five-year clinical trial using three attachment systems for implant overdentures
TRANSCRIPT
Corina Marilena CristacheLigia Adriana StancaMuntianuMihai BurlibasaAndreea Cristiana Didilescu
Five-year clinical trial using threeattachment systems for implantoverdentures
Authors’ affiliations:Corina Marilena Cristache, Concordia Dent Clinic,Bucharest, RomaniaLigia Adriana Stanca Muntianu, RemovableProsthodontics, Faculty of Dental Medicine,University of Medicine and Pharmacy “CarolDavila”, Bucharest, RomaniaCorina Marilena Cristache, Mihai Burlibasa,Implantology, FMAM, University of Medicine andPharmacy “Carol Davila”, Bucharest, RomaniaAndreea Cristiana Didilescu, Department ofAnatomy, Faculty of Medicine and Pharmacy,“Dunarea de Jos” University, Galati, RomaniaAndreea Cristiana Didilescu, Department ofEmbryology, Faculty of Dental Medicine,University of Medicine and Pharmacy “CarolDavila”, Bucharest, Romania
Corresponding author:Andreea Cristiana Didilescu8, Blvd Eroilor Sanitari, 050474, Bucharest,RomaniaTel.: +40 722536798Fax: +40 21 3131298e-mail: [email protected]
Key words: complications, costs, locator, magnet, prosthetic maintenance, retentive anchor
Abstract
Objective: The objective is to compare, in a prospective randomized clinical trial, three types of
attachment systems for mandibular implant overdenture, focusing on costs, maintenance
requirements and complications from baseline to the end of 5-year follow-up period.
Materials and Methods: Sixty-nine fully mandibular and fully/partially maxillary edentulous
patients received two screw-type Straumann implants, in the mandibular canine region. New
overdentures with three types of attachment systems were inserted according to an early-loading
protocol: Group B (balls, divided into Subgroup B.1 – retentive anchor with gold matrix and
Subgroup B.2 – retentive anchor with titanium matrix) (n = 23), Group M (magnets) (n = 23) and
Group L (locator) (n = 23).
Results: The highest maintenance event number (195) was observed in Group B vs. 31 in Group L
and 15 in Group M. Significantly more complications were recorded in Subgroup B.1 than in
Subgroup B.2, Group M and Group L (P < 0.05). Group M registered the highest prosthetic success
(82.6%) in the 5 years, followed by Group L (78.2%). Subgroup B.1 had the lowest success rate
(50%). The magnet group recorded statistically significant higher costs, comparing with the other
two groups (P < 0.05).
Conclusions: The three attachment systems functioned well after 5 years. The magnets had a low
maintenance requirement and high success rate, despite the relatively increased initial costs.
Retentive anchor with titanium matrix and locator may be a better choice from a financial point of
view, taking into consideration the initial low cost of the components and also the reduced
number of complications.
In case of the edentulous patients, the suc-
cess of the denture therapy depends upon the
biomechanical prodigy of support, stability
and retention (Jacobson & Krol 1983b,c). The
mandibular denture generally presents the
major problem with regard to retention due
to a movable floor of the mouth, which
causes difficulty in establishing a lingual
border seal. Denture stability is minimised
by lack of ideal ridge height and conforma-
tion (Jacobson & Krol 1983a). Due to resorp-
tion, the remaining anatomic regions of the
mandible are not usually essential in provid-
ing dental support (Jacobson & Krol 1983c).
Problems regarding integrating dentures
are observed with a higher incidence for
mandibular than for maxillary dentures
(Mericske-Stern 1998). To overcome these
drawbacks, over the past 35 years, clinicians
have been restoring aesthetics and function in
edentulous patients with implant overdentures
using different retention systems and nowa-
days the cost-effectiveness and the simplic-
ity of treatment become the main issues for
the choice of treatment (Zitzmann et al.
2006). The role of the attachment type is
very important (Kimoto et al. 2009): a rigid
connection between implants and denture
induces stress with potential implant failure
(Menicucci et al. 2006), especially when
hinge movements around the fulcrum line
occurs. Moreover, splinting implants by
means of a bar-clip construction is more
expensive, time-consuming, involves more
complications (Gotfredsen & Holm 2000)
and offers no marked differences in patient
satisfaction when compared with non-splint-
ing attachments (Cune et al. 2010). Due to
these facts, resilient and magnetic attach-
ment for implant overdentures, allowing
several types of movements, are extensively
used. The magnetic anchor is a non-rigid,
Date:Accepted 30 October 2012
To cite this article:Cristache CM, Muntianu LAS, Burlibasa M, Didilescu AC.Five-year clinical trial using three attachment systems forimplant overdentures.Clin. Oral Impl. Res. 25, 2014, e171–e178doi: 10.1111/clr.12086
© 2012 John Wiley & Sons A/S. e171
dynamic anchor. The retentive unit permits
rotary movement of the denture in one or
more directions and/or vertical translational
movements. The magnetic attachment den-
ture has a low resistance to lateral forces,
and the subsequent immediate loss of reten-
tion is associated with a lower level of
implant moment loading, thereby protecting
the implant against unfavourable lateral
forces (Heckmann et al. 2001). The desire
to use the magnetic retention is related to
the simplicity involving minimal time at
the chairside and in the laboratory. Two
different types of alloys were used for the
manufacture of small dental magnets:
cobalt-samarium magnets introduced in the
sixties and an alloy based on iron – neo-
dymium – boron in the eighties, both with
high attractive forces but with a low corro-
sion resistance (Walmsley 2005). Nowadays,
to increase corrosion resistance, the magnets
are encapsulated in stainless steel, titanium
or palladium by using laser-welded coatings
(Haruta et al. 2011).
