, retrospective, or prospective case-se- Nexus (Cottonwood Heights, UT, USA) prostheses. The
ries) and different methodologies in safety data collection. improving pain/satisfaction scores and mouth opening res-
The type of complications reported in this study is com- toration are similar to those similar TMJ prostheses (Table
parable to the state-of-the-art, with no new adverse events V). No significant improvement in MIO was observed for
not reported so far. Temporary peripheral nerve palsies and the Materialise prosthesis due to the significant variation
paresthesia were the most reported events in a subset of in preoperative MIO (Table IV; Figure 1), which was also
patients (N.=9/9 and 7/9 respectively), collected by one observed in the studies included in the review of Johnson
investigator. Also, edemas were reported in 8/9 patients or et al.14 The postoperative MIO in this study is in line with
at 11/14 prosthesis sides, which relates to the swellings those measured with similar prostheses (Table V).
reported in 2 studies (3/94 patients) in the state-of-the-art.
There is no removal or revision of any prostheses, and no Limitations of the study
infections or other complications were reported in this The study has several limitations. Firstly, it is limited by
study. Also, in the state-of-the-art, the infection rate is low its design. Due to the retrospective nature of data collec-
(2%, range 0.5-8%, leading to a revision of the prosthesis tion, missing data could not be retrieved, leading to an in-
in 1.7%, range 0.5-8%, of the patients). Incidence rates of complete dataset and a lower number of patients for each
these complications in this study are high compared to the follow-up time point and lowering the power of the sta-
state-of-the-art. A head-to-head comparison with state-of- tistical analyses. Secondly, the limited patient follow-up
the-art is difficult due to the low number of patients includ- only allows for short-term conclusions on the use of this
ed in this study. Detailed safety information was only col- TMJ prosthesis. No conclusions could be drawn on the
lected by one surgeon in a subset of 9 patients. Secondly, long-term safety and performance. However, the collected
a large degree of variation in study designs and safety re- patient outcome parameters stabilize after 3 to 6 months,
porting methodology was detected in the state-of-the-art. rendering the 1Y follow-up time sufficient for a proper pa-
The investigators judged all reported events related to the tient benefit conclusion.
surgical procedure and not directly to the prosthesis. All
events resolved after treatment. In conclusion, the short- Conclusions
term safety risk of the TMJ prosthesis can be considered
low. The TMJ arthroplasty with the Engimplan/Materi- Future research is needed to address the long-term safety
alise Company prosthesis has a positive impact on patient and performance of this TMJ prosthesis. Firstly, this ret-
health and satisfaction. All collected clinical outcomes rospective study can be extended to include additional pa-
were restored or even significantly improved compared to tients treated by the participating surgeons and add more

Table V.—Weighted mean difference between postop vs. preop scores for pain, diet, MIO, and weighted mean postop MIO (last postop
timepoint available) for different TMJ implant brands based on systematic literature review.
Concept Biomet Nexus Materialise
N. Mean 95% CI N. Mean 95% CI N. Mean 95% CI N. Mean SD
Pain difference (VAS) 274 -5.16 -6.43; -3.90 601 -3.21 -6.03; -0.40 102 -5.05 -5.87; -4.24 21 -5.9 2.5
Diet difference (VAS) 225 -4.26 -6.06; -2.45 624 -5.51 -6.70; -4.31 NA 21 -3.4 2.5
MIO difference (cm) 242 8.99 5.45; 12.54 601 24.88 2.91; 46.85 102 9.50 5.86; 13.14 17 5.1 11.1
MIO postop (cm) 242 34.55 33.29; 35.81 601 38.33 28.29; 48.37 102 27.57 24.02; 31.13 17 36.6 3.0
CI: confidence interval; MIO: maximum interincisal opening; N.: number of patients included in the measure; SD: standard deviation. VAS: Visual Analogue Scale.

