RESEARCH Open Access
Single oo h es o a ion in he maxilla y
es he ic zone using a one-piece ce amic
implan wi h 1 yea o ollow-up: case
se ies
Mi en Vilo -Fe nández
1
, Ana-Ma ía Ga cía-De-La-Fuen e
1*
, Xabie Ma ichala -Mendia
2
, Ru h Es e anía-F esco
1
and
Luis-An onio Agui e-Zo zano
1
Abs ac
Backg ound: O al implan s ha e helped clinicians o imp o e he quali y o li e o many pa ien s. The ma e ial o
choice o den al implan s cu en ly emains i anium ype IV, whose mechanical and biological p ope ies ha e
been p o en h oughou he his o y o implan ology. Ye , his ma e ial is no exemp om complica ions. Fo hese
easons, ce amic al e na i es o i anium ha e eme ged. Thus, he pu pose o his s udy is o e alua e pe i-implan
ha d and so issue s abili y wi h he use o a one-piece ce amic implan (S aumann® PURE Ce amic Implan )
du ing 1 yea o ollow-up.
S udy design: One-piece all-ce amic zi conia (Z O
2
) implan s we e placed o eplace single missing ee h in he
es he ic zone. Six o 8 weeks a e he p ocedu e, he de ini i e p os hesis was ab ica ed. A he ime o p os hesis,
placemen (T
0
) pho og aphs and pe iapical adiog aphs we e aken, and he ollowing clinical pa ame e s we e
eco ded: p obing dep h (PD), plaque index (PI), bleeding on p obing (BOP), suppu a ion on p obing (SOP), dis ance
om gingi al ma gin o incisal edge (GM-IE), and Jem papilla index (JPI). Follow-up appoin men s we e scheduled
a 4 (T
4
), 8 (T
8
), and 12 (T
12
) mon hs, when he same pa ame e s we e eco ded. In addi ion, plaque con ol was
ein o ced and p ophylaxis was ca ied ou . In his las appoin men , a inal pe iapical adiog aph was aken o
assess ma ginal bone loss.
Resul s: A o al o 32 zi conia implan s we e placed in 28 pa ien s (16 women and 12 men, aged be ween 34 and
67 yea s). The su i al and success a e we e 96.9%. The inc ease in p obing dep h om baseline o 12 mon hs was
0.78 mm. Assessmen s o plaque index and bleeding on p obing showed a sligh inc ease h oughou he s udy.
Conclusions: The esul s ob ained wi h he S aumann® PURE Ce amic implan s show hem o exhibi e y good
clinical beha io . The su i al a e o he implan s o ou pilo s udy was 96.9%. Fo hese easons, we can say ha
zi conia implan s could be an al e na i e o i anium implan s in he es he ic zone.
Keywo ds: Zi conia implan , Ce amic implan , One-piece, Single oo h, Ma ginal bone loss, Su i al a e
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* Co espondence: anama ia[email p o ec ed]
1
Depa men o S oma ology II, Uni e si y o he Basque Coun y (UPV/EHU),
Ba io Sa iena s/n, 48940 Leioa, Bizkaia, Spain
Full lis o au ho in o ma ion is a ailable a he end o he a icle
In e na ional Jou nal o
Implan Den is y
Vilo -Fe nández e al. In e na ional Jou nal o Implan Den is y (2021) 7:26
h ps://doi.o g/10.1186/s40729-021-00308-z
Backg ound
O al implan s ha e helped clinicians o imp o e he
quali y o li e o many pa ien s. The ma e ial o choice
o den al implan s cu en ly emains i anium ype IV,
whose mechanical and biological p ope ies ha e been
p o en h oughou he his o y o implan ology [1,2].
Ye , his ma e ial is no exemp om complica ions.
Fi s , his ype o me allic implan can ha e es he ic limi-
a ions, especially when used in an e io egions and in
pa ien s wi h a hin bio ype. The complica ions o which
we e e a e he appea ance o a me allic ma gin due o
ecession, o g ayish colo a ions due o he anslucency
o he me al h ough he pe i-implan mucosa [3–5].
