Manal A.

Awad The effect of mandibular 2-implant

Faahim Rashid
Jocelyne S. Feine
overdentures on oral health–related
on behalf of the Overdenture quality of life: an international
Effectiveness Study Team
Consortium
multicentre study

Authors’ affiliations: Key words: clinical research, clinical trials, epidemiology, prosthodontics
Manal A. Awad, Department of General &
Specialist Dental Practice, College of Dentistry,
University of Sharjah, Sharjah, UAE Abstract
Faahim Rashid, Faculty of Dentistry, Ajman Objectives: To determine the difference in oral health–related quality of life (OHRQoL) in patients
University of Science & Technology, Ajman, UAE
who received mandibular 2-implant overdentures and conventional dentures in a pragmatic
Jocelyne S. Feine, Faculty of Dentistry, McGill
University, Montreal, QC, Canada international study.
Materials and methods: In this prospective study, data were gathered from 203 edentulous
Corresponding author:
Prof. Jocelyne S. Feine
patients (mean age, 68.8; SD: 10.4 years) at eight centres in North America, South America and
Oral Health Society Research Unit Europe. The patients were provided with new mandibular conventional dentures or implant
Room 102, 3550 University Street overdentures supported by 2 implants and ball attachments and opposed by conventional
Zip Code H3A2A7
Montreal, QC dentures. At baseline and at 6 months post-treatment, patients rated their oral health–related
Canada quality of life using the OHIP-20.
Tel.: 514 398-7203 Results: A significantly higher proportion of the participants in the implant group in North
Fax: 514 398 8900
e-mail: Jocelyne.feine@mcgill.ca America reported improvement in both the psychological and the handicap domains, compared to
those who received conventional dentures (93% vs. 52%; P < 0.05). In South America, 100% of
participants who received implant overdentures reported improvement in physical pain, compared
to 66% in the conventional group (P < 0.05). Differences in mean change scores among those who
expressed improvement were not significantly different between sites or treatments.
Conclusion: Mandibular 2-implant overdentures are more likely than conventional dentures to
improve OHRQL for edentulous patients. Cultural differences were also observed in the impact of
implant overdentures on the different domains of the OHIP-20.

Overdenture Effectiveness Study Team Consortium
members: Allen F, Heydecke G, Mojon P, M€
Piovano A, Scilingo E, Spielberg GP, Spielberg M,
Stoker G, Thomason JM, Wismeijer D.
Date:
Accepted 1 May 2013
To cite this article:
Awad MA, Rashid F, Feine JS. The effect of mandibular
2-implant overdentures on oral health–related quality of life:
an international multicentre study.
Clin. Oral Impl. Res. 25, 2014, 46–51
doi: 10.1111/clr.12205
During the past two decades, there has been
an increased international focus on measur-
ing the patient’s perspective when evaluating
the burden of edentulism and the benefits of
various treatment options (De Grandmont
et al. 1994; Geertman et al. 1996; Awad et al.
2000a, 2003; Allen et al. 2006; Harris et al.
2011). Several randomized controlled trials
were carried out in many parts of the world
to assess the impact of mandibular 2-implant
overdentures and conventional dentures
(Geertman et al. 1996; Awad et al. 2000a;
Allen et al. 2006; Ellis et al. 2008). In gen-
eral, reports from these studies indicated that
uller F,
patients who received mandibular 2-implant
overdentures were significantly more satis-
fied and reported significant improvements in
their oral health–related quality of life than
those who received conventional dentures.
These randomized controlled trials were
carried out under ideal circumstances, in
which selection of patients is based on strict
eligibility criteria, and homogenous groups of
participants who meet the inclusion criteria
are randomly assigned to treatment arms.
These conditions are necessary in random-
ized controlled trials to answer the question
of efficacy. However, in some trials, patients
do not pay the full cost of the assigned treat-
ment (Awad et al. 2003; Rashid et al. 2010)
because financial issues may have an impact
on the outcome of therapy (Rashid et al.
2010). Accordingly, patients enrolled in clini-
cal trials and the circumstances under which
they receive the tested treatments may not
reflect the complexity and diversity of actual
clinical practice (Rashid et al. 2010; Sackett
2011; Ware & Hamel 2011). Therefore, the
question that remains unanswered is: Under
normal clinical environments in which heter-
ogeneous groups of patients receive the
treatment, what would be the impact of
2-implant overdentures on a patient’s satis-
faction and quality of life? To answer this

