Beruflich Dokumente
Kultur Dokumente
12547
Abstract
Aim: This study evaluates a porcine collagen matrix (CM) for soft tissue thicken-
ing in comparison to the subepithelial connective tissue graft (SCTG).
Material and Methods: In eight beagle dogs, soft tissue thickening was performed
at the buccal aspects of the upper canines (SCTG and CM). Impressions were
taken before augmentation (i1), after surgery (i2), after one (i3), three (i4) and ten
month (i5). Casts were optically scanned with a 3D scanner and each augmented
region (unit of analysis) evaluated (primary outcome variable: volume increase in
mm3; secondary outcome variables: volume increase in percent, mean and maxi-
mum thickness increases in mm).
Results: 3D tissue measurements after surgery revealed a significant higher vol-
ume increase in the CM (86.37 mm3 35.16 mm3) than in the SCTG group Key words: CAD CAM; collagen matrix;
(47.65 mm3 17.90 mm3). After 10 months, volume increase was non-significant collagen-based matrix; dental implants;
between groups (SCTG:11.36 mm3 9.26 mm3; CM: 8.67 mm3 13.67 mm3). gingiva thickening; gingival biotype;
mucodermâ; porcine collagen matrix; soft
Maximum soft tissue thickness increase (i1-i5) was 0.66 mm 0.29 mm (SCTG)
tissue augmentation; soft tissue volume;
and 0.79 mm 0.37 mm (CM) with no significant difference. subepithelial connective tissue graft;
Conclusions: Ten months after soft tissue thickening, the CM is statistically non- volumetric measurement
inferior to the SCTG in terms of soft tissue volume and thickness increase.
Further 3D studies are needed to confirm the data. Accepted for publication 11 March 2016
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd 609
610 Schmitt et al.
Soft tissue volume augmentation et al. 2014, Akcali et al. 2015). The a of 0.05 when the means are truly
procedures have been proposed to usage of collagen matrices as alter- equivalent. Gingival thickness
surgically correct localized alveolar native cannot be recommended at increase was assumed to be
defects as pre-prosthetic site develop- this time point due to the lacking 1.00 mm 0.3 mm and the equiva-
ment or ridge preservation proce- evidence about the volume loss that lence margin was set to be 0.5 mm.
dures, and have been used for soft occurs during integration and degra- The study was approved by the
tissue contouring around implants dation and the uncertainty of the Pest county government department
(Studer et al. 2000, Jung et al. 2004, volumetric long-term stability of for food safety and animal health,
Schneider et al. 2011, Vignoletti augmented soft tissues (Thoma et al. Hungary, number 54-2532.1-45/12.
et al. 2014, Akcali et al. 2015). 2014). The manuscript was prepared in
Subepithelial connective tissue grafts The aim of this study was to test accordance to the Animal Research:
(SCTG) are currently the gold stan- whether or not soft tissue augmenta- Reporting In Vivo Experiments
dard of care for soft tissue volume tion with a native porcine CM leads (ARRIVE) Guidelines Checklist
augmentation procedures (Sanz & to a soft tissue volume and thickness (Kilkenny et al. 2010).
Simion 2014, Thoma et al. 2014, increase around teeth similar to out-
Zuhr et al. 2014). comes obtained by the SCTG. The Outcome variables
As alternative to SCTGs, xeno- soft tissue volume augmentation was
Primary outcome variable
geneic soft tissue substitutes such as simulated by thickening attached
porcine-derived 3D collagen-based peridental soft tissues in a pre-clini- The primary outcome variable was
matrices are currently in the focus, cal dog model including a clinical the Integrated Distance (volume
with the intention to avoid postoper- three-dimensional and morphologic increase in mm3) in the region of
ative patient morbidities and risks follow-up of 10 months. This partic- interest (ROI).
associated with autologous tissue ular model was chosen to eliminate
Secondary outcome variables
grafting (Sanz et al. 2009, Ghanaati tissue changes of the surrounding
et al. 2011, Schmitt et al. 2013, hard and/or soft tissues, that may The secondary outcome variables
Nocini et al. 2014). Originally, such have be arisen in terms of edentulous were the Integrated Distance in %
collagen matrices were introduced to ridges (Thoma et al. 2010, 2011), the (postoperative Integrated Distance
promote keratinized tissue regenera- presence of dental implants or gingi- defined as 100%), the Maximum
tion and in the further course subse- val recessions around teeth. It is Distance (mm) and the Mean Dis-
quently used for root coverage hypothesized, that volumetric tissue tance (mm) in the ROI.
procedures (Sanz et al. 2009, Her- changes are solely attributed to the The Maximum Distance describes
ford et al. 2010, McGuire & Scheyer soft tissue augmentation procedure the maximum deviation (mm) of the
2010, Nevins et al. 2011, Zuhr et al. and will not be masked by further surface comparison of two objects.