As resilient anchors, balls (retentive anchors)
are considered the simplest and less costly type
of attachments for clinical application (Cakarer
et al. 2011).
The self-aligning locator system has dual
retention: through both external and internal
mating surfaces, is resilient, retentive and
durable, and has some built-in angulation
compensation (Cakarer et al. 2011). The loca-
tor system has been widely used in the past
three to 4 years, but there is a need of long-
term prospective clinical studies to compare
this system with other attachment systems
(Alsabeeha et al. 2011), particularly with
regard to the treatment’s success, as well as
clinical and prosthetic complications.
Although the recommended number of
implant is established (Feine et al. 2002), no
scientific data to support the use of one
attachment system against another are avail-
able for the edentulous mandible, due to the
fact that functional demands of edentulous
patients are highly variable and the choice of
treatment is strongly influenced by adaptive
capacity, socio-cultural background and also
by financial means (Fitzpatrick 2006).
Therefore, the aim of this study was to com-
pare three types of unsplinted attachment
systems, focusing on costs, maintenance require-
ments and complications, in a prospective clini-
cal trial: retentive anchors (balls, Straumann,
Basel, Switzerland), magnets (Titanmagnetics®
Steco system-technick, Hamburg, Germany) and
locator® (Zest Anchors, Inc., Escondido, CA,
USA), for implant overdenture in the edentulous
mandible. No differences between the attach-
ment systems regarding costs and maintenance
requirements defined the null hypothesis for-
mulated in the present study.
Materials and methods
The study was conducted from September 2004
to March 2012 according to the CONSORT
guidelines for improving the quality of clinical
trials (Altman et al. 2001; Moher et al. 2003;
Schulz et al. 2010) (Data S1). The use of human
subjects in this study was reviewed and
approved by the Romanian Ministry of Health
and written informed consent was obtained
from all participants.
Sixty-nine fully mandibular edentulous
patients (age ranging between 42 and 84 years)
were recruited from the University Hospital of
Dentistry and nine private practices in Bucha-
rest and the surrounding areas (ClinicalTri-
als.gov Identifier: NCT01034930). Their
maxillary status was as follows: 12 (17.4%)
with fixed bridges; 3 (4.3%) with natural teeth;
46 (66.7%) with removable complete dentures
and 8 (11.6%) with removable partial dentures.
The patients were selected based on all the fol-
lowing criteria: complains about the stability
of the existing mandibular denture satisfac-
tory from a technical point of view; patients
included in Class I to III (American College of
Prosthodontists Classification of Complete
Edentulism) (McGarry et al. 2004); acceptance
of a mandibular overdenture retained by two
endosseous implants; agreement for a 5-year
follow-up period.
Exclusion criteria comprised: insufficient
bone volume (height and width) for inserting
of at least a 10-mm implant (diameter 4.1)
(due to extensive residual ridge resorption,
patients in Class IV – American College of
Prosthodontists Classification of Complete E-
dentulism, were excluded); Angle class II rela-
tionship; physical condition that will affect
the minimal invasive surgical procedure or
constitute a hindrance for a 5-year follow-up
(e.g. immunosuppressive therapy, elderly
patients in poor physical condition); history of
radio-/chemotherapy in the head and neck
region; history of pre-prosthetic surgery
(including bone graft procedures) or previous
oral implants.
Selected patients were informed about the
three different treatment options and about
the benefit of treatment with an overdenture
retained by two endosseous implants (Feine
et al. 2002).
The medical status and dental history of
all patients were checked and an oral and
radiographic examination (including oral
hygiene status) was performed before any
treatment procedure.
Surgical procedure
Each patient received two screw-type Strau-
mann (Switzerland) standard soft tissue level
implants 4.1 mm diameter, with sandblasted
large-grit acid-etched (SLA) surface in the
canine region of the mandible with an inter-
connecting line approaching parallelism with
the terminal mandibular hinge axis (Naert
et al. 1998). The implant lengths were 10 or
12 mm. The choice of implant length was
dictated by the preoperative radiographic
assessment of bone height in the canine
region and drilling distance, with the princi-
pal concern of achieving primary stability.
Bone height in the canine region was
assessed on orthopantomograms. Jaw bone
quality was rated during the dental implant
surgery, by the tactile resistance during dril-
ling. The same surgeon for all the cases
performed the implant surgery, allowing an
objective evaluation.
Both clinical and radiographic evaluation
permitted a classification according to the
Lekholm & Zarb (1985) index.
The implants were inserted under local
anaesthesia in a one-stage non-submerged
procedure according to a strict protocol (Wein-
gart & ten Bruggenkate 2000).
Prosthodontic procedure
The mandibular denture was adjusted by
selective grinding at the implant location, Pro-
tefix® (Queisser Pharma, Hamburg, Germany).
Adhesive cushions were provided and patients
received oral hygiene instructions. One, two
and 4 weeks after the surgical procedure,
patients were recalled for follow-up visits. At
the third follow-up visit, the manufacturing of a
new maxillary denture (for the full maxillary
edentulous patients) and a new mandibular
overdenture with metal reinforcement were
initiated. For the maxillary dentate patients,
correct maxillary fixed rehabilitation was
performed prior to implant surgery at the man-
dible.