Second, some s udies ha e epo ed immunological eac-
ions o i anium pa icles which lead o biological com-
plica ions [6,7], while o he s ha e demons a ed alle gic
eac ions o i anium, including Sicilia e al. (2008) who
obse ed a p e alence o 0.6% [8,9]. Finally, i mus also
be aken in o accoun ha he numbe o pa ien s who
demand “me al- ee”implan s is inc easing.
Fo hese easons, ce amic al e na i es o i anium
ha e eme ged. The i s ce amic implan s a i ed on he
ma ke mo e han 40 yea s ago. They we e made o alu-
mina, a ma e ial p one o ac u e when loaded un a o -
ably [10], and so, hey a e no longe a ailable. Cu en ly,
he ma e ial o choice o he manu ac u e o ce amic
implan s is y ia e agonal zi conia polyc ys al (Y-
TZP), cha ac e ized by i s high esis ance o ac u e, a
low modulus o elas ici y, a low a ini y o plaque and
high biocompa ibili y [11–14].
The objec i e o his pilo s udy was o e alua e he
s abili y o ha d and so pe i-implan issues wi h he
use o a one-piece ce amic implan (S aumann® PURE
Ce amic Implan Mono ype) wi h a 1-yea ollow-up.
Ma e ials and me hods
S udy design
This p ojec began, ini ially, as a pilo s udy, which con-
sis s o a e ospec i e pa and a p ospec i e ollow-up
pa . This obse a ional ambispec i e clinical s udy was
app o ed by he Clinical Resea ch E hics Commi ee o
he Basque Coun y (CEIC-E) (In e nal Code PI2016088,
07/2016). In addi ion, i is egis e ed a www.Clinical-
T ials.com (n° NCT03352284).
S udy popula ion
Pa ien s who me he ollowing inclusion c i e ia we e
included in he s udy:
1. Pa ien s ea ed in Own Mas e o Pe iodon ology
and Osseoin eg a ion in he Uni e si y o he
Basque Coun y (UPV/EHU)
2. Age > 18 yea s
3. One single oo h missing in he an e io maxilla
(1.5–2.5)
4. Plaque index <20% [15]
5. Bleeding on p obing index <20% [16]
6. Pe iodon ally heal hy o ea ed pe iodon al
condi ions
7. Is able o ully unde s and he na u e o he
p oposed su ge y and is able o p o ide signed
in o med consen
Con e sely, pa ien s who p esen ed any o he ollow-
ing exclusion c i e ia we e no included in he s udy:
1. Gene al con aindica ions o den al and/o su gical
ea men
2. Is aking medica ions o ecei ing ea men s which
ha e an e ec on healing in gene al (e.g., s e oids o
la ge doses o an i-in lamma o y d ugs)
3. Un ea ed pe iodon al condi ions
4. No willing o pa icipa e
In his way, a o al o 28 pa ien s (16 women and 12
men) wi h a mean age o 54.1 yea s [34-67 yea s] who
equi ed den al implan s o eplace a single oo h in he
maxilla we e ec ui ed o pa icipa e in he s udy, and all
o hem we e p ope ly in o med and signed a w i en in-
o med consen .
Clinical and adiog aphic e alua ion
All-ce amic one-piece implan s (PURE Ce amic Im-
plan s Mono ype, Ins i u S aumann AG, Basel,
Swi ze land) we e used.
Be o e su ge y, a clinical and adiog aphic diagnos ic
assessmen was ca ied ou o choose he app op ia e
implan o each case. To loca e he 3D implan posi ion,
he ollowing minimal dis ances we e aken in o consid-
e a ion: minimum 1.5 o 2 mm om he na u al adja-
cen ee h, 1 mm pala al o he ideal poin o eme gence,
and 2 mm apical o he mid acial gingi al ma gin o he
inal implan p os hesis [17]. A minimum o 1.5 mm o
2 mm hickness o buccal bone was p ese ed as well.
The implan diame e and he leng h we e chosen ac-
co ding o each indi idual case. These implan s had wo
di e en abu men heigh s: 4 and 5.5 mm, and o he
selec ion o he implan , all hese conside a ions (pos-
i ion o na u al ee h, wid h o al eola idge and occlu-
sion) we e aken in o conside a ion in he plani ica ion
o he ea men o each pa ien . Finally, s udy models
we e made o manu ac u e splin s o use as su gical
guides o each pa ien .