2014). Due to its potential to influencing factors. The Mean Distance describes the
increase the gingival thickness in arithmetic mean deviation (mm) of
terms of recession coverage, further all points of the surface comparison
Material and Methods
research focused on its use as SCTG of two objects.
substitute for soft tissue volume aug-
Study design
mentations (Thoma et al. 2010, Sedation, anaesthesia and animal care
2011). To our knowledge the study The present paper reports on a pre-
of Thoma et al. (2010) is currently clinical animal study with a follow- Eight healthy female beagle dogs, at
the only study that has examined up of 10 months (May 2014–January the age of at least 12–18 months,
volume alterations after soft tissue 2015) including eight healthy beagle were selected by a veterinarian prior
augmentation with a 3D collagen dogs in a split-mouth design. The to study start from a local animal
matrix (CM) compared to the SCTG aim of the current research was to breeder. After a 1-month period of
with a three-dimensional measuring evaluate the natural porcine 3D col- acclimatization animals were exam-
method (Thoma et al. 2010). Volu- lagen matrix (CM, mucodermÒ, ined and judged as healthy by the
metric outcomes revealed statistically botiss biomaterials GmbH, Zossen, veterinarian and included in the
non-significant thickness and volume Germany) for soft tissue thickening study. Prior to the study start all
increases in the augmented regions in a dog model and compare it to animals received a transponder
after 84 days, indicating that the the current gold standard of care, (AlvicÒ complete Alvetra GmbH,
CM might be suitable as alternative the SCTG. Each animal received an Neum€ unster, Germany) to guarantee
to the SCTG to augment localized autologous SCTG (control group) a clear allocation of the animals to
alveolar ridge defects (Thoma et al. from the palate and a CM (test the experimental protocol. All surg-
2010). Long-term volumetric pre- group) in a randomized split-mouth eries were performed under general
clinical and clinical data with the use allocation. The sample size consider- anaesthesia. Pre-treatment sedation
of 3D collagen matrices for soft tis- ation was based on the increase in (midazolam 0.05–0.1 mg/kg and
sue thickening does not exist in the the gingival thickness (mm) after ketanest 1–2 mg/kg intramuscularly)
literature. 10 months. An equivalence test of was given 10–15 min. prior to
Therefore, in clinical practice, means using two groups of eight administration of the general anaes-
autologous tissues are mainly used augmented sites (total 16 augmented thesia. The animals were anaes-
for soft tissue volume augmentations sites, eight animals) achieved a thetized with thiopental sodium
today (Thoma et al. 2014, Zuhr power of 0.91 at a significance level (20 mg/kg body weight). Inhalation
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Porcine CM versus SCTG for gingiva augmentation 611
was performed with oxygen, nitrous of the buccal soft tissues tunnelled in sion was made from P1 to P4 and a
oxide and isoflurane (1.5–2.0% a mesiodistal direction with a split- subepithelial split-flap sharply dis-
isoflurane in 2 l/min. flow of oxy- flap. The resulting tunnel was either sected towards the midline of the
gen). After surgery animals received augmented with a SCTG from the palate. The SCTG was harvested
post-surgical antibiotics (Strepto- palate or the CM (after rehydrating with the periosteum and the wound
mycin 0.5 g/day, Gr€unenthal GmbH, with sterile saline solution) (Fig. 1). bed immediately treated with local
Stolberg, Germany) for 3 days. The graft size was standardized: haemostatic measures such as elec-
Immediately after surgery animals 20 mmx 10 mmx 1.2–1.7 mm in the trocoagulation and suturing with
were monitored and kept warm until CM group prior rehydrating (thick- resorbable sutures (Vicryl 5.0, Ethi-
full recovery. Post-surgical care ness ranging from 1.2 to 1.7 mm as con GmbH & Co KG, Norderstedt,
included daily observations docu- it is commercially available) and Germany).