After 6-week healing period, implants were
loaded using an early-loading protocol (Apari-
cio et al. 2003; Morton 2008; Lethaus et al.
2011). A dental assistant, not involved in this
research project randomly assigned the
patients to one of the three main groups
(Table 1, Fig 1a–g):
1. Group B – (n = 23) received retentive
anchors (Straumann); it was randomly
divided into two subgroups (B.1: with
gold matrix and B.2: with titanium
e172 | Clin. Oral Impl. Res. 25, 2014 / 171–178 © 2012 John Wiley & Sons A/S.
Cristache et al �Different retentions for implant mandibular overdenture
matrix), based on characteristics of the
overdenture attachment.
2. Group M – (n = 23) received magnets
(Titanmagnetics® Steco system-technick.
3. Group L – (n = 23) received locator (Zest
Anchors, Inc).
The random assigning was done using 69
sequentially numbered opaque sealed enve-
lopes (SNOSE) according to the protocol
proposed by Doig & Simpson (2005), regard-
less of the state of the opposing maxilla.
The prosthetic procedure was performed by
experienced prosthodontists, according to the
recommendations of the manufacturer (Strau-
mann Dental Implant System) for retentive
anchors, magnets and the locator system.
Occlusion was assessed both on the articula-
tor and intra-orally to secure a balanced
occlusion in centric relation without anterior
tooth contact (Naert et al. 2004b; Vercruys-
sen et al. 2010).
Patients were scheduled for follow-up visits
at 1-week post-prosthesis insertion and every
6-month post-abutment insertion. At each
follow-up visit, patient received oral hygiene
care and written oral hygiene instructions.
Outcome measurements
Data collection was performed by two inde-
pendent researchers (without knowledge of
the prosthodontist) at baseline assessment
(1 week after insertion of the implant over-
denture) (T0), 6 months (T) and annually (T1–
T5).
Prosthetic maintenance and complications
(related to implant components, structure of
the prosthesis and adjustments of the prosthe-
sis including soft tissue problems) were
assessed from baseline until T5, according to
the number of scheduled (planned and routine
procedures) and unscheduled visits (solicited
by the patients). All the events were prospec-
tively documented using evidence-based crite-
ria from baseline to 5 years and the
prosthodontic success was assessed with the
aid of the six-field table analysis proposed by
Payne et al. (2001). According to this analysis,
the criteria are defined as follows:
Success – no evidence of retreatment except
for accepted maintenance (includes patrix
activation/repair/replacement, matrix acti-
vation/repair/replacement and asymptom-
atic periimplant/interabutment mucosal
enlargement not requiring excision). There
is a limit of two replacements of either pa-
trix or matrix in the first year and five
replacements in 5 years, and one reline of
the overdenture base in 5 years.
Survival – patient cannot be examined
directly, but the patient or another clinician
confirms no evidence of retreatment except
that described for a successful outcome.
Unknown (lost to follow-up) – patient
cannot be traced; surviving or successful
implant overdenture removed to allow —
to provision of a new overdenture, for
example, conversion to another overden-
ture design with additional implants or a
fixed implant prosthesis using the same
or additional implants.
Deceased – patient died during the study
period regardless of whether successful or
surviving criteria were experienced and
recorded before death.
Retreatment (repair) – Treatment of
implant overdenture and/or mucosa where
marginal integrity and associated patrices/
matrices are maintained irrespective of
modifications as long as it continues as an
implant overdenture. This includes more
than two replacements of either patrix or
matrix in the first year or more than five
replacements in the first 5 years. It also
includes replacement of worn or fractured
overdenture teeth/fractured overdentures,
relining of overdenture more than once in
5 years or excision of patrix-associated
mucosal enlargement as a result of infringe-
ment on the shoulder/undersurface of the
patrix.
Retreatment (replace) – part or all of implant
overdenture is no longer serviceable
because of either loss of implants or irrep-
arable mechanical breakdown.
The two subgroups of Group B were analy-
sed separately.
Cost analysis
Costs for each type of attachment were calcu-
lated according to all the procedures and com-
plications at first year (T1) and fifth year (T5)
and were subdivided into direct and indirect
costs, being estimated based on the minimal
clinical charges for the procedures by the sur-
geon, prosthodontist and dental hygienist.
The direct costs included costs of dental labo-
ratory, costs of materials (implants and com-
ponents), pharmaceuticals, radiography and
charges for the procedures by the clinician
and the dental laboratory. The indirect costs
included the patient’s time and out-of-pocket
expenses (Penrod & Takanashi 2003).
In our calculation, the direct costs were
considered. Aftercare was defined as care and
maintenance provided during the evaluation
period, including check ups and cleaning.
Costs of complications (components, prostho-
dontist and dental laboratory fees) were
considered separately.
The costs of dental implants and compo-
nents are from the Romanian Straumann rep-
resentative – February 2009. Costs of the
prosthetic complications per patient were
calculated in the following manner: total costs
of complications per group/subgroup divided
by n (i.e. number of patients in the group/
subgroup) = costs of prosthetic complications
per patient in the respective group/subgroup.
Assessment of implant failure
This was performed according to previously
established criteria (Albrektsson et al. 1986).
