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Immediately loaded CAD-CAM

manufactured fixed complete


dentures using flapless implant
placement procedures: A cohort
study of consecutive patients
Anna M. Sanna, DDS,a Liene Molly, DDS, PhD,b and
Daniel van Steenberghe, MD, PhDc
Catholic University Leuven, Leuven, Belgium
Statement of problem. Data available regarding the treatment outcome for completely edentulous jaws by means of
a prefabricated fixed complete denture placed immediately after flapless implant insertion using a surgical guide are
only short term.
Purpose. The purpose of this study was to follow the survival of implants inserted in completely edentulous jaws using
a flapless procedure and immediately loaded with prefabricated fixed complete dentures for several years. A second
purpose was to investigate whether there is a difference in marginal bone remodeling in smoking (S) and nonsmoking
(NS) patients.
Material and methods. During a 5-year period (mean time of follow-up 2.2 years), 30 consecutive patients, 12 women, 38-74 years of age (average 56 years) were treated for complete edentulism in 1 arch in the Department of Periodontology at the University Hospitals in Leuven. The S group included 13 and the NS group 17 patients. Descriptive
statistics were used to analyze the data. Two outcome parameters were analyzed: the cumulative survival rate (CSR) of
individual implants and the marginal bone remodeling for up to 5 years in the 2 groups.
Results. Nine (4.9%) implants failed. Eight of the failures occurred in 3 smoking patients. The absolute survival rate
for all patients was 95%, while the cumulative survival rate (CSR) after 5 years was 91.5%. For the NS group, the CSR
was 98.9%, while for the S it was 81.2%. The mean marginal bone resorption was - 2.6 and - 1.2 mm in the S and NS
groups, respectively.
Conclusions. The present findings indicate that the treatment protocol described results in good implant survival rate
even after several years. Smoking may eventually compromise the efficacy of this treatment concept. (J Prosthet Dent
2007; 97: 331-339)

Clinical Implications

The high success rate achieved for nonsmoking patients (99%


survival after 5 years) in the rehabilitation of complete edentulism makes this flapless surgical approach a valid treatment
alternative.
Data available concerning completely edentulous jaws rehabilitated
by means of flapless implant surgery,
using a customized prefabricated surgical guide and an immediate loading
protocol, are only short term.1 With

the 2-stage approach in the symphyseal area, a 99% implant success rate
has been reported after 15 years.2 Success seems to depend on the implant
type, since relatively poor success
rates have been reported for some im-

This research was partially financed by Nobel Biocare.


Senior Assistant, Oral Surgeon, Department of Periodontology.
Assistant Professor, Department of Periodontology.
c
Full Professor; Department Head; Holder of the PI Branemark Chair in Osseointegration.
a

Sanna et al

plant surfaces and geometries placed


in similar anatomical areas.3,4 Over
the last decade, however, some reports have been published indicating
that early (within 2 weeks) and even
immediate (the same or the next day)

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Volume 97 Issue 6
occlusal loading of implants may also
result in high survival rates.5,6
The present report exclusively
describes immediate loading of implants in completely edentulous jaws.
When immediate loading of implants
is used, roughened implant surfaces
show a better survival rate (99%)
when compared to those with machined surfaces (83%).7-9 Comparative
studies, using implants with so-called
modified surfaces, which means the
achievement of a roughened surface
with techniques such as oxidizing, do
not demonstrate significant differences between immediate and delayed
loading.10
A major concern for successful
osseointegration is the limitation of
relative implant movement. Micro
movements up to a certain level (150
m) do not seem to interfere with
bone apposition.11 This limitation
was achieved in the present study by
placing a rigid fixed prosthesis immediately after surgery, by using expanding abutments, which fit perfectly
within the holes of the prosthesis.
The abutments are expanded when
the screws are tightened and, thus,
retain the fixed complete denture. It
has been shown that immediate loading of dental implants is compatible
with predictable osseointegration, if a
proper implant surface texture is used
and rigid splinting is obtained by using a prosthesis.7 A recent meta analysis revealed no difference in survival
rate when immediate loading was
compared to delayed loading protocols.12 This is in contradiction with
previously published reports that indicated that the survival rate for immediate loading was only slightly but
significantly lower than delayed loading protocols.13,14
In the present study, a treatment
protocol was used which achieves immediate rigid splinting by means of a
prefabricated fixed complete denture
consisting of a metal framework and
acrylic resin. This treatment concept
was developed in Leuven, Belgium during the mid-nineties. It was reported
in several publications, as LITORIM,