menting any adverse events, i.e. 20mmx 10mmx 1.5–2 mm in the After surgery, an additional
bleedings, pain, swelling, discomfort SCTG group. The mesial vertical impression (i2) was taken in the
and appetite. incision was sutured with resorbable ROI. Follow-up measures were per-
At each of the further investiga- sutures (Vicryl 5.0, Ethicon GmbH formed 1, 3 and 10 months after sur-
tion time points (one, three and & Co KG, Norderstedt, Germany). gery. The augmented region was
10 months) animals were sedated The SCTG was harvested from clinically examined detecting any
with midazolam 0.05–0.1 mg/kg and the palate. After local anaesthesia of kind of wound healing complica-
ketanest 1–2 mg/kg intramuscularly. the palate in the region of the tions. At all the time points, impres-
canine, mandibular premolars (P1– sions (i3, 1 month; i4, 3 months and
Surgical procedure and follow-up
P4) and the first molar, a para- i5, 10 months) were taken as previ-
marginal palatal subepithelial inci- ously described.
Impressions and assessments prior
surgeries as well as the surgeries
were performed by the first and the
last author (CMS: surgeon, KAS:
surgical assistance). Follow-up treat-
ments and measurements were per-
formed by the co-authors (blinded
examiners). Surgeons and examiners
were calibrated prior start of the
corresponding procedure.
After general anaesthesia an
impression (i1) was taken with a
polyether impression material
A B
(ImpregumTM PentaTM Polyether
Impression Material, 3M Deutsch-
land GmbH, Neuss, Germany) and a
prefabricated impression tray.
Soft tissue thickness of the kera-
tinized mucosa was clinically mea-
sured with the bone mapping
method (transgingival probing of
gingival thickness) at the buccal
aspect of each canine (Wilson 1989).
This was standardized performed C D
2 mm below the most coronal extend
of the keratinized mucosa and 2 mm
coronal to the mucogingival junction
in the central longitudinal axis of the
canine with a thin gauge. Measure-
ments in whole millimetres were
recorded. Each of the two treatments
(CM and SCTG) were then ran-
domly assigned to either the right or
left upper canine by simple random-
ization flipping a coin. After local E F
anaesthesia (UltracainÒ DS forte;
Fig. 1. Exemplary pictures of the augmentation procedure with the use the collagen
adrenaline 1:100,000; Sanofi-Aventis matrix (CM) for peridental soft tissue thickening in the region of the upper canine.
GmbH, Frankfurt, Germany) at the After a mesial submucosal vertical incision, the soft tissues were tunnelled in a distal
buccal aspect of the canine, a mesial direction with a microsurgical blade (A and B), the CM inserted (C) and the wound
vertical subepithelial incision was sutured with resorbable sutures (D). (E) showing the clinical situation of a grafted site
performed and the keratinized part with the use of the CM after 1 month and (F) after 10 months.
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
612 Schmitt et al.
Three-dimensional measurements
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Porcine CM versus SCTG for gingiva augmentation 613
Table 1. Showing the outcomes of the three-dimensional analyses for the control (subepithelial connective tissue graft; SCTG) and the test
group (collagen matrix; CM). Mean, median and standard deviation (SD) is given for each parameter
Outcomes of three-dimensional measurements comparing the situation directly after surgery (i2),
1 month after surgery (i3), 3 month after surgery (i4) and 10 month after surgery (i5) with the
situation prior surgery (i1)
SCTG Integrated Distance (mm3) 47.65 48.61 17.90 25.12 21.16 23.36 7.64 6.60 8.56 11.36 13.03 9.26
Integrated Distance % 100.00 100.00 .00 45.27 44.06 32.06 28.40 21.10 36.49 27.08 29.74 18.75
Maximum Distance (mm) 1.57 1.54 0.28 1.05 0.91 0.48 0.70 0.67 0.42 0.66 0.67 0.29