All su ge ies we e pe o med unde local anes hesia
wi h a icaine (Meganes ® 1:200.000, Cla ben, Mad id,
Spain). The su gical echnique consis ed in he ele a ion
o a ull- hickness mucope ios eal lap, bo h es ibula
Vilo -Fe nández e al. In e na ional Jou nal o Implan Den is y (2021) 7:26 Page 2 o 8
and pala al, h ough a mid-c es al incision. A e he al-
eola bone had been exposed, he d illing sequence was
ca ied ou acco ding o he manu ac u e ’s ins uc ions
be o e he placemen o he ix u e. In some cases whe e
bone olume was insu icien , dehiscence o enes a-
ions we e ea ed by he guided bone egene a ion ech-
nique wi h xenog a (Bio-Oss®, Geis lich Pha ma AG,
Wolhusen, Swi ze land) and eso bable collagen mem-
b ane (Collagene AT®, Cen o de Odon oia ia Ope a i a
S.R.L, Podo a, I aly). Once he implan had been
inse ed, a healing cap was placed in almos all cases and
he lap was closed and su u ed (Fig. 1a–d).
In 18 o he cases (56.3%), an immedia e p o isional
c own was made due o he es he ic demands o he pa-
ien s. In his case, p ima y s abili y wi h an inse ion
o que > 30 Ncm was con i med and a p e- o med
polyca bona e c own o he app op ia e size was
chosen. Tha c own was o e laid wi h a sel -cu ing
esin (Tab 2000, Ke , Sca a i, I aly) and composi e
(TPH Spec um®, Den sply Si ona, Yo k, Pensil ania,
USA) and hen polished pe ec ly. The c own was
cemen ed wi h Temp-Bond (Temp-Bond™,Ke ,Sca a i,
I aly), and he occlusion was e i ied o check ha he e
was no con ac du ing cen ic o eccen ic mo emen s o
p e en loading du ing osseoin eg a ion.
Pos -ope a i e ins uc ions included amoxicillin 750
mg e e y 8 h o 8 days, dexke op o en 25 mg e e y 8 h
o 4 days, and insing wi h chlo hexidine diglucona e
0.12% wice a day o 15 days. Su u es we e emo ed
a e 7 days.
A e 6 o 8 weeks o healing and ollowing he manu-
ac u e ’s ecommenda ions, inal imp essions we e
aken using he co esponding imp ession cap wi h a
closed ay and VPS imp ession ma e ial o pu y (Emp-
ess™2 Pu y So , 3M ESPE, See eld, Ge many) and
ul a-ligh iscosi y (Emp ess™2 Ul a-Ligh Body Quick,
3M ESPE, See eld, Ge many). Due o he one-piece de-
sign o he ce amic implan , all-ce amic zi conia c owns
we e inse ed in all cases. Pe manen glass ionome ce-
men (Ke ac Cem™, 3M ESPE, See eld, Ge many) was
used o cemen he c owns di ec ly on o he implan
abu men . Special a en ion was paid o emo e all
emaining cemen .
A e placemen o he de ini i e p os hesis (T
0
), we
ca ied ou pho og aphy, in a-o al adiog aphy, and
measu emen s o p obing dep h, bleeding on p obing,
maximum dis ance om he gingi al ma gin o he inci-
sal edge, and Jem papilla index, and ook hese pa ame-
e s as he baseline om which any changes we e
e alua ed.
In each o he ollow-up appoin men s, 4 (T
4
), 8 (T
8
)
and 12 mon hs (T
12
) a e he placemen o he p os hesis,
plaque con ol was ein o ced, wha e e sup agingi al
plaque ha could be emo ed was emo ed, a pho og aph
o he es o a ion was aken, and he ollowing pa ame e s
we e eco ded by one o he esea che s (MV):
Fig. 1 Clinical case. aSu ge y, bimplan placed, c adiog aphic e alua ion a 12 mon hs, and dp os hesis a 12 mon hs
Vilo -Fe nández e al. In e na ional Jou nal o Implan Den is y (2021) 7:26 Page 3 o 8
P obing dep h (PD): pocke p obing on den al
implan s was eco ded wi h ligh o ce
(app oxima ely 0.25N) a six poin s a ound he
implan .
Bleeding on p obing (BOP) (a six poin s a ound he
implan ) [16]
Suppu a ion on p obing (SOP): local SOP sco e was
eco ded as he pe cen age o o al su aces (six
poin s pe implan ) ha exhibi ed suppu a ing on
gen le p obing wi h a ligh o ce (app oxima ely
0.25N)
Plaque index [15]
Pe i-implan ecession (Pi-Rec): he di e ence
be ween maximum dis ance om he gingi al
ma gin o he incisal edge measu ed a baseline and
1 yea - ollow-up, measu ed on he mid buccal si e.
Jem papilla index (JPI) [18]
A he las ollow-up appoin men , an X- ay was also
pe o med o assess bone changes, namely any loss o
gain as measu ed a he mesial and dis al aspec o each
implan ela i e o he baseline measu emen s a he be-
ginning o he s udy. The inal pho og aph was used o
analyze so issue changes, namely pe i-implan eces-
sion (Pi-Rec) and he s a e o he papilla acco ding o
he Jem papilla index [18].
All adiog aphic measu emen s we e aken by he
same in es iga o (RE), a baseline (T
0
) and a 12
mon hs (T
12
). Changes in he bone le el we e measu ed
bo h mesially and dis ally o he implan on a pe iapical
X- ay aken wi h a s anda dized ilm holde (Rinn® Flip-
Ray Film Holde , Rinn, Den sply In e na ional Inc. Elgin,
IL, EEUU). The leng h o he polished neck o he im-
plan (1.8 mm) se ed as a e e ence o calib a e he X-
ay be o e measu ing ma ginal bone loss (MBL) om
he neck o he implan o he i s bone-implan con ac
(BIC). A posi i e alue indica ed ha he i s BIC was
loca ed abo e he i s h ead o he implan , and a nega-
i e one indica ed ha i was loca ed below.
S a is ical analysis
The da a we e analyzed by XM using IBM SPSS so wa e
e sion 22. Fo desc ip i e s a is ics, we used he mean,
s anda d de ia ion, ank, and pe cen ages. Fo analy ical
s a is ics, he Wilcoxon signed- ank es o ela ed sam-
ples was ca ied ou . P alues o less han 0.05 we e con-
side ed s a is ically signi ican .
Resul s
Thi y- wo S aumann® PURE Ce amic implan s we e
placed by only one su geon (MV) in 28 pa ien s. The di-
ame e s o he implan s we e 3.3 and 4.1 mm, and he
leng hs anged om 8 o 14 mm. These implan s had
wo di e en abu men heigh s: 4 and 5.5 mm. Twen y-
h ee implan s we e placed in he p emola egion
(71.9%), ou in he canine posi ion (12.5%), and i e in
he la e al inciso posi ion (15.6%). The pa ien demo-
g aphics and implan cha ac e is ics a e desc ibed in
Table 1.
In nine o he su ge ies (28.12%), an addi ional bone
egene a i e p ocedu e was equi ed due o dehiscences
ha a ose om implan placemen . Addi ionally, in ou
cases (12.5%), a connec i e issue g a was placed o in-
c ease he so issue olume. I should be no ed ha no
pa ien had pos ope a i e complica ions, ins ead o wo
cases (6.25%) ha , du ing he healing phase, showed mo-
bili y and he implan had o be emo ed. Thus, he su -
i al a e ob ained in his s udy was 96.9%.
So issues
P obing dep h inc eased sligh ly o e he s udy ime. Ini-
ially, a he ime o he inal c own placemen (T0), he
mean PD was 2.81 ± 1.03 mm and i p og essi ely in-
c eased in T4, T8, and T12 wi h he mean PD o 3.31 ±
0.95 mm, 3.37 ± 0.94 mm, and 3.59 ± 1.37 mm, espec -
i ely. We obse ed a s a is ically signi ican di e ence in
Table 1 Summa y o pa ien demog aphics and implan
cha ac e is ics (n= 32 implan s)
N(%)
Pa ien da a
Sex, n16 emales
12 males
Gende : nand (%) emale 16 (57.15)
Mean age (yea s) 54.1
Age ange (yea s) 34–67
Smoke s 8 (31.3)
Implan da a
Si e o implan placemen (nand %)
La e al inciso 5 (15.6)
Canine 4 (12.5)
1s P emola 19 (59.4)
2nd P emola 4 (12.5)
Leng h o implan , n(%)
8 mm 2 (6.25)
10 mm 20 (62.5)
12 mm 8 (25)
14 mm 2 (6.25)
Immedia e implan 4 (12.5)
Bone augmen a ion, n(%) 9 (28.12)
So issue augmen a ion, n(%) 4 (12.5)
P o isional es o a ion 18 (56.3)
Follow-up (mon hs) 12
Vilo -Fe nández e al. In e na ional Jou nal o Implan Den is y (2021) 7:26 Page 4 o 8
PD be ween baseline and 12 mon hs o 0.78 mm (p =
0.002) (Fig. 2).
In ela ion o he PI [15] a he beginning, a 4, 8, and
12 mon hs a e he placemen o he p os hesis, his e-
ealed a pe cen age o su aces wi h den al plaque o
19.55 ± 7.22%, 20.53 ± 8.67%, 21.77 ± 6.35%, and 20.67
± 7.53%, espec i ely (Fig. 3).
Bleeding on p obing (BOP) emained s able h ough-
ou he s udy; hus, in T0, T4, T8, and T12 we e 23.26 ±
27.18%, 18.53 ± 16.11%, 29.5 ± 22.43%, and 26.3 ±
26.41%, espec i ely (Fig. 4). The e we e no signi ican
di e ences be ween any o he s udy imes.
I should be no ed ha o he 30 implan s s udied, a e
1 yea , 28 o hem did no ha e any Pi-Rec. Only wo im-
plan s expe ienced a Pi-Rec o 1 mm, assuming an a e age
Pi-Rec o 0.07 mm a e 1 yea o ollow-up. None o bo h
implan s showing ecession we e ei he an immedia e
implan o ea ed wi h egene a i e p ocedu es.
On he o he hand, he Jem papillae index (JPI)
showed an imp o emen ega ding he illing o he in-
e p oximal spaces, p obably, due o he ma u a ion o
he papillae. Thus, ini ially 37.5% o he cases showed an
JPI = 0, 37.5% JPI = 1, 12.5% JPI = 2, and 9.5% JPI = 3.
A e 12 mon hs, he pe cen ages we e 9.4%, 40.6%,
31.3%, and 12.5%, espec i ely. The mean JPI o T0 was
0.94, while in T12, i was 1.5, indica ing ha in se e al
o he cases he papilla was in a mo e co onal posi ion a
he end o he s udy.
Ha d issues
Ma ginal bone loss (MBL) om implan placemen o
p os he ic loading on he mesial aspec was 0.46 ± 0.53
mm (p<0.001) and on he dis al aspec 0.41 ± 0.54 mm
(p< 0.001). Twel e mon hs a e he p os he ic loading,
he mean MBL compa ed o su ge y was 0.73 ± 0.62
mm mesially and 0.83 ± 1.09 mm dis ally, bo h s a is i-
cally signi ican (p< 0.001) (Fig. 5).
Discussion
Ou pilo s udy e alua ed he s abili y o ha d and so
issues a ound S aumann® PURE Ce amic implan s, and
his s abili y is conside ed a de e mining ac o o a suc-
cess ul esul . Acco ding o he conclusions es ablished
du ing he i s Eu opean Wo kshop on Pe iodon ology,
MBL <1.5 mm a e he i s yea o loading and an add-
i ional 0.2 mm annually should be aken as a success ul
ea men [19]. To compa e he esul s a ailable in he
li e a u e, we selec ed he s udies ha include single
c owns cemen ed o e one-piece ce amic implan s. The
success a e is a a iable which ew s udies ha e men-
ioned, bu he su i al a e is epo ed by nume ous a -
icles. A sys ema ic e iew ha included nine a icles
wi h 326 pa ien s and 398 implan s, and a ollow-up
ime which anged om 12 mon hs o 5 yea s epo ed a
su i al a e o 95.6% [20], he same as he 95% epo ed
by Paye e al. [21] and simila o he 92% epo ed by
Hashim e al. [22], bo h lowe han he 100% su i al
a e epo ed he e and by Bo gono o e al. [23].
The main pu pose o his s udy was o measu e ma -
ginal bone le el changes a e 1 yea o ollow-up. The
esul s o ou s udy should be in e p e ed wi h cau ion
since he bone loss obse ed be ween su ge y and T0
should be conside ed a he han MBL, bone emodel-
ing, because a eas o he polished neck we e subc es al
a he ime o implan placemen . Twel e mon hs a e
su ge y, MBL was 0.73 mm a he mesial aspec o he
implan and 0.83 mm a he dis al aspec . These esul s
a e compa able o hose o .G assi e al. [24], who ob-
se ed an a e age MBL o 0.83 mm a e 12 mon hs. A
ecen sys ema ic e iew compa ing his kind o implan s
e sus i anium implan s (Ti implan s) epo ed an MBL
o 0.89 ± 0.18 mm a o ing zi conia implan s (Zi im-
plan s) a e 12–24 mon hs [25]. The di e ence (0.14
mm) wi h he Ti implan s was s a is ically signi ican
(p=0.053). Ano he s udy published by Kohal e al. [26]
Fig. 2 Changes in p obing dep h
Vilo -Fe nández e al. In e na ional Jou nal o Implan Den is y (2021) 7:26 Page 5 o 8
showed a highe MBL (1.31 ± 1.49 mm) be ween he
ime o implan placemen and 1 yea o ollow-up. Con-
e sely, he e a e o he s udies epo ing highe MBL,
such as ha o Gahle e al. [27], who obse ed an MBL
o 1.02 mm a e 1 yea in use.
Ou s udy did no exclude cases ha equi ed mino
bone augmen a ion p ocedu es du ing implan su ge y,
and he p os hesis p ocedu e began a 6–8 weeks pos -
su ge y, independen ly o equi ing GBR o no because
i was conside ed ha he mino GBR needed o ea
small dehiscences would no in e e e wi h os eoin eg a-
ion [28]. Like o he s udies, we used bo ine bone g a
co e ed wi h a eso bable collagen memb ane [29–31].
A e iew ha uni ied he da a o hese a icles did no
ind s a is ically signi ican di e ences in MBL be ween
applying guided bone egene a ion (0.79 mm) and no
applying i (0.97 mm) [22]. In he p esen in es iga ion,
we co obo a e his s a emen since he MBL a e 1 yea
o loading was 0.61 mm in he cases whe e GBR was no
ca ied ou compa ed o 0.94 mm in he cases whe e e-
gene a i e p ocedu es we e applied (p=0.342). Al hough
one-piece implan s do no allow p ima y closu e o he
wound, p ocedu es o mino bone augmen a ion did no
appea o ha e any signi ican e ec on MBL [22,28].
One o he ad an ages o one-piece implan s is ha hey
migh minimize bone loss by a oiding mic omo emen s
and implan -abu men mic ogaps [32]. A sys ema ic e-
iew compa ing one-piece implan s e sus wo-piece im-
plan s obse ed a s a is ically signi ican di e ence in
e ms o MBL (0.93 ± 0.19 mm s 1.46 ± 0.57 mm) [25].
Fig. 3 Changes in plaque index
Fig. 4 Changes in bleeding on p obing index
Vilo -Fe nández e al. In e na ional Jou nal o Implan Den is y (2021) 7:26 Page 6 o 8
Con e sely, he di icul y posed by hese one-piece im-
plan s is ha hey limi he p os he ic op ions o ca ying
ou he ehabili a ion. E en p epa ing he implan head is
discou aged since, as obse ed by Sil a e al. [14], i has a
nega i e in luence on implan ac u e. Fu he mo e, he
aging o his ma e ial in he p esence o humidi y a oom
empe a u e is widely known. Howe e , in i o s udies
[33,34] e alua ing he impac o low empe a u e deg ad-
a ion o Z 0
2
obse e ha he e ec o aging was minimal
o hese ce amic implan s, sugges ing a eliable clinical
applica ion o his ma e ial. Fo his eason, i is an a ea
incons an esea ch and de elopmen o achie e implan s
wi h g ea e esis ance o a igue and deg ada ion.
The e alua ion o clinical so issue pa ame e s indi-
ca ed an absence o pe i-implan biological complica-
ions, showing an a e age PD o 3.59 mm and BOP o
26.3% a e 12 mon hs. These da a a e compa able o
hose ob ained in a ecen s udy published by Balme
e al. [35] whe e hey eco ded an a e age PD o 3.47 ±
0.67 mm, which was sligh ly lowe han wha we ob-
se ed, and BOP o 57.5 ± 32.9%, which, con e sely, was
highe han wha we ob ained. In some cases, BOP could
be iden i ied as a clinical sign o mucosi is due o inco -
ec plaque con ol o mic ogaps be ween he c own and
he implan [36]. Ou p obing dep h was sligh ly highe
han ha obse ed by Cionca e al. [37] in a sys ema ic
e iew, whe e i anged om 1.8 o 3.2 mm.
Conclusions
The esul s ob ained wi h he S aumann® PURE Ce -
amic implan s show hem o exhibi e y good clinical
beha io in e ms o ha d and so issue s abili y. The
su i al a e o he implan s o ou pilo s udy was 9.9%.
Fo hese easons, we can conclude ha implan s could
be an al e na i e o i anium implan s in he es he ic
zone. Howe e , mo e long- e m clinical s udies a e
necessa y o con i m he clinical e icacy and he mech-
anical esis ance o Z 0
2
as a ma e ial o he manu ac-
u e o den al implan s.
Abb e ia ions
Z 0
2
:Zi conia; Ti: Ti anium; PD: P obing dep h; PI: Plaque index;
BOP: Bleeding on p obing; SOP: Suppu a ion on p obing; GM-IE: Dis ance
om gingi al ma gin o incisal edge; JPI: Jem papilla index; Pi-
Rec: Pe iimplan ecession; MBL: Ma ginal bone loss
Acknowledgemen s
The au ho s wish o hank he s uden s o he own mas e ’s deg ee in
pe iodon ics and osseoin eg a ion o he Uni e si y o he Basque Coun y
(UPV/EHU) o hei pa icipa ion h oughou he s udy. O cou se, we would
also like o hank S aumann o i s suppo and o p o iding he implan s
comple ely ee o cha ge.
Au ho s’con ibu ions
LAAZ was he esponsible o he design o he wo k and ha e subs an i ely
e ised i . MV was he p incipal in es iga o and a majo con ibu o in
w i ing he manusc ip . Also, she was he esponsible o all su ge ies. RE and
AMG adqui ed and in e p e ed he pa ien da a. Finally, XM analyzed all da a.
The au ho s ead and app o ed he inal manusc ip .
Funding
S aumann G oup p o ided us wi h he necessa y ma e ial o ca y ou he
in es iga ion.
A ailabili y o da a and ma e ials
The da ase s used and/o analyzed du ing he cu en s udy a e a ailable
om he co esponding au ho on easonable eques .
Fig. 5 Ma ginal bone loss a mesial and dis al si es
Vilo -Fe nández e al. In e na ional Jou nal o Implan Den is y (2021) 7:26 Page 7 o 8
Decla a ions
E hics app o al and consen o pa icipa e
This obse a ional ambispec i e clinical s udy was app o ed by he Clinical
Resea ch E hics Commi ee o he Basque Coun y (CEIC-E) (In e nal Code
PI2016088, 07/2016). In addi ion, i is egis e ed a www.ClinicalT ials.com (n°
NCT03352284).
Consen o publica ion
All pa icipan s ha e signed he consen o m.
Compe ing in e es s
Mi en Vilo -Fe nández, Ana-Ma ía Ga cía-De-La-Fuen e, Xabie Ma ichala -
Mendia, Ru h Es e anía-F esco and Luis-An onio Agui e-Zo zano decla e ha
hey ha e no compe ing in e es s.
Au ho de ails
1
Depa men o S oma ology II, Uni e si y o he Basque Coun y (UPV/EHU),
Ba io Sa iena s/n, 48940 Leioa, Bizkaia, Spain.
2
Depa men o Nu sing I,
Uni e si y o he Basque Coun y (UPV/EHU), Ba io Sa iena s/n, 48940 Leioa,
Bizkaia, Spain.
Recei ed: 17 Sep embe 2020 Accep ed: 24 Feb ua y 2021
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Publishe ’sNo e
Sp inge Na u e emains neu al wi h ega d o ju isdic ional claims in
published maps and ins i u ional a ilia ions.
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