an acronym for Leuven Information


Technology-based Oral Rehabilitation by means of Implants. It has been
marketed since 2005 as Teeth-in-anHour (Nobel Biocare AB, Goteborg,
Sweden). Since the techniques involved have been described in detail
in a series of publications, they will be
only briefly described in the Material
and Methods section.15-17
The principal aim of this study
was to verify whether the previously
reported short-term survival data1
of flapless surgery for this treatment
concept would still apply after several
years and whether the marginal bone
level would remain stable. The study
also verified, in this patient cohort,
whether smoking would influence the
outcome variables.

MATERIAL AND METHODS


All patients with at least 1 completely edentulous arch who sought
rehabilitation with an implant-supported fixed complete denture were
considered as possible candidates.
The decision for immediate loading
of implants, inserted by flapless surgery, using a prefabricated metal and
acrylic resin fixed complete denture
was made on the basis of medical (to
interrupt anticoagulant therapy only
once), psychological (fear of surgery),
and social (significant scheduling
constraints) considerations but with
3 exclusion criteria. These exclusion
criteria were radiotherapy in the maxillary region, lack of a usable jawbone
height of at least 10 mm, or presence of serious undercuts in the bone
anatomy. There was no limitation on
the basis of medically compromising
conditions such as anticoagulants, bblocking agents, hypertension, hypothyroidism, or smoking. After obtaining a patient history, including both
the general medical and specific oral
history, each patient was thoroughly
informed about the procedure. Since
the collection of data of these patients
was part of routine clinical practice
and did not influence by any means
the therapeutic choice, the authors

The Journal of Prosthetic Dentistry

were not required to obtain institutional review board approval for the
use of human subjects in this study.
During a 5-year period (mean time
of follow-up, 2.2 years), 30 patients
with a completely edentulous jaw and
who had problems with their complete
dentures were consecutively treated in
the Department of Periodontology of
the University Hospitals of the Catholic University of Leuven using implants
with an oxidized surface (TiUnite
Branemark System; Nobel Biocare
AB). Subject age varied between 38
and 74 years with a mean of 56 years.
The S group included 13 smoking patients (43.3 %). Smoking was defined
as smoking more than 10 cigarettes
per day. The NS group included 17
nonsmoking patients. Four of the 30
patients (13.3 %) were treated in the
mandible.
Initially, the patients were referred
back to their personal dentist or to
the Department of Prosthetic Dentistry at Leuven University Hospitals
for the fabrication of a radiolucent
scan template made of heat-polymerized acrylic resin (Auto Plas; Candulor, Wangen Switzerland) with a tooth
arrangement mimicking the planned
fixed prosthesis. At least 6 gutta percha (Gutta percha Points ISO Sizes,
Colored; Dentsply DeTrey GmbH,
Konstanz, Germany) or provisional
restorative material (Cavit; Kerr Corp,
Orange, Calif ) markers were included
in the scan template in different axial
planes to serve as radio-opaque references. An interocclusal index consisting of autopolymerizing acrylic resin
(Vertex-Trayplast; Oudheusden Dental, Ziest, The Netherlands) was also
made to allow reproducible placement of the scan template intraorally
by having the patient gently occlude
against it. The same interocclusal index was later used to position the surgical guide in a similar position during
surgery, thus, ensuring a proper transfer of the planned surgical locations
and orientations. The patient was then
referred to the Department of Radiology at Leuven University Hospitals
for a high-resolution spiral computed

Sanna et al

333

June 2007
tomography (CT) (Somatom Volume
Zoom; Siemens, Erlanger, Germany)
scan. A double scanning procedure
was followed. The first CT scan, with
the subject wearing the radiographic
scan template and interocclusal index, was used to visualize the bony
architecture and anatomy of the site
of interest. A second CT of the scan
template alone was performed using different CT scanner settings to
visualize the nonradioopaque radiographic guide. The 2 resulting sets of
Digital Imaging and Communication
in Medicine (DICOM) files were then

fused by making the radioopaque


gutta percha markers coincide. The
2 resulting sets of DICOM files were
fused on the basis of the presence of
radio opaque gutta percha markers.
Surface representations of the
bone and the prosthesis were computed from these CT data sets by
means of segmentation and loaded
into a 3-dimensional (3-D) imagebased treatment planning software
(Procera software; Nobel Biocare
AB). The software allows for simultaneous observation of both arches and
the radiographic scan template in 3

spatial planes. The clinician can either


observe the entire scene or 1 plane
only. It is also possible to hide an object, for example, the bone or the scan
template, or both (Fig. 1).
The clinician can interactively manipulate a curve in the 3-D viewer to
determine the plane for the reslices,
which are planes oriented perpendicularly along the bony crest (Fig. 2).
The split-screen mode on the computer also allows viewing the reslices on
which the virtual implant insertion
is performed. Placing an implant is
accomplished as during surgery, by