Mean Distance (mm) 0.65 0.56 0.26 0.37 0.24 0.37 0.05 0.05 0.25 0.13 0.19 0.26
CM Integrated Distance (mm3) 86.37 90.32 35.16 15.15 12.38 13.83 5.57 1.93 7.79 8.67 0.74 13.67
Integrated Distance % 100.00 100.00 0.00 16.99 12.82 13.98 9.47 2.68 11.80 11.33 0.57 17.10
Maximum Distance (mm) 2.00 2.01 0.22 1.12 0.90 0.91 0.65 0.60 0.47 0.79 0.88 0.37
Mean Distance (mm) 0.96 0.98 0.22 0.20 0.18 0.19 0.04 0.02 0.14 0.01 0.01 0.26
directly after soft tissue thickening mean Integrated Distance of 5.57 mm3 7.79 mm3 (CM). Intra-
(i1-i2) (Table 1, Figs 3, 5 and 6). 25.12 mm3 23.36 mm3 in the group comparisons revealed a statis-
Further inter-group comparisons SCTG group and 15.15 mm3 tically significant decrease between
were statistically non-significant at 13.83 mm3 in the CM group after the 1 month (i1-i3) and the 3 months
all investigation time points and for 1 month (i1-i3) with a statistically (i1-i4) evaluation time points in both
all measured parameters (Table 1, significant decrease in both groups groups (SCTG: p = 0.043; CM:
Figs 3–6). The mean Integrated Dis- (intra-group comparisons of i1-i2 0.043) (Fig. 3). After 10 months (i1-
tance (augmented tissue volume; with i1-i3, SCTG: p = 0.018; CM: i5) the mean Integrated Distance was
mm3 and %) and the mean Maxi- 0.012). From the first (i1-i3) to the 11.36 mm3 9.26 mm3 in the SCTG
mum and mean Mean Distances third month (i1-i4), the soft tissue and 8.67 mm3 13.67 mm3 in the
(mm) decreased in both groups over decrease was lower and afterwards CM group. Maximum soft tissue
time. The highest volume and thick- relatively stable up to 10 months (i1- thickness increase after 10 months
ness decrease occurred in the early i5). The mean Integrated Distances (i1-i5) was 0.66 mm 0.29 mm
phase of healing (first month follow- after 3 months (i1-i4) were (SCTG) and 0.79 mm 0.37 mm
ing surgery, i1-i3). This resulted in a 7.64 mm3 8.56 mm3 (SCTG) and (CM) with no significant inter-group
difference (i1-i5).
Discussion
This study aimed to evaluate a por-
cine CM for soft tissue thickening in
a dog model. With a three-dimen-
sional measuring method, the vol-
ume and thickness alterations of the
augmented soft tissues could be mea-
sured and directly compared to the
soft tissues augmented with the
autologous SCTG. The volume gain,
achieved directly after surgery, was
significantly higher (86.37 mm3
35.16 mm3) in the CM group than in
the SCTG group (47.65 mm3
17.90 mm3). This was also reflected
in the thickness of the grafted soft
tissues with a mean maximum thick-
ness increase of 2.00 mm 0.22 mm
for the CM and 1.57 mm
0.28 mm for the SCTG (significant
difference p = 0.005). The integra-
tion of both grafts was associated
Fig. 3. Showing the primary outcome of the study, the mean Integrated Distance with a high degree of shrinkage
(mm3) in the augmented region over time for the test (CM) and control group (especially in the first month). After
(SCTG). Statistical significant differences are given for inter- and intra-group compar- 3 months, soft tissue dimensions
isons (p < 0.05). were stable in both groups, resulting
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
614 Schmitt et al.
the total tissue thickness increases The accuracy of the method is highly Ghanaati, S., Schlee, M., Webber, M. J., Willer-
shausen, I., Barbeck, M., Balic, E., Gorlach,
measured in our study were solely influenced by the accuracy of the
C., Stupp, S. I., Sader, R. A. & Kirkpatrick, C.
attributed to the soft tissue volume impressions and the casts. Further J. (2011) Evaluation of the tissue reaction to a
increase achieved by the soft tissue three-dimensional scanning systems new bilayered collagen matrix in vivo and its
thickening procedure. This knowl- will probably eliminate the need for translation to the clinic. Biomedical Materials
edge can be helpful in clinical prac- impressions by an intra-oral in vivo 6, 015010.