Statistical analysis
Data were expressed as mean values, stan-
dard deviations (SD), ranges, medians and
percentages, as appropriate. The Levene test
was used to verify the homogeneity of vari-
Table 1. Groups/subgroups divided upon characteristics of overdenture attachments
Group No. of patients Patrix MatrixRetentive force indicatedby the manufacturer Manufacturer for Straumann
B, Subgroup B.1 12 Retentive anchor abutment,height 3.4 mm, titanium
Gold matrix – Elitor Varied retention (fourlamellae functioninglike a spring)
Straumann, Basel,Switzerland
B, Subgroup B.2 11 Titanium matrix Spring with a definedextraction force: 700–1100 g
Straumann, Basel,Switzerland
M 23 Titanmagnetics insert,height 3.25 mm,titanium housing
Denturetitanmagnetics
Not specified by themanufacturer
Steco system-technick,Hamburg, Germany
L 23 Locator abutment 3 mm,titanium alloy
Denture cap titaniumwith nylon retention
Pink light retention1360 g
Zest Anchors, Inc.,Escondido, CA, USA
© 2012 John Wiley & Sons A/S. e173 | Clin. Oral Impl. Res. 25, 2014 / 171–178
Cristache et al �Different retentions for implant mandibular overdenture
ance. Associations were tested using Pearson
Chi-squared test and Fisher’s exact test.
Analysis of variance was used to test for sig-
nificant differences between means, and the
Scheffe post hoc test analysed the effects
through multiple comparisons. Non-paramet-
ric Kruskal–Wallis and Mann–Whitney U
(Wilcoxon)-tests were performed to compare
the medians between the groups/subgroups
considered. All tests of significance were
two-tailed. StataIC 11 statistical software
(StataCorp LP, College Station, TX, USA,
version 2009) was used for data analysis. A
P-value < 0.05 was considered statistically
significant.
Results
The results confirmed group homogeneity.
There was no statistical difference between
groups for age, bone height in the canine
region and interimplant distance (P > 0.05,
one-way ANOVA test). No association was
recorded between any group and bone qual-
ity, bone quantity, gender or implant length
(P > 0.05, Pearson Chi-squared and Fisher’s
exact tests). No significant difference was
recorded between groups in terms of period
of edentulism (P > 0.05, Kruskal–Wallis test).
Out of the 138 implants placed, four were
lost in three patients (two women and one
man, the last one, a heavy smoker lost both
implants), leading to 97.1% survival rate
during the healing phase (before loading). The
four failed implants (length of 12 mm) were
replaced and healed uneventfully. All patients
could be treated as previously planned with
mandibular two implants overdenture. No
patient dropped out from the study. A mean
number of 3.49 � 5.64 (range 0–21, median 1)
maintenance events in the 5-year period was
recorded for the entire cohort of patients
(n = 69). Table 2 shows the number of main-
tenance events for each group per year.
Baseline group analysis
The summary of the main findings per group
is shown in Table 3.
Occurrence of complications
A mechanical complication occurred in one
patient of Group M, during the fourth year of
the evaluation period: the screw of one of the
abutments was fractured and a part of the
screw was stuck inside the implant. The bro-
ken piece was removed with the aid of a
service set sent by Straumann. A new abut-
ment was inserted and, due to the fracture, a
new denture had to be made.
Significantly more complications were
recorded in Subgroup B.1 than in Subgroup
B.2, Group M and Group L, respectively
(P < 0.05, Kruskal–Wallis and Mann–Whitney
U-tests). The number of maintenance events
was 241 in 5 years, with the following distri-
bution: 195 were observed in Group B (184 in
Subgroup B.1 and 11 in Subgroup B.2), 31 in
Group L and 15 in Group M. All the patients
belonging to Subgroup B.1 required matrix
activation at 6 months up to 1 year. Among
them, four patients needed matrix replace-
ment (eight prosthetic components for two
implants) (Table 4). No statistical significant
differences were recorded between Subgroup
B.2, Group L and Group M (P > 0.05, Kruskal
–Wallis and Mann–Whitney U-tests).
Prosthodontic success
In our study, Group M registered the highest
prosthetic success (82.60%) in 5 years,
followed by Group L (78.26%). Subgroup B.1
had the lowest success rate (50%) (Table 5).
Cost analysis
The subgroups B.1 and B.2 recorded differences
in cost of prosthetic components at the same
surgical, prosthodontic and dental laboratory
fee (B.1 = 1594 Euro/patient and B.2 = 1670
Euro/patient).
Subgroup B.1 registered more expensive
first-year aftercare and complications per
(a) (b)
(d)
(c)
(e)
(f) (g)
Fig. 1. Implant overdenture attachment systems: (a) Group B – Retentive anchor abutments; (b) Subgroup B.1 – Gold
matrix with variable retention; (c) Subgroup B.2 – Titaniummatrix with defined retention; (d) Group M – Magnet abut-
ments; (e) Group M – Magnet denture insert; (f) Group L – Locator abutments; (g) Group L – Locator denture insert.
Table 2. The distribution of maintenance events per year
Group Year 1 Year 2 Year 3 Year 4 Year 5
BB1 31 26 35 48 44B2 7 0 1 0 3
M 8 0 0 6 1L 7 0 0 11 13
e174 | Clin. Oral Impl. Res. 25, 2014 / 171–178 © 2012 John Wiley & Sons A/S.
Cristache et al �Different retentions for implant mandibular overdenture
patient comparing with the other groups/sub-
group (60 EUR vs. 40 EUR) due to the higher
number of maintenance events.
The costs per patient/group/subgroup are
shown in Table 6. The magnet group recorded
statistically significant higher costs compar-
ing with the other two groups, whilst no
statistical significant differences were
observed between Group B and Group L, after
the 5-year evaluation (Kruskal–Wallis and
Mann–Whitney U-tests). The complication
costs for Subgroup B.1 vs. B.2 during years two
to five were 309.5 Euro/patient and 3.63 Euro/
patient, respectively.
Discussion
The use, in our clinical study, of two implants
as attachment for overdentures is based on the
clearly demonstrated success (Mericske-Stern
& Zarb 1993; Naert et al. 1999, 2004a) of using
fewer (generally two) implants and in accor-
dance with the proposed standard clinical
treatment protocol for edentulous elderly
patients in daily practice (Feine et al. 2002).
The implant survival rate of 97.1% after
5 years, including loss of implants during the
osseointegration period (early failure) is com-
parable with the studies of Buser et al. (1999)
(96.2%), Ferrigno et al. (2002) (95.9%) and
Lethaus et al. (2011) (96.7%), with the use of
the same implant system and the same sur-
face treatment.
The 6-week loading protocol performed in
this study is considered an early-loading pro-
tocol. The absence of implant failures after
loading is in agreement with other studies
(Payne et al. 2002; Roccuzzo & Wilson 2002).
In the light of our findings, the overall num-
ber of prosthetic and soft tissue complications
were relatively low compared with other stud-
ies (Mackie et al. 2011). Most of the mainte-
nance requirements were easy to handle:
screwing loosening abutments or activation of
the matrix to improve retention (Subgroup
B.1). Considerably more prosthetic mainte-
nance requirements were registered in sub-
group B.1, similar to the findings of Walton
et al. (2009), but different from Watson et al.
findings (Watson et al. 2002). The type of gold
matrix used in the present study consisted of
four lamellae functioning like a spring. All the
patients needed at least one activation of the
gold alloy matrix per year (i.e. 100% activation
per year). This result is different from Wal-
ton’s findings who reported, in a 3-year study,
only 73% need of matrix activation (Walton
2003). Four patients needed fully replacement
of the gold matrices due to impossibility of
Table 3. Baseline clinical characteristics of the study groups
GroupsB(n = 23)
M(n = 23)
L(N = 23)
Age (years)Mean (SD) 57.8 (8.8) 63.4 (9.5) 64 (9.6)Median 58 64 65Range [42–76] [47–84] [47–80]
Bone height in canine region (mm)Mean (SD) 25.3 (5.6) 26.2 (4.9) 24.2 (3.7)Median 24 25 24Range [16–44] [18–36] [18.5–30.8]
Bone quality*
N (%)Type I 4 (17.39) 1 (4.35) 4 (17.39)Type II 13 (56.52) 19 (82.61) 14 (60.87)Type III 6 (26.09) 3 (13.04) 5 (21.74)Type IV 0 0 0
Bone quantity*
N (%)Class A 1 (4.35) 0 0Class B 7 (30.43) 11 (47.83) 13 (56.52)Class C 8 (34.78) 9 (39.13) 5 (21.74)Class D 7 (30.43) 3 (13.04) 5 (21.74)
Interimplant distance (mm)Mean (SD) 20.1 (7.3) 20.3 (5.8) 20.1 (4.9)Median 21 22 19.1Range [7–38] [4–31] [11.6–34]
*Lekholm & Zarb (1985).
Table 4. Prosthodontic and soft tissue complications during 5 years of functioning
No. of events
Group B
Group M Group LB.1 B.2
Patrix-related (implant abutment) maintenanceFracture of the abutment screw 0 0 1 0Loosening of the abutment screw 1 2 3 0
Matrix-related (overdenture component) maintenanceActivation of matrix 144 0 0 0Exchange of rubber ring 18 0 0 0Exchange of stainless steel spring 0 0 0 0Exchange of the matrix 8 0 0 0Replacement male locator 0 0 0 22
Overdenture-related maintenanceRelining overdenture 4 2 3 1Fracture of the overdenture 0 0 1 0Fracture of teeth 2 1 1 0New overdenture 2 1 1 1
Soft tissue-related complicationsMucositis, soreness 3 1 2 2Ulcer decubitus 1 2 1 1Hyperplasia 1 2 2 4
Table 5. Six-field table analysis of prosthodontic success after 5 years of functioning according toPayne et al. (2001)
Group BN (%)
Group MN (%)
Group LN (%)
B.1N (%)
B.2N (%)
14 (56.5)Success 6 (50) 8 (72.7) 19 (82.6) 18 (78.3)Surviving 0 0 0 0Deceased 0 0 0 0Unknown 0 0 0 0
9 (39.1)Retreatment (repair) 6 (50) 3 (27.3) 4 (17.4) 5(21.7)Retreatment (replace) 0 0 0 0
© 2012 John Wiley & Sons A/S. e175 | Clin. Oral Impl. Res. 25, 2014 / 171–178
Cristache et al �Different retentions for implant mandibular overdenture
activation with breakage of one of the four
lamellae. The high number of maintenance
events usually recorded with this old version
matrix probably led to the replacement with
elliptical gold matrix.
No patrix wear for the retentive-anchor
patients (Group B) as well as no replacement
of stainless steel springs (titanium matrix)
occurred during the 5 years of functioning, in
contrast to previous findings (Watson et al.
2002; Walton 2003). The ball attachment
wear reported in other studies could be due
to misalignment of the implants (Walton
2003).
Prosthodontic success according to the six-
field table analysis (Payne et al. 2001)
(Table 6) was 50% for Group B.1 (retentive
anchors with gold matrix), that is, similar to
Mackie’s findings (Mackie et al. 2011) (54% in
5 years), but higher for Group B.2 (retentive
anchor with titaniummatrix, 72.7%). The pre-
viously mentioned study found a much lower
success rate for titanium matrix in 5 years
(33%).
An abutment fracture was recorded in
Group M. No similar events occurred during
the study. No such mechanical complica-
tions were described in other overdenture
studies with Straumann abutments (Rentsch-
Kollar et al. 2010; Mackie et al. 2011).
No wear or corrosion of magnetic abut-
ments was observed in 5 years of function.
Magnet abutments require lower skills for
wearing and cleaning and, especially due to
lower maintenance requirements, are recom-
mended to be used in elderly patients with
disabilities.
The highest number of events during the
first year was registered in Subgroup B.2 and
Group M, different from previous reported
results (Mackie et al. 2011). In the present
study, the most frequent complications during
the first year were soft tissue-related and acti-
vation of gold matrix (subgroup B.1). However,
the highest number of maintenance events
occurred during the fourth and fifth year of
service for Subgroup B.1 and Group L, mainly
consisting of matrix replacement.
The cost calculation was made taking into
consideration implant and component Strau-
mann prices (2009), for comparison reasons.
Gold matrix was last mentioned in that price
list (replaced with elliptical matrix).
From the cost calculation (Table 6), the
low initial cost for the implant treatment in
Subgroup B.1 has been noted, as opposed to
the high cost of the aftercare for the next
4 years. The lowest overall 5-year cost is
observed in Group B.2, followed in ascending
order by Group L, Subgroup B.1 and Group
M, respectively. Group M had an initially
high cost (components), but low aftercare
requirements. The highest costs represent a
hindrance in the use of magnets as attach-
ment for implant overdentures due to the
lower income of elderly patients and to the
fact that treatment is seldom supported by
the national or private health insurances.
The fact that significant differences were
partially recorded regarding costs and mainte-
nance requirements between the attachment
systems rejected the null hypothesis.
A limitation of the present study was the
heterogeneous maxillary status. Selection of
study participants who are all completely
edentulous in the maxilla would have allowed
for better standardization.
It can be concluded that, after 5-year follow-
up, the three attachment systems (retentive
anchor, magnets and locator) functioned well.
The implant-retained overdenture demands
continuous aftercare, especially when ball
attachment and golden matrix are used.
The magnets had a low maintenance
requirement and high success rate, despite the
relatively increased initial costs.
Retentive anchor with titanium matrix and
locator system may be better choices from a
financial point of view taking into consider-
ation the initial low cost of the components
and also the reduced number of complica-
tions.
The present findings do reflect that there
is variation in the maintenance of overden-
ture attachment systems. Because of this,
costs for maintenance of implant-retained
overdentures have considerable individual
variance and should not be universally inter-
preted.
Acknowledgments: The authors are
grateful to Associate Professor Dr. Roxana
Stegaroiu, Division of Oral Science for
Health Promotion, Department of Oral
Health and Welfare, Niigata University,
Japan, for useful comments and advice. This
study was supported by Grant No. 316/03
and Grant 507-207 from the ITI Foundation
for the Promotion of Oral Implantology,
Switzerland.
References
Albrektsson, T., Zarb, G., Worthington, P. & Eri-
ksson, A.R. (1986) The long-term efficacy of
currently used dental implants: a review and
proposed criteria of success. The International
Journal of Oral & Maxillofacial Implants 1:
11–25.
Alsabeeha, N.H., Payne, A.G., De Silva, R.K. &
Thomson, W.M. (2011). Mandibular single-
implant overdentures: preliminary results of a
Table 6. Computed costs in EUR (Euro) per patient and per group/subgroup
Subgroup B.1 Subgroup B.2 Group M Group L
Implants/components 694 770 1118 853Surgery 350 350 350 350Dental technician 200 200 200 200Prosthodontist 350 350 350 350Costs at delivery 1594 1670 2018 1753Costs at delivery per group 1630.34 2018 1753Aftercare and complications first year 60 40 40 40Total costs first year 1654 1710 2058 1793Aftercare 5 years 160 160 160 160Costs of complicationsper patient after 5 years
356.16 67.45 68.34 56.30
Total costs fifth yearMean (SD) 2170.16 (183.61) 1937.45 (115.89) 2286.34 (224.13) 2009.30 (89)Median 2106 1890 2218 1978Range 1974–2564 1870–2237 2218–3298 1953–2364
e176 | Clin. Oral Impl. Res. 25, 2014 / 171–178 © 2012 John Wiley & Sons A/S.
Cristache et al �Different retentions for implant mandibular overdenture
randomised-control trial on early loading with
different implant diameters and attachment sys-
tems. Clinical Oral Implants Research 22:
330–337.
Altman, D.G., Schulz, K.F., Moher, D., Egger, M.,
Davidoff, F., Elbourne, D., Gotzsche, P.C., Lang,
T. & Consort, G. (2001). The revised consort
statement for reporting randomized trials: expla-
nation and elaboration. Annals of Internal Medi-
cine 134: 663–694.
Aparicio, C., Rangert, B. & Sennerby, L. (2003).
Immediate/early loading of dental implants: a
report from the sociedad espanola de implantes
world congress consensus meeting in barcelona,
spain, 2002. Clinical Implant Dentistry &
Related Research 5: 57–60.
Buser, D., Mericske-Stern, R., Dula, K. & Lang,
N.P. (1999). Clinical experience with one-stage,
non-submerged dental implants. Advances in
Dental Research 13: 153–161.
Cakarer, S., Can, T., Yaltirik, M. & Keskin, C.
(2011). Complications associated with the ball,
bar and locator attachments for implant-sup-
ported overdentures. Medicina oral, patologia
oral y cirugia bucal 16: e953–e959.
Cune, M., Burgers, M., van Kampen, F., de Putter,
C. & van der Bilt, A. (2010). Mandibular overden-
tures retained by two implants: 10-year results
from a crossover clinical trial comparing ball-
socket and bar-clip attachments. International
Journal of Prosthodontics 23: 310–317.
Doig, G.S. & Simpson, F. (2005) Randomization
and allocation concealment: a practical guide for
researchers. Journal of Critical Care 20: 187–191.
Feine, J.S., Carlsson, G.E., Awad, M.A., Chehade,
A., Duncan, W.J., Gizani, S., Head, T., Lund, J.P.,
MacEntee, M., Mericske-Stern, R., Mojon, P.,
Morais, J., Naert, I., Payne, A.G., Penrod, J.,
Stoker, G.T. Jr, Tawse-Smith, A., Taylor, T.D.,
Thomason, J.M., Thomson, W.M. & Wismeijer,
D. (2002) The McGill consensus statement on
overdentures. Montreal, Quebec, Canada. May 24
–25, 2002. International Journal of Prosthodon-
tics 15: 413–414.
Ferrigno, N., Laureti, M., Fanali, S. & Grippaudo,
G. (2002). A long-term follow-up study of non-
submerged ITI implants in the treatment of
totally edentulous jaws. Part i: ten-year life table
analysis of a prospective multicenter study with
1286 implants. Clinical Oral Implants Research
13: 260–273.
Fitzpatrick, B. (2006). Standard of care for the eden-
tulous mandible: a systematic review. Journal of
Prosthetic Dentistry 95: 71–78.
Gotfredsen, K. & Holm, B. (2000). Implant-supported
mandibular overdentures retained with ball or bar
attachments: a randomized prospective 5-year
study. International Journal of Prosthodontics 13:
125–130.
Haruta, A., Matsushita, Y., Tsukiyama, Y., Sawae,
Y., Sakai, N. & Koyano, K. (2011) Effects of
mucosal thickness on the stress distribution and
denture stability of mandibular implant-sup-
ported overdentures with unsplinted attachments
in vitro. Journal of Dental Biomechanics 2011:
894395.
Heckmann, S.M., Winter, W., Meyer, M., Weber,
H.P. & Wichmann, M.G. (2001) Overdenture
attachment selection and the loading of implant
and denture-bearing area. Part 2: a methodical
study using five types of attachment. Clinical
Oral Implants Research 12: 640–647.
Jacobson, T.E. & Krol, A.J. (1983a). A contemporary
review of the factors involved in complete
denture retention, stability, and support. Part I:
retention. Journal of Prosthetic Dentistry 49:
5–15.
Jacobson, T.E. & Krol, A.J. (1983b). A contemporary
review of the factors involved in complete
dentures. Part II: stability. Journal of Prosthetic
Dentistry 49: 165–172.
Jacobson, T.E. & Krol, A.J. (1983c) A contemporary
review of the factors involved in complete
dentures. Part III: support. Journal of Prosthetic
Dentistry 49: 306–313.
Kimoto, S., Pan, S., Drolet, N. & Feine, J.S. (2009)
Rotational movements of mandibular two-implant
overdentures. Clinical Oral Implants Research 20:
838–843.
Lekholm, U. & Zarb, G. (1985) Patient selection and
preparation. In: Brinemark, P.-I., Zarb, G. &
Albreksson, T., eds. Osseointegration in Clinical
Dentistry, 199–209. Chicago: Quintessence
Publishing Co Inc.
Lethaus, B., Kalber, J., Petrin, G., Brandstatter, A. &
Weingart, D. (2011). Early loading of sandblasted
and acid-etched titanium implants in the edentu-
lous mandible: a prospective 5-year study. The
International Journal of Oral & Maxillofacial
Implants 26: 887–892.
Mackie, A., Lyons, K., Thomson, W.M. & Payne,
A.G. (2011). Mandibular two-implant overden-
tures: three-year prosthodontic maintenance
using the locator attachment system. Interna-
tional Journal of Prosthodontics 24: 328–331.
McGarry, T.J., Nimmo, A., Skiba, J.F., Ahlstrom,
R.H., Smith, C.R., Koumjian, J.H., Guichet, G.N.
& American College of Prosthodontics. (2004).
Classification system for the completely dentate
patient. Journal of Prosthodontics 13: 73–82.
Menicucci, G., Ceruti, P., Barabino, E., Screti, A.,
Bignardi, C. & Preti, G. (2006). A preliminary in
vivo trial of load transfer in mandibular implant-
retained overdentures anchored in 2 different
ways: allowing and counteracting free rotation.
International Journal of Prosthodontics 19:
574–576.
Mericske-Stern, R. (1998) Treatment outcomes with
implant-supported overdentures: clinical consid-
erations. Journal of Prosthetic Dentistry 79:
66–73.
Mericske-Stern, R. & Zarb, G.A. (1993) Overden-
tures: an alternative implant methodology for
edentulous patients. International Journal of
Prosthodontics 6: 203–208.
Moher, D., Schulz, K.F., Altman, D.G. & Group, C.