1 Virtual display indicates objects that are relevant for implant treatment planning. A, Bone, planned prosthesis, and
implant axes are visualized. B, Depending on details to be examined, prosthesis can be temporarily hidden.

2 General overview of maxilla illustrating 3-D images. A, Spline curve (green curve) following maxillary crest is clearly
visible. B, Reslice viewer provides access to image data for initial positioning of implant.

Sanna et al

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Volume 97 Issue 6
indicating a point on top of the alveolar crest and a second point more
apically located, thus, mimicking the
drilling procedure. The surgeon can
change the implant dimensions, position, and inclination at any time.
Every change in 1 view concomitantly
appears in all viewer planes since they
are fully related views of the same
object. The program indicates the
minimal distances to be respected in
between implants as a security zone
of 1 mm around implants. The surgeon also plans 3 horizontal stabilizing pins to fix the surgical guide to the
jawbone. They are located in between
the planned implants. Once the planning is verified and confirmed by the
clinician, it is sent to the computer
assisted design computer assisted
manufacturing (CAD-CAM) facility
(Procera; Nobel Biocare AB) to manufacture both the surgical guide and
prefabricate the milled titanium prosthetic framework.
All surgeries were performed under local and regional anesthesia with
the patient lying in a supine position
on the table and with strict asepsis.
Sterile gowns and drapes were used,
as well as preoperative disinfection
of the oro-pharynx including rinsing
with a 0.1% chlorhexidine solution
(Perio Aid; Dentaid Benelux, Houten,
The Netherlands) solution just prior
to surgery. A perforated nose cap was
used to avoid contamination of the
gloves and instruments.18 Two surgical suction devices, 1 for the mouth
and 1 for the surgical fields, were
available to avoid bacterial cross contamination by means of saliva.
The surgery started by fixing the
surgical guide to the dental arch by
means of 3 transalveolar pins (Nobel
Biocare AB). To ensure proper positioning of the guide, the interocclusal
index was used, and the patient was
asked to clench gently. The acrylic
resin surgical guide contained metal
cylinders that, in turn, held removable
sleeves. The latter had different diameters to coincide with the drills used
to prepare the implants sites (Fig. 3).
The gingival surface of the surgi-

cal guide was removed through the


holes by using a special drill (Nobel
Biocare AB). After using the series of
drills to prepare 1 hole on each side
of the jaw, the predetermined implant
(Nobel Biocare AB) was inserted
through the appropriate cylinder. Stability was further improved by inserting an expanding abutment (Procera;
Nobel Biocare AB) on top of these 2
implants, 1 at each side of the dental
arch (Fig. 4). When limited bone resistance was noted by tactile assessment
during drilling, undersized drilling of
the alveolus was performed prior to
implant insertion to achieve a better
primary stability by compressing the
trabecular bone.
Once all implants were inserted
(Fig. 5) the CAD-CAM fabricated
metal and acrylic resin complete
fixed denture was connected to the
implants by means of the expanding
abutments (Fig. 6). The latter consist
of titanium cylinders in the coronal

half, which fits into the metal cylinders of the prosthesis, and expand
when the fixating screws are tightened. Thus, through friction between
the outer part of the expanding abutment and these cylinders, the prosthesis is tightly fixed. The unavoidable
small deviation between the planned
implant position and axis (a fraction
of a mm and a few degrees) and the
postoperative position is compensated by a small space between the
abutments and the cylinders within
the prosthesis.17 The apical half of
the abutment, which pierces through
the gingival or alveolar mucosa on the
other hand, is a full cylinder which
prevents bacterial ingrowth. A panoramic radiograph or serial intraoral
radiographs were immediately made
to evaluate the proper adaptation of
all abutments to the shoulders of the
implants (Fig. 7). Once this was successfully confirmed, the abutments
were tightened to 35 Ncm. The screw

3 Three stabilizing transalveolar pins fix surgical guide through gingival


tissues into bone.

4 Surgical template with metal sleeves used for accurate implant


orientation.

The Journal of Prosthetic Dentistry

Sanna et al

335

June 2007

5 A, Preparation of alveolus. B, Implant placement, using surgical template with inserted sleeves.

B
A
6 A, Metal and resin fixed complete denture with expanding abutments inserted. B, Frontal view of fixed complete
denture immediately after surgery.

7 Panoramic radiograph illustrating complete rehabilitation with prefabricated titanium implant denture supported by 8 implants.

Sanna et al

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Volume 97 Issue 6
bone level at years was measured by
a periodontologist in both groups (S
and NS), whenever available. On the
digital panoramic radiographs, the
bone level was assessed both mesially
and distally of each implant. Since
the distance between 2 threads is always 0.6 mm the latter functioned as
an internal standard. The discrimination power can be assured up to half
a thread, thus, corresponding to 0.3
mm.19 The mean and standard deviation (SD) of the marginal bone level
were calculated.
Data were analyzed using descriptive statistics. The marginal bone
remodeling, the number implants
placed, number of implants lost,
their diameters and survival time
were recorded. The absolute and cumulative survival rates were calculated using the following formula:
1- [ ( N C F R = P C F R + ( I F R ( ( 1 0 0 PCFR)/100))] where NCFR is the new
cumulative failure rate; PCFR is the
previous cumulative failure rate; and
IFR is the interval failure rate (failed
implant during interval/number implants present at the beginning of
that interval).

access openings of the prosthesis


were filled with gutta percha (Gutta
percha; Dentsply DeTrey GmbH).
Patients received 500 or 1000 mg
of paracetamol (Panadol; GlaxoSmithKline, Genval Belgium) at the end
of surgery and were instructed to use
the analgesic, 4 to 6 times a day for as
long as necessary. Patients were also
instructed to use a chlorexidine rinse
(Perio Aid; Dentaid, Benelux, Houten,
The Netherlands) twice a day. Patients were placed on a soft diet during the first 2 months after surgery
to limit occlusal loading and reduce
micromovement, which are known to
interfere with osseointegration.
All 30 patients were recalled after
1 day, 2 days, 3 months, and subsequently, annually. Four patients
were lost to follow-up (after 1 year)
because they moved to another city/
country or could not be convinced
of the need for further evaluation. At
each visit, oral hygiene methods were
reinforced. Panoramic radiographs
were made at annual recalls. The
presence of eventual radiolucencies,
indicative of a fibrous encapsulation
surrounding the implants, was noted.
The patient records were retrospectively analyzed. The marginal

RESULTS
Patients were followed up to a 5year period with a mean follow-up
time of 2.2 years. In 30 consecutive
patients, a total of 212 implants were
placed. The implant lengths varied
between 8.5 and 15 mm and implant diameters were 3.75 (n= 201),
4 (n=3), or 5 mm (n=8). Four patients
(29 implants) did not return for further evaluation after initial treatment
completion. Thus data for the remaining 26 patients for a total of 183 implants were analyzed. However, when
reached by phone all 4 patients confirmed that they had a properly functioning fixed denture. Only 9 (4.9%)
implants, out of these 183, were lost,
8 of them in patients from the smoking
group. The ninth implant was placed
in a subject with no identifiable local or systemic compromising factor.
The absolute survival rate for the entire patient group was 95% while the
cumulative survival rate (CSR) after
5 years 91.5% (Table I). The CSR was
98.9% and 81.2% for the NS (Table II)
and S groups, respectively (Table III).
The mean bone loss was 2.6 mm and
1.2 mm for the S and NS groups, respectively (Fig. 8). The distributions
can be found in Tables IV and V.

Table I. Cumulative survival rate (CSR) for entire sample with up to 5 years of follow-up
Follow-up
(Months)

Number of
Patients

Number of
Implants

Number of
Failing Implants

Cumulative
Survival Rate (%)

0-6

30

212

100

6-12

28

199

100

12-18

24

172

98.7

18-24

14

103

95.9

24-30

13

92

94.8

30-36

12

85

91.5

36-42

10

67

91.5

42-48

39

91.5

48-54

15

91.5

54-60

91.5

60-66

91.5

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Sanna et al

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June 2007

Table II. Cumulative survival rate (CSR) in nonsmoking group with up to 5 years of follow-up
Follow-up
(Months)

Number of
Patients

Number of
Implants

Number of
Failing Implants

Cumulative
Survival Rate (%)

0-6

17

119

100

6-12

16

114

100

12-18

13

93

98.9

18-24

59

98.9

24-30

51

98.9

30-36

45

98.9

36-42

30

98.9

42-48

14

98.9

48-54

98.9

54-60

98.9

60-66

98.9

Table III. Cumulative survival rate (CSR) in smoking group with up to 5 years of follow-up

Sanna et al

Follow-up
(Months)

Number of
Patients

Number of
Implants

Number of
Failing Implants

Cumulative
Survival Rate (%)

0-6

13

96

100

6-12

12

83

100

12-18

11

83

97.7

18-24

68

90.6

24-30

68

88.3

30-36

67

81.2

36-42

60

81.2

42-48

28

81.2

48-54

12

81.2

54-60

--

--

--

--

60-66

--

--

--

--

338
Bone Level (mm)

Volume 97 Issue 6
0.5
0.0
0.5

81
113

Nonsmoking
Smoking
112

59
45

1.0
71

1.5

43

2.0

40

2.5
3.0

22

25
0

Year

8 Marginal bone level for smoking and nonsmoking patients. Figures reveal number of implants observed.

Table IV. Mean marginal bone levels and standard deviations at different time points during
follow-up in smoking patients

Table V. Mean marginal bone level and standard deviations at different time points during
follow-up in nonsmoking patients

Time
Period

Number of
Implants

Mean
(mm)

SD
(mm)

Time
Period

Number of
Implants

Mean
(mm)

SD
(mm)

Baseline

81

0.1

0.4

Baseline

113

0.1

0.5

1 year

71

-1.1

1.4

1 year

112

-0.8

1.1

2 year

43

-1.6

1.6

2 year

59

-0.8

1.2

3 year

40

-2.0

1.6

3 year

45

-1.2

1.1

4 year

25

-2.6

1.6

4 year

14

-1.3

1.0

5 year

-1.2

0.8

DISCUSSION
Immediate loading seems to be a
reasonable alternative to the classical, 2-stage, thoroughly documented
protocol. In the present study, a key
element to success may be the immediate and rigid connection of the
implants by using an acrylic resin and
metal fixed complete denture. When
excess micromovement occurs, stem
cells in the osseous wound differentiate to fibroblasts to form scar tissue
around the implant inhibiting osseointegration.11
The present study reports medium
term observations in which the stability of the marginal bone level over
such a period is reassuring.
The present high cumulative sur-

vival rate for the rehabilitation by


means of implant-supported fixed
dentures of the completely edentulous maxillary arch, known to lead
to less favorable outcomes than in
the mandible,20 indicates the high
predictability of this concept. When
smoking patients were excluded, the
CSR reached 99%. The significant
lower CSR in smoking patients should
result in a provisional reappraisal for
the use of such an immediate loading
concept in this type of subject. However, larger series should be investigated before this can be ascertained.
The present data indeed contradict
anecdotal reports, which have shown
that immediately loaded implants can
be successful in heavy smokers.21,22
Other systemic factors could not be

The Journal of Prosthetic Dentistry

investigated since the present series


was small and the incidence of such
factors low.
Studies with more rigorous selection criteria, thus excluding the known
risk factors such as smoking, demonstrate results with 1-stage early or immediate loading protocols that are
similar to conventional 2-stage procedures.23,24 The influence of smoking
on osseointegrated implants, even
with delayed loading, is well established.25 There is a need for a larger
and prospective study to confirm the
impact of smoking and eventual other
systemic or local factors on the treatment outcome of immediately loaded
implants placed using a flapless procedure.

Sanna et al

339

June 2007
CONCLUSIONS
The use of a prefabricated custom-fit fixed complete denture supported by implants for the completely
edentulous patient over 5 years demonstrated similar results for the same
implant-supported prosthetic treatment but with delayed loading. Smoking may reduce the favorable outcome
but the limited series reported requires further confirmation.

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Reprint requests to:
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be
Acknowledgments
The authors thank all referring dentists
especially from the Department of Prosthetic
Dentistry, who performed the prosthetic treatment of the patients. We also thank Dr Matts
Andersson and Izidor Brajnovic of Nobel
Biocare for their assistance.
0022-3913/$32.00
Copyright 2007 by the Editorial Council of
The Journal of Prosthetic Dentistry.