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TMJ RECONSTRUCTION WITH CUSTOM PROSTHESIS LEANDRO

long-term follow-up time points. Additionally, more data 5. Wolford LM, Cottrell DA, Henry CH. Temporomandibular joint re-
construction of the complex patient with the Techmedica custom-made
on the preoperative medical situation (comorbidities, the total joint prosthesis. J Oral Maxillofac Surg 1994;52:2–10, discussion 11.
reason for previous revisions) of the patients would help 6. Abramowicz S, Dolwick MF, Lewis SB, Dolce C. Temporomandibular
to interpret the results. Secondly, a prospective long-term joint reconstruction after failed teflon-proplast implant: case report and
literature review. Int J Oral Maxillofac Surg 2008;37:763–7.
follow-up study (PMCF) would add more high-quality
7. Brenol CV, Monticielo OA, Xavier RM, Brenol JC. [Rheumatoid ar-
clinical evidence with a complete dataset, allowing a high- thritis and atherosclerosis]. Rev Assoc Med Bras 2007;53:465–70. [Por-
power statistical comparison with preoperative values or tuguese]
data from the literature. 8. Fricton JR, Look JO, Schiffman E, Swift J. Long-term study of tem-
poromandibular joint surgery with alloplastic implants compared with
nonimplant surgery and nonsurgical rehabilitation for painful temporo-
mandibular joint disc displacement. J Oral Maxillofac Surg 2002;60:1400–
11, discussion 1411–2.
References
9. Bai G, He D, Yang C, Chen M, Yuan J, Wilson JJ. Application of digital
templates to guide total alloplastic joint replacement surgery with biomet
1. Capote A, Rodríguez-Campo FJ, Escorial V, Muñoz-Guerra M, Gil- standard replacement system. J Oral Maxillofac Surg 2014;72:2440–52.
Diez JL. 022 Total temporomandibular joint (TMJ) reconstruction with
alloplastic prosthesis. Review of our experience. J Craniomaxillofac Surg 10. Hu Y, Zhang L, He D, Yang C, Chen M, Zhang S, et al. Simultaneous
2006;34:6. treatment of temporomandibular joint ankylosis with severe mandibular
deficiency by standard TMJ prosthesis. Sci Rep 2017;7:45271.
2. da Cunha SC, Nogueira RV, Duarte ÂP. Vasconcelos BC do E, Almeida
R de AC. Análise dos índices de Helkimo e craniomandibular para diag- 11. Moreira CV, Serra AV, Silva LO, Fernandes AC, de Azevedo RA. To-
nóstico de desordens temporomandibulares em pacientes com artrite reu- tal bilateral TMJ reconstruction for pain and dysfunction: case report. Int
matóide. Rev Bras Otorrinolaringol 2007;73:19. J Surg Case Rep 2018;42:138–44.
3. McLeod NM, Saeed NR, Hensher R. Internal derangement of the 12. Slade GD, Spencer AJ. Development and evaluation of the Oral
temporomandibular joint treated by discectomy and hemi-arthroplasty Health Impact Profile. Community Dent Health 1994;11:3–11.
with a Christensen fossa-eminence prosthesis. Br J Oral Maxillofac Surg 13. Slade GD. Derivation and validation of a short-form oral health im-
2001;39:63–6. pact profile. Community Dent Oral Epidemiol 1997;25:284–90.
4. Ko EW, Huang CS, Chen YR. Temporomandibular joint reconstruc- 14. Johnson NR, Roberts MJ, Doi SA, Batstone MD. Total temporoman-
tion in children using costochondral grafts. J Oral Maxillofac Surg dibular joint replacement prostheses: a systematic review and bias-adjust-
1999;57:789–98, discussion 799–800. ed meta-analysis. Int J Oral Maxillofac Implants 2017;46:86–92.

Conflicts of interest.—The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.
Authors’ contributions.—All authors equally contributed to the study conception and design, and to the data acquisition; Ariane Lopes, Wouter Houthoofd and
Fernando M. Ornellas have given substantial contributions to the data analysis; Luiz F. Leandro, Guilherme Omizzolo, Ariane Lopes, Wouter Houthoofd and
Fernando M. Ornellas contributed to the manuscript draft; all authors revised it critically. All authors read and approved the final version of the manuscript.
Acknowledgements.—The authors acknowledge all those who participated in the work, all the doctors, especially the ones who brilliantly assisted in col-
lecting data and the writing of this manuscript. The authors also acknowledge Engimplan/Materialise, for all support in the manufacture of customized
prostheses and the attention dedicated to this work, particularly Silvia Botelho and Thiago Torres Walder (Engimplan) for their local study coordination and
Valeria Prystopiuk (Materialise) for the planning and execution of the systematic literature research. Finally, the authors acknowledge Dr. Ornellas, for the
availability of the data obtained.
History.—Manuscript accepted: September 1, 2022. - Manuscript received: July 5, 2022.

Vol. 6 - No. 3 European Journal of Oral and Maxillofacial Surgery 127