(2003) The consort statement: revised recommen-
dations for improving the quality of reports of
parallel-group randomised trials. Clinical Oral
Investigations 7: 2–7.
Morton, D. (2008) Consensus statements and
recommended clinical procedures regarding load-
ing protocols for endosseous dental implants. In:
Morton, D. & Ganeles, J., eds. ITI Treatment
Guide, 5–10. Berlin: Quintessence Publishing Co,
Ltd.
Naert, I., Alsaadi, G. & Quirynen, M. (2004a). Pros-
thetic aspects and patient satisfaction with
two-implant-retained mandibular overdentures: a
10-year randomized clinical study. International
Journal of Prosthodontics 17: 401–410.
Naert, I., Alsaadi, G., van Steenberghe, D. &
Quirynen, M. (2004b). A 10-year randomized
clinical trial on the influence of splinted and
unsplinted oral implants retaining mandibular
overdentures: peri-implant outcome. The Inter-
national Journal of Oral & Maxillofacial
Implants 19: 695–702.
Naert, I., Gizani, S., Vuylsteke, M. & van Steenberghe,
D. (1998). A 5-year randomized clinical trial on the
influence of splinted and unsplinted oral implants
in the mandibular overdenture therapy. Part i:
peri-implant outcome. Clinical Oral Implants
Research 9: 170–177.
Naert, I., Gizani, S., Vuylsteke, M. & Van Steenber-
ghe, D. (1999). A 5-year prospective randomized
clinical trial on the influence of splinted and
unsplinted oral implants retaining a mandibular
overdenture: prosthetic aspects and patient satis-
faction. Journal of Oral Rehabilitation 26:
195–202.
Payne, A.G., Tawse-Smith, A., Duncan, W.D. &
Kumara, R. (2002). Conventional and early loading
of unsplinted ITI implants supporting mandibular
overdentures. Clinical Oral Implants Research 13:
603–609.
Payne, A.G., Walton, T.R., Walton, J.N. & Solo-
mons, Y.F. (2001). The outcome of implant over-
dentures from a prosthodontic perspective:
proposal for a classification protocol. Interna-
tional Journal of Prosthodontics 14: 27–32.
Penrod, J. & Takanashi, Y. (2003) Measuring the
cost of implant overdenture therapy. In: Feine,
J. & Carlsson, G., eds. Implant Overdentures:
The Standard of Care for Edentulous Patients,
p. 48. Hanover Park: Quintessence Publishing
Co.
Rentsch-Kollar, A., Huber, S. & Mericske-Stern, R.
(2010). Mandibular implant overdentures followed
for over 10 years: patient compliance and pros-
thetic maintenance. International Journal of Pros-
thodontics 23: 91–98.
Roccuzzo, M. & Wilson, T. (2002). A prospective
study evaluating a protocol for 6 weeks’ loading
of sla implants in the posterior maxilla: one year
results. Clinical Oral Implants Research 13:
502–507.
Schulz, K.F., Altman, D.G., Moher, D. & Group,
C. (2010) Consort 2010 statement: updated
guidelines for reporting parallel group random-
ized trials. Annals of Internal Medicine
152: 726–732.
Vercruyssen, M., Marcelis, K., Coucke, W., Naert,
I. & Quirynen, M. (2010). Long-term, retrospec-
tive evaluation (implant and patient-centred
outcome) of the two-implants-supported over-
denture in the mandible. Part 1: survival
rate. Clinical Oral Implants Research 21: 357–
365.
Walmsley, D.A. (2005) Review of the clinical use of
magnets in implant retained overdentures. In:
Maeda, Y. & Walmsley, D.A., eds. Implant Den-
tistry with New Generation Magnetic Attach-
ment: Maximum Result with Minimum Number
© 2012 John Wiley & Sons A/S. e177 | Clin. Oral Impl. Res. 25, 2014 / 171–178
Cristache et al �Different retentions for implant mandibular overdenture
of Implants, 14–17. Tokyo: Qintessence Publish-
ing Co, Ltd.
Walton, J.N. (2003) A randomized clinical trial
comparing two mandibular implant overdenture
designs: 3-year prosthetic outcomes using a six-
field protocol. International Journal of Prostho-
dontics 16: 255–260.
Walton, J.N., Glick, N. & MacEntee, M.I. (2009). A
randomized clinical trial comparing patient satis-
faction and prosthetic outcomes with mandibular
overdentures retained by one or two implants.
International Journal of Prosthodontics 22:
331–339.
Watson, G.K., Payne, A.G., Purton, D.G. & Thom-
son, W.M. (2002) Mandibular overdentures: com-
parative evaluation of prosthodontic maintenance
of three different implant systems during the first
year of service. International Journal of Prostho-
dontics 15: 259–266.
Weingart, D. & ten Bruggenkate, C.M. (2000) Treat-
ment of fully edentulous patients with ITI
implants. Clinical Oral Implants Research 11
(Suppl 1): 69–82.
Zitzmann, N.U., Marinello, C.P. & Sendi, P.
(2006). A cost-effectiveness analysis of implant
overdentures. Journal of Dental Research 85:
717–721.
Supporting Information
Additional Supporting Information may be
found in the online version of this article:
Data S1. CONSORT 2010 checklist of infor-
mation to include when reporting a rando-
mised trial*
e178 | Clin. Oral Impl. Res. 25, 2014 / 171–178 © 2012 John Wiley & Sons A/S.
Cristache et al �Different retentions for implant mandibular overdenture