Herford, A. S., Akin, L., Cicciu, M., Maiorana,
tice, and make outcomes of soft scan. C. & Boyne, P. J. (2010) Use of a porcine col-
tissue thickening procedures more Since it is not entirely clarified lagen matrix as an alternative to autogenous
predictable. until today, what happens exactly by tissue for grafting oral soft tissue defects. Jour-
Some limitations exist with the integration of the free SCTG nal of Oral and Maxillofacial Surgery 68, 1463–
1470.
respect to the present animal study. and collagen based matrices, further Jepsen, K., Jepsen, S., Zucchelli, G., Stefanini,
First of all, a relatively small number research should keep on focusing on M., de Sanctis, M., Baldini, N., Greven, B.,
of animals were treated. This may the integration and degradation pro- Heinz, B., Wennstrom, J., Cassel, B., Vigno-
have influenced the outcome of the cess of used grafts and investigate letti, F. & Sanz, M. (2013) Treatment of gingi-
val recession defects with a coronally advanced
statistical comparisons between the the biological processes that might flap and a xenogeneic collagen matrix: a multi-
groups. In addition, the used grafts lead to volume increase or decrease center randomized clinical trial. Journal of Clin-
(SCTG and the CM) were not of the in the course of healing. ical Periodontology 40, 82–89.
same size after rehydrating the CM, Jung, R. E., Siegenthaler, D. W. & Hammerle, C.
H. (2004) Postextraction tissue management: a
leading to significant greater graft
Conclusion soft tissue punch technique. International Jour-
volumes and thicknesses in the CM nal of Periodontics & Restorative Dentistry 24,
group directly after surgery. Rehy- Within the limitations of the study, 545–553.
drating the CM obviously leads to a outcomes indicate that the porcine Kilkenny, C., Browne, W., Cuthill, I. C., Emer-
minimal increase in volume. In this CM used in this study is statistically son, M., Altman, D. G. & NC3Rs Reporting
Guidelines Working Group. (2010) Animal
study, one should have trimmed the non-inferior after 10 months for the research: reporting in vivo experiments: the
CM after the rehydration process volume augmentation of the kera- ARRIVE guidelines. British Journal of Pharma-
avoiding this shortcoming. However, tinized gingiva than the gold stan- cology 160, 1577–1579.
expressing the augmented volume in dard of care, the SCTG. Graft McGuire, M. K. & Scheyer, E. T. (2010) Xeno-
geneic collagen matrix with coronally advanced
percent eliminated the difference shrinkage, which seems to be associ- flap compared to connective tissue with coro-
between the groups concerning the ated with the healing process after nally advanced flap for the treatment of dehis-
absolute augmented volume and a soft tissue grafting needs to be con- cence-type recession defects. Journal of
comparison could be performed. sidered in clinical practice. With the Periodontology 81, 1108–1117.
Molnar, B., Aroca, S., Keglevich, T., Gera, I.,
Another limitation of this study knowledge of the properties of the Windisch, P., Stavropoulos, A. & Sculean, A.
is that we did not create a real clini- CM, practitioners should consider its (2013) Treatment of multiple adjacent Miller
cal treatment scenario and the treat- clinical use indication-dependent. Class I and II gingival recessions with collagen
ment applied in this study is not Still, further research in a variety of matrix and the modified coronally advanced
tunnel technique. Quintessence International 44,
directly transferable to the clinical animal models and clinical trials is
17–24.
practice. Outcomes of this study will needed to confirm the outcomes of Nevins, M., Nevins, M. L., Kim, S. W., Schup-
certainly contribute to better charac- this study and make treatment out- bach, P. & Kim, D. M. (2011) The use of
terize the used CM and judge its comes more predictable. mucograft collagen matrix to augment the zone
potential for soft tissue thickening. of keratinized tissue around teeth: a pilot
study. International Journal of Periodontics &
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Clinical Relevance Principal findings: Soft tissue thick- Practical implications: With suffi-
Scientific rationale for the study: ening around teeth resulted in a cient integration and augmentation
To evaluate the potential of a non-significant soft tissue volume properties, the tested collagen
native collagen matrix (CM) for and thickness increase in both matrix could serve as an alternative
soft tissue thickening (simulated groups after 10 months. The healing to the SCTG for soft tissue thick-
around teeth in a dog model) as after soft tissue volume augmenta- ening. Further clinical research
alternative to the autologous tion goes along with a large volume should focus on its regeneration
subepithelial connective tissue graft loss in the early healing phase (first potential in specific treatment sce-
(SCTG). month). narios.
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd