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Q U I N T E S S E N C E I N T E R N AT I O N A L

IMPLANTOLOGY
A prospective noninterventional study to
document implant success and survival of the
Straumann Bone Level SLActive dental implant
in daily dental practice
Andreas Filippi, Prof Dr1/Frank L. Higginbottom, DDS2/Thomas
Lambrecht, Prof Dr Dr3/Barry P. Levin, DMD4/Josef L. Meier, Dr med Dr
med dent5/Paul S. Rosen, DMD, MS, PC6/Beat Wallkamm, Dr med dent7/
Christoph Will, Dr med Dr med dent8/Mario Roccuzzo, DDS9

Objectives: Clinical studies to assess dental implants are common in implantology, but
such studies are usually performed for specic indications and following a specic protoDPMXJUITUSJDUJODMVTJPOBOEFYDMVTJPODSJUFSJB5IFBJNPGUIFDVSSFOUTUVEZXBTUPFWBMVBUF
UIF4USBVNBOO#POF-FWFM4-"DUJWFEFOUBMJNQMBOUJOBQSPTQFDUJWF NVMUJDFOUFS OPOJOUFSWFOUJPOBMUSJBMMethod and Materials:5IFJNQMBOUDPVMECFVTFEJOXIBUFWFSNBOOFSXBT
EFFNFETVJUBCMFCZUIFDMJOJDJBO XJUIJOBQQSPWFEJOEJDBUJPOT/PQBSUJDVMBSQMBDFNFOUPS
MPBEJOHQSPUPDPMXBTTQFDJmFE"UPUBMPG JNQMBOUTXFSFQMBDFEJOQBUJFOUTJO
DFOUFSTJOOJOFDPVOUSJFTJOUIF64BOE&VSPQF"GUFSFYDMVTJPOPGUISFFDPVOUSJFTEVF
UPQBUJFOUFOSPMMNFOUBOEEBUBJTTVFT QBUJFOUTXJUI JNQMBOUTXFSFBOBMZ[FE
Results:.PTUQBUJFOUTSFDFJWFEPOFPSUXPJNQMBOUT BOEPGQBUJFOUT 
SFTQFDUJWFMZ
BOEPGDBTFTXFSFQFSGPSNFEXJUIBSBJTFEnBQ"TVCNFSHFEIFBMJOH
QSPUPDPMXBTTJHOJmDBOUMZNPSFQSFWBMFOUJO&VSPQFBODFOUFST XIJMFUSBOTNVDPTBMIFBMJOH
XBTTJHOJmDBOUMZNPSFQSFWBMFOUJO/PSUI"NFSJDBODFOUFST"GUFSZFBS QBUJFOUTXJUI
JNQMBOUTXFSFBWBJMBCMFGPSFWBMVBUJPO5IFDVNVMBUJWFJNQMBOUTVSWJWBMBOETVDDFTT
SBUFTXFSFBOE SFTQFDUJWFMZConclusions:5IJTQSPTQFDUJWFOPOJOUFSWFOUJPOBMTUVEZFWBMVBUFEUIFVTFPG4USBVNBOO#POF-FWFM4-"DUJWFEFOUBMJNQMBOUTJOB
MBSHFOVNCFSPGQBUJFOUT5IFDVNVMBUJWFTVSWJWBMBOETVDDFTTSBUFTXFSFTJNJMBSUPUIPTF
PCTFSWFEJODPOUSPMMFEDMJOJDBMUSJBMT DPOmSNJOHUIJTEFOUBMJNQMBOUTDMJOJDBMBQQMJDBCJMJUZJO
daily practice. (Quintessence Int 2013;44:499512; doi: 10.3290/j.qi.a29611)

Key words:CPOFMFWFMEFOUBMJNQMBOU EBJMZEFOUBMQSBDUJDF OPOJOUFSWFOUJPOBMTUVEZ 


4-"DUJWF
1

Department of Oral Surgery, Oral Radiology and Oral Medicine,

Germany.

land.
2

Professor, Restorative Sciences and Graduate Prosthodontics,


Dallas, TX, USA.

Private Practice; Specialist in Oral and Maxillofacial Surgery;


Zentrum fr zahnrztliche Chirurgie Implantologie, Kitzingen,

School of Dental Medicine, University of Basel, Basel, Switzer-

Private Practice, Torino, Italy; and Lecturer in Periodontology,


University of Siena, Italy.

Department of Oral Surgery, Oral Radiology and Oral Medicine,

Correspondence: Dr Mario Roccuzzo, Corso Tassoni 14, 10143

School of Dental Medicine, University of Basel, Basel, Switzer-

Torino, Italy. Email: mroccuzzo@iol.it.

land.
4

Clinical Associate Professor, University of Pennsylvania, Department of Graduate Periodontology; and Private Practice, Elkins
Park, PA, USA.

Private Practice and In-patient Doctor; Specialist in Oral and


Maxillofacial Surgery; MKG-Landshut Praxisklinik fr MKGChirurgie, Implantologie und Parodontologie, Landshut, Germany.

Clinical Associate Professor of Periodontics, Baltimore College


of Dental Surgery, University of Maryland Dental School, Baltimore, MD, USA; and Private Practice, Yardley, PA, USA.

Specialist in Periodontology SSO, Clinical Associate Professor,

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predictable support for dental prostheses,
from single crowns to full-arch xed dental
QSPTUIFTFT BOE PWFSEFOUVSFT 5IF TVDcess of dental implants in patients has been
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GPS PWFS  ZFBST 4VDI DMJOJDBM TUVEJFT UP
BTTFTT EFOUBM JNQMBOU TVSWJWBM SBUFT BSF

University of Berne, Department of Periodontology; and Private

common in implantology, and the results

Practice, Langenthal, Switzerland.

are often cited by dental implant manufac-

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Q U I N T E S S E N C E I N T E R N AT I O N A L
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turers as proof of the success of their prod-

esthetic implant treatment is therefore to

ucts.  )PXFWFS  UIFTF TUVEJFT BSF VTVBMMZ

NJOJNJ[FCPOFMPTTBTNVDIBTQPTTJCMF

performed according to a protocol with

"CPOFMFWFMJNQMBOUXJUIBTBOECMBTUFE 

strict inclusion and exclusion criteria, which

large-grit, acid-etched, and hydrophilic sur-

dictates the enrollment of patients with spe-

GBDF 4-"DUJWF
IBTCFFOEFWFMPQFEXJUIB

DJmD EFOUBM TJUVBUJPOT  PS BJN UP JOWFTUJHBUF

WJFX UP PCUBJOJOH NPSF QSFEJDUBCMF PVU-

a specic indication. One potential criticism

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of such studies, therefore, is that they may

#POF -FWFM JNQMBOU JT EFTJHOFE UP CF

OPU BDDVSBUFMZ SFnFDU UIF XJEF WBSJFUZ PG

placed with the neck of the implant at the

patients and situations seen in normal daily

TBNF MFWFM BT UIF DSFTUBM CPOF 6OMJLF TPGU

EFOUBM QSBDUJDF 5IF DMJOJDJBOT JOWPMWFE JO

UJTTVFMFWFMJNQMBOUT UIFCPOFMFWFMJNQMBOU

such formal clinical trials may potentially

has no metallic tulip-shaped shoulder, so

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UIBUUIFWJTJCJMJUZPGBOZHSBZNFUBMMJDTIBEPX

patients in the trial, due to the study set-up.

through the soft tissue can be eliminated.

*O BEEJUJPO  UIF DMJOJDJBOT JOWPMWFE JO UIFTF

1SFDMJOJDBM TUVEJFT FWBMVBUJOH UIF QMBUGPSN

DMJOJDBMUSJBMTBSFVTVBMMZTQFDJBMJTUTPSIBWF

TXJUDIJOH DPODFQU XJUI UIJT JNQMBOU IBWF

additional training in a particular dental dis-

TIPXO WFSZ MJUUMF CPOF MPTT BOE OP TJHOJm-

cipline, and this may increase the likelihood

cant differences between submucosal and

PG IJHIFS JNQMBOU TVSWJWBM9 For these rea-

transmucosal healing approaches. 5IF

sons, formal clinical trials may be biased

SFTVMUT XFSF JO MJOF XJUI UIPTF PCTFSWFE JO

UPXBSETNPSFGBWPSBCMFPVUDPNFT

TJNJMBSQSFWJPVTTUVEJFT   but with smaller

5P NJOJNJ[F TPNF PG UIF DSJUJDJTNT MFW-

DSFTUBMCPOFMPTTWBMVFTNFBOCPOFMPTT

ied as to the applicability of a highly con-

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trolled institution-based study to clinical

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QSJWBUF QSBDUJDF  B OPOJOUFSWFOUJPOBM TUVEZ

JNQMBOUT QMBDFE BCPWF  CFMPX  PS BU UIF

could be designed and initiated for the

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FWBMVBUJPOPGBQBSUJDVMBSNFEJDBMEFWJDF*O

NN  NN BOE NN GPS

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USBOTNVDPTBM JNQMBOUT QMBDFE BCPWF 

question would be used in the manner for

CFMPX BOEBUUIFDSFTUBMCPOFMFWFM SFTQFD-

XIJDIJUIBTCFFOBQQSPWFE CVUUIFBTTJHO-

UJWFMZ " TFDPOE TUVEZ XJUI B TJNJMBS QSPUP-

ment of patients to a particular therapeutic

col showed bone-to-implant contact per-

strategy would not be determined by a

DFOUBHFT  NPOUIT BGUFS MPBEJOH PG  

clinical trial protocol. Instead, treatment is

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determined according to the standard cur-

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rent practice of the clinician, independent of

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the decision to include the patient in the

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TUVEZ )PXFWFS  UIF VTBHF PG UIF QSPEVDU

CPOFDSFTUMFWFM SFTQFDUJWFMZ

would be systematically documented and

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BOBMZ[FE 5IF JOUFOUJPO PG TVDI B OPOJOUFS-

BUF UIF TVDDFTT BOE TVSWJWBM PG 4USBVNBOO

WFOUJPOBM TUVEZ JO UIF DPOUFYU PG EFOUBM

#POF -FWFM 4-"DUJWF JNQMBOUT JO EBJMZ EFOUBM

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practice in normal clinical situations for up to

results of controlled clinical studies in a

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real-world situation.
*NQMBOUPVUDPNFTBSFJOnVFODFECZUIF
implant design as well as the surgical pro-

METHOD AND MATERIALS

DFEVSF 5IFSF JT B XJEF WBSJFUZ PG JNQMBOU


an emphasis in recent years on implants

Clinicians, patients, and


implants

and

designs and surfaces on the market, with


for

5IJT TUVEZ XBT B QSPTQFDUJWF  NVMUJDFOUFS 

JNQSPWFE FTUIFUJD SFTVMUT  Esthetic out-

OPOJOUFSWFOUJPOBM TUVEZ VTJOH 4USBVNBOO

comes depend mainly on the amount of

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peri-implant bone remodeling, which can

4USBVNBOO
 5IF JNQMBOUT XFSF BMMPXFE UP

CF JOnVFODFE CZ UIF JNQMBOU EFTJHO Fol-

CFVTFEJOBMMBQQSPWFEJOEJDBUJPOTBOEBMM

lowing implant placement, the goal with

implant therapies at the discretion of each



surgical

procedures

designed

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Q U I N T E S S E N C E I N T E R N AT I O N A L
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JOEJWJEVBMDMJOJDJBO$MJOJDJBOTXFSFBMMPXFE

PCUBJOFE%FNPHSBQIJDEBUB BHF TFY BOE

UPUBLFQBSUJOUIFTUVEZQSPWJEFEUIBUUIFZ

SBDF
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were generally familiar with and legally

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allowed to perform dental implant treat-

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NFOU 5IF FYQFSJFODF BOE FEVDBUJPOBM

EFOUBM TJUVBUJPO OVNCFS BOE QPTJUJPO PG

background of participating clinicians was

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assessed by internet-based background

XFSF SFDPSEFE 1BUJFOUT XFSF BMTP FWBMV-

searches. Patients were eligible to partici-

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pate if their general medical condition was

periodontitis, insufcient oral hygiene, brux-

sufcient to allow an oral surgical proced-

JTN  BOE IPSJ[POUBMWFSUJDBM CPOF EFGFDUT




ure and if dental implant treatment was

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JOEJDBUFE GPS UPPUI SFTUPSBUJPO /P TQFDJmD

bolic diseases, medication, alcohol or drug

inclusion or exclusion criteria were applied,

abuse, radiotherapy, tumor surgery, chronic

and there was no general medical condition

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where oral surgical procedures were contra-

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indicated. Patient willingness to consent to

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participation in the study was necessary,

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BOEUIFUZQFPGIFBMJOHQSP-

and data collection and analysis were

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EFTJHOFE UP QSFTFSWF UIF BOPOZNJUZ PG UIF

TFNJTVCNFSHFE
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BCVUNFOU VTFE XBT SFDPSEFE 5IF UJNF

formed according to the World Medical

since the tooth to be replaced was lost or

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SFNPWFE XBT SFDPSEFE BOE DBUFHPSJ[FE

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TUVEZ IBT CFFO JOEFQFOEFOUMZ SFWJFXFE

Consensus Conference:

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t UZQF  JNNFEJBUF QMBDFNFOU BT QBSU PG

committees of each participating country,


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*OTUJUVU4USBVNBOO
IBEBCPEZEJBNFUFSPG
NNBOEMFOHUITPG   PSNN
" WBSJFUZ PG BCVUNFOUT XFSF BMMPXFE UP CF
VTFE JODMVEJOHQSPWJTJPOBMBCVUNFOUT TPMJE
abutments,

Meso

the same surgical procedure


t UZQF  FBSMZ QMBDFNFOU XJUI TPGU UJTTVF

where applicable.

abutments,

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t UZQFFBSMZQMBDFNFOUXJUIQBSUJBMCPOF
IFBMJOH UPXFFLT

t type 4: late placement in fully healed site


NPOUIT


anatomic

abutments, gold abutments, and Locator

Implant loading

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*O UIF FWFOU PG TFDPOETUBHF TVSHFSZ GPS

to be used within their standard indications

TVCNFSHFE JNQMBOUT
 UIF UZQF PG TFDPOE-

BOE SFDPNNFOEBUJPOT GPS VTF /P QBSUJDV-

ary component and any complications were

lar implant placement or loading protocol

recorded. Loading protocols followed the

XBT TQFDJmFE BMM TVSHJDBM QSPUPDPMT GSPN

normal time schedules followed in each

immediate implant placement in extraction

center. Implants were loaded with single

TPDLFUTUPQMBDFNFOUJOTJUFTIFBMFEGPS

crowns, splinted crowns, or xed partial

XFFLTBOEPWFSXFSFBMMPXFE BOEBMMMPBE-

dentures, or full- or partial-arch prostheses.

JOH QSPUPDPMT GSPN JNNFEJBUF XJUIJO 

For temporary and nal restoration, the type

IPVST BGUFS QMBDFNFOU


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of restoration was recorded, implant suc-

NPOUIT BGUFS QMBDFNFOU


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DFTT BOE TVSWJWBM DSJUFSJB XFSF FWBMVBUFE 

the discretion of each participating clini-

DPNQMJDBUJPOT XFSF OPUFE  BOE TVCKFDUJWF

DJBO"MMJNQMBOUTXFSFUPCFQMBDFEBDDPSE-

SBEJPHSBQIJD CPOF MFWFM FYBNJOBUJPO XBT

ing to normal treatment protocols and the

performed. Implant loading was performed

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BDDPSEJOHUPUIFJOEJWJEVBMQBUJFOUTJUVBUJPO 
BOEUIFMPBEJOHQSPUPDPMTXFSFDBUFHPSJ[FE

Surgical procedures and


assessments

according to the criteria by Cochran et al:


t Immediate

restoration:

restoration

Patient examination was performed at a

QMBDFE PVU PG PDDMVTJPO XJUIJO  IPVST

QSFTVSHFSZWJTJU BOEJOGPSNFEDPOTFOUXBT

of implant surgery

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Q U I N T E S S E N C E I N T E R N AT I O N A L
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t Immediate loading: restoration placed in

RESULTS

PDDMVTJPOXJUIJOIPVSTPGJNQMBOUTVSgery
t Early loading: restoration placed at least

Patients, clinicians,
and implants

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NPOUIT

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t $POWFOUJPOBMMPBEJOHSFTUPSBUJPOQMBDFE

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in a second procedure after a healing

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"

QFSJPE PG  UP  NPOUIT BGUFS JNQMBOU

UPUBMPGQBUJFOUTSFDFJWFE JNQMBOUT

surgery

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t %FMBZFEMPBEJOHSFTUPSBUJPOQMBDFEJOB

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ZFBST
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after implant surgery.

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5IFSFBTPOTGPSUPPUIMPTTBSFEFUBJMFEJO5BCMF

Follow-up evaluations

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TUVEZ  FBDI QMBDJOH  JNQMBOUT PO BWFS-

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BHF SBOHF   UP  JNQMBOUT NPEF  

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the participating clinicians is presented in

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periodontists, and 44 were classied as

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general dentists. In addition to the academic

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but were performed according to each

cians were specialists in oral implantology.


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DMJOJDTTUBOEBSEQSPDFEVSF
Implant success was dened according

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tered in centers from three of the countries

t absence of pain

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t absence of recurrent peri-implant infection

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t absence of tactile mobility

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t absence of continuous peri-implant radio-

countries had a documented nal restoraUJPO


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lucency.
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in place, whether functionally successful or

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not. Implant failure was dened by implant

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decided to exclude these countries from the

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analysis. In the remaining six countries, a


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Endpoints

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all subsequent results.

UIF

NFBO

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test with a two-tailed distribution and two-

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risk factor was the use of concomitant

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tically signicant.

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5IF
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Enrollment:
852 patients, 1,532 implants
Implantation:
759 patients, 1,355 implants

Belgium, Netherlands, Spain


excluded from analysis
9 implant failures

Provisional restoration:
653 patients, 1,134 implants
1 implant failure
Final restoration:
643 patients, 1,113 implants

1 implant failure,
3 of unknown status

1-year follow-up:
538 patients, 908 implants

Fig 1 Number of patients and implants. The number of patients and implants are depicted from the patient
enrollment until the 1-year follow-up: 759 patients received a total number of 1,355 implants at the implantation visit. After 1 year, 538 patients and 908 implants were still included in the study. The implant failures
between the visits are presented. In total, 11 implants failed during the rst year after placement and 3 were
of unknown status.

Table 1

Reasons for tooth loss: the reason for tooth loss was recorded for all
patients enrolled in the study

Reason

No. of implants (%)

Periodontitis

 

Caries

 

Unsuccessful endodontic treatment

 

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Loss due to trauma

 

Congenitally missing

 

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Other

 

5PUBM

  

43%
General dentists

6%
Periodontists

51%
Oral and
maxillofacial
surgeons

Fig 2 Educational background of the 102 participating clinicians. Among the 102 participating clinicians from 6 countries, the academic education was
evaluated by internet-based background checks; 52
were identied as oral and maxillofacial surgeons
based on reported comprehensive education in this
eld, 6 were periodontists, and 44 were classied as
general dentists. Clinicians were classied as general
dentists if not reported otherwise. Besides the academic background, 19 clinicians could be classied
as specialists in dental implantology due to reported
education.

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disease other than diabetes mellitus, tumor

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PSBMIZHJFOFTDPSFT 

BOEPGJNQMBOUT SFTQFDUJWFMZ


XJUI FYDFMMFOU TDPSFT JO  POMZ 

XFSF NN MPOH BOE  XFSF NN

TIPXFE B CBE PSBM IZHJFOF TDPSF 5IF

MPOH *O UPUBM   PG UIF JNQMBOUT XFSF

NBKPSJUZ PG UIF QBUJFOUT 


 XFSF OPO-

QMBDFE JO UIF NBYJMMB BOE  XFSF

smokers.

QMBDFEJOUIFNBOEJCMF5IFEFUBJMFEJNQMBOU

.PTU QBUJFOUT SFDFJWFE POF PS UXP

distribution according to the tooth position

JNQMBOUT  BOE  PG QBUJFOUT 

JT TIPXO JO 'JH *O UPUBM   JNQMBOUT

SFTQFDUJWFMZ
XIJMFBOESFDFJWFE


 XFSF QMBDFE JO UIF FTUIFUJD SFHJPO

UISFF BOE GPVS JNQMBOUT  SFTQFDUJWFMZ 5IF

QPTJUJPOT  UP  BDDPSEJOH UP '%* 8PSME

SFNBJOJOH QBUJFOUT SFDFJWFE CFUXFFO mWF

%FOUBM'FEFSBUJPOOPUBUJPO


120

Number of implants

100
80
60
40
20
0
18

17

16

15

14

13 12 11 21 22 23
FDI tooth position - maxilla

24

25

26

27

28

38

37

36

35

34

33 32 31 41 42 43 44
FDI tooth position - mandible

45

46

47

48

a
120

Number of implants

100
80
60
40
20
0
b

Fig 3 Implant distribution according to tooth position. The number of implants per tooth position is depicted in the maxilla (a) and in the mandible (b), according to the FDI World Dental Federation notation. A total
of 649 implants (47.9%) were placed in the esthetic region (positions 14 to 24).



VOLUME 44t/6.#&37t+6-:"6(6452013

Q U I N T E S S E N C E I N T E R N AT I O N A L
Fi l i p p i e t a l

Surgical procedures

SFDPSEFE5IFCPOFRVBMJUZSFDPSEFEBUUIF

5IFUJNFCFUXFFOUPPUIMPTTPSUPPUIFYUSBD-

QPTJUJPOPGFBDIJNQMBOUJTTIPXOJO5BCMF

tion and implantation was recorded for the

1SJNBSZTUBCJMJUZXBTBDIJFWFEGPSPG

  JOTFSUFE JNQMBOUT 5IF UJNJOH PG

implants placed.

JNQMBOUQMBDFNFOUXBTDBUFHPSJ[FEBTUZQF

5IF IFBMJOH QSPUPDPM VTFE JT TIPXO JO

UP BDDPSEJOHUPUIF1SPDFFEJOHTPGUIF

5BCMF 4JNJMBS UP UIF UJNJOH PG JNQMBOU

*5* $POTFOTVT $POGFSFODF 5BCMF




QMBDFNFOU UIFSFXBTBEJGGFSFODFPCTFSWFE

5IFSFXBTBEJGGFSFODFFWJEFOUCFUXFFOUIF

in the healing protocol between the Euro-

&VSPQFBO BOE /PSUI "NFSJDBO DFOUFST *O

QFBO BOE /PSUI "NFSJDBO DFOUFST &VSP-

European centers implants were preferably

pean centers predominantly used a sub-

QMBDFE MBUF BGUFS UPPUI FYUSBDUJPO 

NFSHFEQSPUPDPM PGJNQMBOUT
XIJMF

UZQF   NPOUIT BGUFS UPPUI FYUSBDUJPO




/PSUI "NFSJDBO DFOUFST QSFEPNJOBOUMZ

while only a minority of implants were

FNQMPZFE USBOTNVDPTBM IFBMJOH  PG

placed immediately after tooth extraction

JNQMBOUT
 5IFTF IFBMJOH QSPUPDPMT XFSF

 UZQF  JNNFEJBUFMZ BGUFS UPPUI

TJHOJmDBOUMZ EJGGFSFOU P


 CFUXFFO

FYUSBDUJPO
 *O DPOUSBTU  JO /PSUI "NFSJDBO

&VSPQFBOE/PSUI"NFSJDB)PXFWFS UIFSF

centers the majority of implants were prefer-

was no signicant difference for semi-sub-

BCMZQMBDFEFJUIFSJNNFEJBUFMZ UZQF

NFSHFEIFBMJOH JO&VSPQFBODFOUFST


PSMBUFBGUFSUPPUIFYUSBDUJPO UZQF

DPNQBSFEUPJO/PSUI"NFSJDBODFO-


 5IVT  UIFSF XFSF TJHOJmDBOU EJGGFSFODFT

UFSTP


in the timing of implant placements between


UIF &VSPQFBO BOE /PSUI "NFSJDBO DFOUFST

Provisional and final restoration

PWBMVFTTIPXOJO5BCMF
'JHVSFTIPXT

0G   JNQMBOUT JO  QBUJFOUT XIFSF

an exemplary case of a patient whose man-

EBUB XFSF BWBJMBCMF GPS FWBMVBUJPO BU UIF

dibular right rst premolar was extracted 4

QSPWJTJPOBM SFTUPSBUJPO TUBHF  UIFSF XFSF

weeks prior to implant placement.

OJOFJNQMBOUGBJMVSFT 'JH
1SPWJTJPOBMSFT-

" TVSHJDBM QSPDFEVSF XIFSF B nBQ XBT

UPSBUJPO XBT QFSGPSNFE GPS  JNQMBOUT

FMFWBUFE XBT QFSGPSNFE JO  PG DBTFT 


%BUBGSPNBUPUBMPG JNQMBOUT

XIJMF B nBQMFTT QSPDFEVSF XBT QFSGPSNFE

JOQBUJFOUTXFSFBWBJMBCMFGPSBOBMZTJTBU

JO POMZ  PG DBTFT GPS UIF SFNBJOJOH

UIF mOBM SFTUPSBUJPO TUBHF 'JH


 BOE POF

cases the surgical procedure was not

BEEJUJPOBM JNQMBOU GBJMVSF XBT OPUFE JF  BMM

Table 2

Classification for the timing of implant placement. The time between


tooth loss or extraction and implantation was categorized according to
the Proceedings of the ITI Consensus Conference.19 Absolute numbers
of implants and percentages (in parentheses) are shown according to
region.

Classification

United States/Canada

5ZQFEJSFDUMZBGUFSUPPUIFYUSBDUJPO
JNNFEJBUFQMBDFNFOU

  

  

 

  

  

 

5ZQFoXFFLTQPTUFYUSBDUJPO
FBSMZQMBDFNFOUXJUIQBSUJBMCPOFIFBMJOH

 

 

 

5ZQFXFFLT
MBUFQMBDFNFOU

  

  

 

5PUBM

 

  

  

5ZQFoXFFLTQPTUFYUSBDUJPO
FBSMZQMBDFNFOUXJUITPGUUJTTVFIFBMJOH

Europe

Overall

4UBUJTUJDBMMZTJHOJmDBOUEJGGFSFODF P
CFUXFFOUIFSFHJPOT TUBUJTUJDBMMZTJHOJmDBOUEJGGFSFODF P
CFUXFFO
the regions.

VOLUME 44t/6.#&37t+6-:"6(6452013



Q U I N T E S S E N C E I N T E R N AT I O N A L
Fi l i p p i e t a l

i
Fig 4 Exemplary clinical case. The placement of an implant into the extracted site
of the mandibular right rst premolar and
subsequent restoration are shown. Surgical treatment was performed 4 weeks
after extraction and soft tissue healing (a).
Full ap elevation revealed a wide defect
aecting the adjacent teeth (b), which was
treated with scaling, EDTA (ethylenediaminetetraacetic acid) and Straumann
Emdogain (c) prior to implant placement
(d). Bone grafting using demineralized
bovine bone mineral (e) was performed
before suturing for submerged implant
healing (f). The clinical situation 16 weeks
after surgery with healthy peri-implant
soft tissues (g) allowed impression taking
(h). The nal ceramic crown is shown in
place with a shallow probing depth (i),
stable peri-implant soft tissues (j), and the
respective radiographic image (k).

GBJMVSFT IBE CFFO QSFWJPVTMZ SFDPSEFE BU

FJHIUDBTFTPGSBEJPMVDFODZ 
BOEGPVS

UIFQSPWJTJPOBMSFTUPSBUJPOWJTJU
5IFDVNV-

DBTFTPGQFSJJNQMBOUJUJT 


MBUJWF JNQMBOU TVSWJWBM SBUF XBT UIFSFGPSF

5BCMF TIPXT UIF UZQFT PG SFTUPSBUJPOT

 BU UIJT TUBHF 1SPCMFNT XJUI UIF

used at the nal restoration stage. Most

JNQMBOUTXFSFOPUFEJODBTFT JODMVEJOH

SFTUPSBUJPOT XFSF DFNFOUFE  PG



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Table 3

Bone quality: at the implantation visit, bone quality was recorded at the
position of each implant

Bone quality

No. of implants

5ZQF

Frequency (%)





5ZQF





5ZQF





5ZQF

79



6OLOPXONJTTJOH
5PUBM

Table 4





 



Implant healing protocol according to region: implants were allowed to


heal according to one of the three healing protocols indicated

Healing protocol

United States/Canada

Europe

Overall

4VCNFSHFE

  

  

4FNJTVCNFSHFE

 

 

 

5SBOTNVDPTBM

  

  

 

6OLOPXONJTTJOH
5PUBM

 

 

 

 

 

  

  

4UBUJTUJDBMMZTJHOJmDBOUEJGGFSFODF P
CFUXFFOUIFSFHJPOT EJGGFSFODFOPUTUBUJTUJDBMMZTJHOJmDBOU P

between the regions

Table 5

Type of restoration recorded at the final restoration visit

Type of restoration

No. of implants

Frequency (%)

4JOHMFDSPXO





'JYFEQBSUJBMEFOUVSFT JODMVEJOHDBOUJMFWFS





Full-arch prosthesis



9.4





Partial-arch prosthesis
6OLOPXONJTTJOH
5PUBM





 



JNQMBOUT
TDSFXSFUFOUJPOXBTVTFEJOPOMZ

WT<P>GPSJNNFEJBUFMPBE-

PGDBTFT BOEPUIFSUZQFTPGSFUFOUJPO

JOHBOEWT<P>GPSJNNFEJ-

XFSF VTFE JO  PG DBTFT $POWFOUJPOBM

BUFSFTUPSBUJPO


implant loading was predominantly used


MPBEJOH 
BOEFBSMZMPBEJOH 


Implant survival and success and


bone measurements after 1 year

5BCMF
$POWFOUJPOBMMPBEJOHXBTTJHOJm-

"GUFSZFBS BUPUBMPGQBUJFOUTXJUI

DBOUMZNPSFQSFWBMFOUJOUIF&VSPQFBODFO-

JNQMBOUT XFSF BWBJMBCMF GPS FWBMVBUJPO

UFSTUIBOUIF/PSUI"NFSJDBODFOUFST 

'JH
 "U UIJT TUBHF  UIFSF XBT POF BEEJ-

DPNQBSFE UP  P


 *NNFEJBUF

UJPOBM JNQMBOU GBJMVSF SFDPSEFE EVF UP MPTT

MPBEJOH BOE SFTUPSBUJPO XFSF NPSF QSFWB-

PG PTTFPJOUFHSBUJPO
 BOE UISFF JNQMBOUT

MFOUJOUIF/PSUI"NFSJDBODFOUFST IPXFWFS

where data were unknown or missing.

the differences were statistically not signi-

5BLFOUPHFUIFS BUPUBMPGJNQMBOUTFJUIFS

cant compared to the European centers

GBJMFEPSIBEBMBDLPGEPDVNFOUFETVSWJWBM

 PG JNQMBOUT


 GPMMPXFE CZ EFMBZFE

VOLUME 44t/6.#&37t+6-:"6(6452013



Q U I N T E S S E N C E I N T E R N AT I O N A L
Fi l i p p i e t a l

within the rst year after implant placement,

to the success criteria were reported within

SFTVMUJOH JO B DVNVMBUJWF TVSWJWBM SBUF PG

the rst year after implant placement, which

 CBTFEPOJNQMBOUTBGUFSZFBS

SFTVMUFE JO B DVNVMBUJWF TVDDFTT SBUF PG

Few problems with the implants were

 CBTFEPOJNQMBOUTBGUFSZFBS

OPUFEBUUIFZFBSGPMMPXVQ JODMVEJOHmWF

8IFSF SBEJPHSBQIJD CPOF MFWFM XBT

DBTFT PG QFSJJNQMBOUJUJT  PG JNQMBOUT




FWBMVBUFE  UIFSF XBT OP DIBOHF JO DSFTUBM

BOE POF DBTF PG SBEJPMVDFODZ 


 5IF

CPOFMFWFMBUUIFNBKPSJUZPGJNQMBOUT 

PWFSBMM TVDDFTT SBUF PG UIF CPOF MFWFM

BOE  NFTJBM BOE EJTUBM


 5BCMF


implants was calculated based on the suc-

$IBOHFJOCPOFMFWFMPGHSFBUFSUIBONN

DFTT DSJUFSJB BT QVCMJTIFE CZ #VTFS FU BM

XBT PCTFSWFE BU MFTT UIBO  PG JNQMBOUT

5IFSFGPSF  JG BO FWFOU TVDI BT QBJO  QFSJ

 BOE  NFTJBM BOE EJTUBM


 XIJMF

implantitis, mobility, or radiolucency was

CPOFHSPXUIXBTPCTFSWFEJOBSPVOEPG

reported, they were counted as unsuccess-

DBTFT  BOE  NFTJBM BOE EJTUBM




GVM JNQMBOUT  JSSFTQFDUJWF PG XIFUIFS UIF

%VF UP UIF OPOJOUFSWFOUJPOBM OBUVSF PG UIF

FWFOUXBTUSBOTJFOUPSQFSTJTUFOU/PEJTUJOD-

study, no radiographs were acquired for the

UJPOJOUIFQFSTJTUFODFPGBOFWFOUXBTNBEF

remaining implants because this was not

EVSJOHEBUBBDRVJTJUJPO"UPUBMPGDPNQMJ-

part of the standard procedure of the

DBUJPOT QSPCMFNTBOEPSGBJMVSFTUIBUBQQMJFE

SFTQFDUJWFEFOUBMQSBDUJUJPOFST

Table 6

Implant loading protocol: numbers of implants and percentages (in


parentheses) according to region
Europe

Overall

Immediate loading

Loading protocol

  

  

 

Immediate restoration

 

 

 

Early loading

  

  

 

$POWFOUJPOBMMPBEJOH

 

 

 

%FMBZFEMPBEJOH

# 

# 

 

6OLOPXONJTTJOH
5PUBM

United States/Canada

 

 

 

 

 

  

%JGGFSFODFOPUTUBUJTUJDBMMZTJHOJmDBOU P
 EJGGFSFODFOPUTUBUJTUJDBMMZTJHOJmDBOU P 
 difference not statistiDBMMZTJHOJmDBOU P
 EJGGFSFODFTUBUJTUJDBMMZTJHOJmDBOU P
 #EJGGFSFODFOPUTUBUJTUJDBMMZTJHOJmDBOU P


Table 7

Crestal bone level: the number (%) of implants with mesial and distal
radiographic bone level changes is indicated at the 1-year follow-up
Mesial

Distal

/PDIBOHF

 

 

NN

 

 

oNN

 

 

 

oNN

 

oNN

 

 

oNN

 

 

NN

 

 

 

 

/PUFWBMVBUFEPSVOLOPXO

 

 

5PUBM

 

 

#POFHSPXUI



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Q U I N T E S S E N C E I N T E R N AT I O N A L
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Complications

 4JODF UIF DVNVMBUJWF TVSWJWBM SBUF

Complications were documented through-

includes all failed or undocumented cases

PVUUIFFOUJSFTUVEZ5IFGPMMPXJOHDPNQMJDB-

PVU PG UIF JOJUJBM   JNQMBOUT  JU JT B DPO-

tions

TFSWBUJWF NFBTVSF PG UIF FGGFDUJWF TVSWJWBM

were

reported

at

second

stage

TVSHFSZGPSNBUJPOPGmTUVMB DBTFT
DPN-

SBUF *O UFSNT PG JNQMBOU TVDDFTT   DPN-

QMJDBUJPOT XJUI SFHFOFSBUJWF QSPDFEVSFT 

QMJDBUJPOT  QSPCMFNT  BOEPS GBJMVSFT XFSF

DBTFT
 BOE FYDFTTJWF CPOF SFTPSQUJPO 

reported that apply to the success criteria

DBTF
 "U QSPWJTJPOBM SFTUPSBUJPO  DPNQMJDB-

PG #VTFS FU BM within the rst year after

UJPOT XJUI QSPTUIFUJDT  DBTFT


 FYDFTTJWF

implant placement, which resulted in a

CPOF SFTPSQUJPO  DBTFT


 DPNQMJDBUJPOT

DVNVMBUJWF TVDDFTT SBUF PG  "T XJUI

XJUITPGUUJTTVFNBOBHFNFOU DBTFT
QBJO

UIF DVNVMBUJWF TVSWJWBM SBUF  UIJT QFSDFOU-

DBTF
BOEJNQMBOUNPCJMJUZ DBTF
XFSF

BHF JT MJLFMZ UP VOEFSFTUJNBUF UIF FGGFDUJWF

SFQPSUFE"UmOBMSFTUPSBUJPO DPNQMJDBUJPOT

rate, because all reports from the initial

XJUI TPGU UJTTVF NBOBHFNFOU  DBTFT




  JNQMBOUT XFSF DPVOUFE BOE UIFO

DPNQMJDBUJPOT XJUI QSPTUIFUJDT  DBTFT




SFMBUFE UP UIF SFNBJOJOH  JNQMBOUT

GPSNBUJPO PG mTUVMB  DBTF


 BOE JNQMBOU

5IFTF SBUFT XFSF DPNQBSBCMF XJUI UIPTF

NPCJMJUZ  DBTF
 XFSF SFQPSUFE 'JOBMMZ  BU

PCTFSWFE JO GPSNBM DPOUSPMMFE DMJOJDBM USJBMT

UIF ZFBS GPMMPXVQ  UIF GPMMPXJOH DPNQMJ-

XJUINPSFSFTUSJDUJWFQBUJFOUTFMFDUJPONFUI-

cations were reported: complications with

PET 'PS FYBNQMF  ZFBS SFTVMUT GSPN B

QSPTUIFUJDT DBTFT
TPGUUJTTVFJOnBNNB-

SBOEPNJ[FE  DPOUSPMMFE DMJOJDBM TUVEZ XJUI

UJPO  DBTFT
 SBEJPMVDFODZ  DBTF
 QBJO

 4USBVNBOO #POF -FWFM 4-"DUJWF

 DBTF
 DPNQMJDBUJPOT XJUI TPGU UJTTVF

JNQMBOUT QMBDFE JO  QBUJFOUT XJUI FJUIFS

NBOBHFNFOU DBTF
BOEFYDFTTJWFCPOF

submerged

SFTPSQUJPO DBTF


TIPXFEJNQMBOUTVSWJWBMSBUFTPGBOE

or

transmucosal

healing

GPSUIFTVCNFSHFEBOEUSBOTNVDPTBM
HSPVQT  SFTQFDUJWFMZ 4VSWJWBM BOE TVD-

DISCUSSION

DFTT SBUFT PG  XFSF BMTP GPVOE JO B


TJOHMF DPIPSU TUVEZ FWBMVBUJOH 4USBVNBOO

5IF VTF PG EFOUBM JNQMBOUT GPS UIF SFTUPSB-

#POF-FWFM4-"DUJWFJNQMBOUTQMBDFEJO

tion of missing, lost, or extracted teeth has

DPOTFDVUJWFQBUJFOUTJOTJOHMFUPPUIHBQTJO

become a widely accepted treatment solu-

UIFFTUIFUJD[POFBGUFSBIFBMJOHQFSJPEPG

tion, and patient demands in terms of

UP  XFFLT In this study, success and

esthetics and timely restoration of function

TVSWJWBM SFNBJOFE VODIBOHFE VQ UP 

IBWFESBNBUJDBMMZJODSFBTFEJOSFDFOUZFBST

years.

$MJOJDJBOTBOEJOEVTUSZIBWFUIFSFGPSFUSJFE

5IF QSFTFOU TUVEZ SFWFBMFE DFSUBJO EJG-

UPEFWFMPQOFXUFDIOJRVFTBOEQSPEVDUTUP

ferences in the surgical protocol between

BDIJFWF UIJT  JODMVEJOH CPUI OFX TVSHJDBM

&VSPQFBO BOE /PSUI "NFSJDBO TUVEZ DFO-

procedures and implant designs.

UFST &VSPQFBO DFOUFST QSFEPNJOBOUMZ

5IF QVSQPTF PG UIJT MBSHF QSPTQFDUJWF

FNQMPZFE MBUF JNQMBOU QMBDFNFOU 




NVMUJDFOUFS OPOJOUFSWFOUJPOBM USJBM XBT UP

BOEBTVCNFSHFEIFBMJOHQSPUPDPM 


FWBMVBUF UIF QFSGPSNBODF PG 4USBVNBOO

XIJMF /PSUI "NFSJDBO DFOUFST QSFEPNJ-

#POF-FWFM4-"DUJWFJNQMBOUTJOEBJMZDMJOJ-

nantly used either immediate or late implant

DBM EFOUBM QSBDUJDF 5IF SFTVMUT EFNPO-

QMBDFNFOU BOE SFTQFDUJWFMZ




strated the excellent performance of these

in combination with transmucosal healing

implants in all indicated clinical situations.


 4JNJMBSMZ  MPBEJOH PG JNQMBOUT XBT

'SPNUIF JOTFSUFEJNQMBOUT BUPUBMPG

performed differently in the two regions.

JNQMBOUGBJMVSFTXFSFSFQPSUFEXJUIJOUIF

$POWFOUJPOBMMPBEJOHXBTTJHOJmDBOUMZNPSF

mSTUZFBSPGJNQMBOUQMBDFNFOU BOETVSWJWBM

QSFWBMFOU JO UIF &VSPQFBO DFOUFST UIBO UIF

was not documented for three additional

/PSUI "NFSJDBO DFOUFST  WT 




JNQMBOUT 5IFSFGPSF  B UPUBM PG  JNQMBOU

and immediate loading and restoration were

GBJMVSFT XFSF DPOTJEFSFE #BTFE PO UIF

TJHOJmDBOUMZ NPSF QSFWBMFOU JO UIF /PSUI

SFNBJOJOH  JNQMBOUT UIBU DPVME CF

"NFSJDBODFOUFST BOEWT

BTTFTTFE BU UIF ZFBS GPMMPXVQ  UIJT

BOE 
 )FODF  UIFSF NBZ CF UFOEFODZ

SFTVMUFE JO B DVNVMBUJWF TVSWJWBM SBUF PG

for European implantologists to rely on a

VOLUME 44t/6.#&37t+6-:"6(6452013



Q U I N T E S S E N C E I N T E R N AT I O N A L
Fi l i p p i e t a l

NPSF DPOWFOUJPOBM QSPDFEVSF  XIJMF /PSUI

TMJHIUMZ NPSF UIBO  PG UIF DBTFT  TVH-

"NFSJDBOJNQMBOUPMPHJTUTGBWPSBNPSFDPO-

gesting

EFOTFE QSPDFEVSF 5IF NPUJWBUJPO GPS UIF

hygiene was a far more frequent factor for

EJGGFSFOU QSPDFEVSFT XBT OPU FWBMVBUFE JO

UPPUIMPTTJOUIJTTUVEZ4JNJMBSMZ UIFEJTUSJCV-

this study and potential clinical implications

tion of bone quality among the patients

therefore remain unclear. Unfortunately,

seeking implant treatment was assessed for

due to the heterogeneity of the data as a

UIF TJUFTXIFSFJNQMBOUTXFSFQMBDFE

SFTVMU PG UIF OPOJOUFSWFOUJPOBM OBUVSF PG UIF

5IJT SFWFBMFE UIBU UIF NBKPSJUZ PG JNQMBOUT

TUVEZ FH  MBDL PG EFmOFE JODMVTJPOFYDMV-

XFSF QMBDFE JO CPOF RVBMJUZ UZQF  PS 

TJPODSJUFSJB
JUXBTOPUQPTTJCMFUPQFSGPSN

  5BCMF
 #POF RVBMJUZ UZQF  PS 

a differential analysis of the outcomes of the

was rarely documented, which is in accor-

SFTQFDUJWF TVSHJDBM QSPUPDPMT BDDPSEJOH UP

dance with other assessments of the bone

SFHJPO 4VDI BO BOBMZTJT XPVME SFRVJSF B

quality distribution.5IFTFWBMVFTSFnFDUUIF

controlled clinical trial with all other param-

general situation in patients seeking implant

FUFST FH  QBUJFOU EFNPHSBQIJDT  JOEJDB-

treatment, thereby conrming that the cur-

UJPOT
FRVBMJ[FE BOEXBTPCWJPVTMZPVUTJEF

SFOU OPOJOUFSWFOUJPOBM TUVEZ SFQSFTFOUT UIF

the scope of the present study.

real-world scenario of daily dental practice.

5IF SFTVMUT PG UIF QSFTFOU TUVEZ TIPXFE

that

noncompliance

with

oral

5IF DVSSFOU TUVEZ JT POF PG POMZ B GFX

that the majority of implants showed no

TVDI OPOJOUFSWFOUJPOBM TUVEJFT JO EFOUBM

DIBOHF JO DSFTUBM CPOF MFWFM VQ UP  ZFBS 

implantology. In contrast, controlled clinical

XJUIMFTTUIBOPGJNQMBOUTTIPXJOHDSFTUBM

USJBMT IBWF TUSJDUMZ EFmOFE QBUJFOU JODMVTJPO

CPOFMPTTPGHSFBUFSUIBONN5IJTBQQFBST

and exclusion criteria and are often per-

to mirror the results from a recent clinical

formed under highly controlled conditions,

TUVEZ JO  QBUJFOUT XJUI 4USBVNBOO #POF

which can increase the likelihood of more

-FWFM JNQMBOUT JO UIF BOUFSJPS NBYJMMB BOE

GBWPSBCMFPVUDPNFT-BSHFSUSJBMTUFOEUPCF

mandible. 4JNJMBS DMJOJDBM PVUDPNFT XJUI

in the form of cohort studies, which can be

both submerged and transmucosal healing

QSPTQFDUJWFPSSFUSPTQFDUJWF5IFTFVTVBMMZ

and a minimal mean change in crestal bone

JOWPMWFQBUJFOUTXIPTIBSFBDPNNPOEFO-

MFWFM PG NN NN BOE NN

UBM TJUVBUJPO FH  SFRVJSJOH JNQMBOUT UP

for submerged and transmucosal implants,

replace hopeless teeth,QBUJFOUTSFDFJWJOH

SFTQFDUJWFMZ
 XFSF PCTFSWFE PWFS 

a similar prosthesis,  SFRVJSJOH WFSUJDBM

months.  .PSFPWFS  HPPE FTUIFUJD SFTVMUT

augmentation, SFDFJWJOH TIPSU JNQMBOUT JO

XJUIUIF4USBVNBOO#POF-FWFMJNQMBOUIBWF

posterior jaws, periodontally compromised



CFFO EFNPOTUSBUFE JO B QSPTQFDUJWF DBTF

patients,  edentulous mandible,  and

TFSJFT DPOEVDUFE PWFS B NPOUI QFSJPE

sinus augmentation
 5IF BEWBOUBHF PG B

5IFTFSFTVMUTSFNBJOFETUBCMFVQUPZFBST 

OPOJOUFSWFOUJPOBM TUVEZ JT UIBU UIF QFSGPS-

at which time the mean bone loss was

mance of a product, technique, or treatment

NN 5IF MJNJUFE CPOF MPTT GPS UIF

DBO CF JOWFTUJHBUFE VOEFS DPOEJUJPOT UIBU

4USBVNBOO #POF -FWFM JNQMBOU NBZ CF

NJSSPS UIPTF UZQJDBMMZ TFFO JO QSJWBUF QSBD-

related to its platform switch, which has been

tice settings.

corroborated by preclinical studies compar-

One drawback of such large prospec-

ing this design for both submerged and

UJWFMPOHJUVEJOBMTUVEJFT IPXFWFS JTUIBUUIF

transmucosal healing approaches. 

patient attrition rate may be much higher

%VF UP UIF MBSHF OVNCFS PG FOSPMMFE

than with controlled clinical trials. Most of

QBUJFOUTBOEJNQMBOUT UIJTOPOJOUFSWFOUJPOBM

this is due to patients being lost to follow-

TUVEZ NBZ BMTP TFSWF BT B TVSWFZ  FH UP

VQ FHEVFUPGBDUPSTTVDIBTQBUJFOUTNPW-

assess potential reasons why patients lose

ing away or changing their dentist, not

teeth and subsequently request implant

BUUFOEJOH TDIFEVMFE WJTJUT  OPU CFJOH DPO-

USFBUNFOU 'SPN UIF  FOSPMMFE QBUJFOUT 

tactable by the clinician, referrals to other

NPSFUIBOPGUIFSFDPSEFEUPPUIMPTTFT

DMJOJDJBOT FH  GPS QSPTUIFUJD XPSL


 PS GPS

XFSFEVFUPQFSJPEPOUJUJTPSDBSJFT 5BCMF


other reasons. In other cases, there may be

5IFTFWBMVFTXFSFTJNJMBSUPUIFSFBTPOTGPS

data missing despite the patient attending

UPPUIMPTTSFQPSUFEQSFWJPVTMZ In contrast,

GPSUIFTDIFEVMFEWJTJU EVFUPJODPOTJTUFOU

tooth fracture or trauma was the reason for

JODPNQMFUF EBUB FOUSZ UIJT JT LOPXO UP CF



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Q U I N T E S S E N C E I N T E R N AT I O N A L
Fi l i p p i e t a l

more common for secondary parameters,


as the focus is often on the primary outcome. 5IF SBUF PG BUUSJUJPO JO UIF QSFTFOU
TUVEZ XBT KVTU PWFS  *U IBT CFFO TVHHFTUFE UIBU BUUSJUJPO PG  PS HSFBUFS NBZ
raise concerns about the possibility of bias
JOSBOEPNJ[FEDPOUSPMMFEUSJBMT  especially
if there is a high rate of loss to follow-up in

ny). The authors would also like to acknowledge Dr


Simone Schilling (Landshut Nikola, Germany) for her
extensive work in the documentation of cases. Clinicians
did not receive funding for the administration of the
study, but received a nominal payment based on the
provision of complete documentation for each patient
(ie, funding was on a per-case basis). With the exception
of this, the authors report no conicts of interest associated with the organization of the study.

BQBSUJDVMBSHSPVQPGQBUJFOUTIPXFWFS EVF
to the large number of patients and the
greater heterogeneity of patients and indiDBUJPOT JO B MBSHF OPOJOUFSWFOUJPOBM USJBM

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