46 © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
 Awad et al ! 2-implant overdentures, quality of life

question, a pragmatic trial should be consid- Table 1. Recruitment site according to treatment received
ered, in which the clinical management of Implant Conventional
patients is consistent with usual care (Rashid Site group (%) group (%) Total (%)
et al. 2010). Canada 0 (0) 23 (23) 23 (11)
The aim of this multisite prospective study USA 15 (14) 0 (0) 15 (7)
Switzerland 12 (12) 6 (6) 18 (9)
was to compare the effectiveness of mandibu-
Netherland 16 (15) 8 (8) 24 (12)
lar 2-implant overdentures and conventional Ireland 5 (5) 20 (21) 25 (12)
dentures under “real world” conditions in Germany 20 (19) 17 (17) 37 (18)
which patients choose their therapy with United Kingdom 19 (19) 13 (13) 32 (16)
Argentina 17 (16) 12 (12) 29 (15)
their dentists and when the some or all of Total 104 (100) 99 (100) 203 (100)
the cost of the treatment is paid in the
customary manner.
Previously, we showed that, at 6 months
post-treatment, patients who received man-
exclusion criteria were applied. Clinicians to the OHIP-20 at baseline and at 6 months
dibular 2-implant overdentures were signifi-
delivering the treatments used standard prac- post-treatment. This questionnaire was previ-
cantly more satisfied with their ability to
tice methods; clinicians were also given the ously translated to different languages and
chew, stability, ability to speak and overall
leeway to treat each patient as they would do used in several studies (Awad et al. 2000a;
satisfaction with their prostheses than those
in their every day practice. All participants John et al. 2004; Allen et al. 2006; Ellis et al.
who received conventional dentures (Rashid
were treated within the clinical centres of 2008; Lindeboom & van Wijk 2010; Harris
et al. 2010). In this study, we assessed the
academic dental schools. et al. 2011; S"anchez et al. 2011; Schimmel
impact of mandibular 2-implant overdentures
Sociodemographic data regarding age, gen- et al. 2011).
on oral health–related quality of life
der, marital status, level of education and
compared to conventional dentures among
income were collected from all participants. Data analysis
patients from different sites internationally.
In addition, patients were asked to respond to Descriptive statistics for sociodemographic
the 20-item OHIP questionnaire (Allen & variables were displayed according to treat-
Locker 2002) that consists of seven domains: ment received.
Methods Using baseline and post-treatment scores,
functional limitations, physical pain, psycho-
logical discomfort, physical disability, psy- participants were divided into three catego-
The estimated sample size needed to detect a
chological disability, social disability and ries, those who improved (positive score),
difference with the primary outcome of the
handicap. Responses to each OHIP question, those who stayed the same and those who
study, general satisfaction ratings on a
within the previously described seven sub- got worse (John et al. 2009). Mann–Whitney
100 mm VAS, was 174 participants (power
scales, were presented on a 6-point Likert tests were used in this study to compare
80%, alpha 0.05, two tailed). An additional
scale ranging from: 0 = never, 1 = rarely, between treatments overall scores, as well
20% were recruited to compensate for loss to
2 = occasionally, 3 = often, 4 = very often, as scores according to patterns of change.
follow-up, reaching a total of 209 partici-
5 = all of the time. Higher scores would indi- We opted to report pattern of change, rather
pants. This sample size is also sufficient to
cate more problems. A total OHIP score was than simply providing a mean change in
detect the minimally important difference in
obtained by summing up the scores for all of score that might fail to identify direction
the total OHIP-20 score of approximately 10
the domains. Patients were asked to respond and magnitude of change. As change in oral
points (SD: 17) (Awad et al. 2003), using
alpha 0.05 (two tailed) and 80% power.
Participants in this study were edentulous
patients who wish to replace their current Table 2. Sociodemographic patient data, according to treatment received
prostheses with either conventional dentures Implant Conventional
or mandibular overdentures retained by two Variable 104 N = 99 P-value*
implants. Patients were recruited from eight Sex
sites around the world including: two sites in Male 39 (39) 43 (42) 0.55
Female 62 (61) 58 (57)
North America (Montreal, QC, Canada; Ann
Education status
Arbor, Michigan, United States), one site in At least elementary 35 (37) 45 (48) 0.51
South America (Buenos Aires, Argentina) and At least college 54 (54) 48 (51)
five sites in Europe (Geneva and Bern, Swit- Not applicable 8 (9) 1 (1)
Employment
zerland; Breda, Netherlands; Cork, Ireland; Employed 22 (22) 24 (26) 0.17
Freiburg, Germany; Newcastle, United King- Unemployed 76 (77) 69 (73)
dom) (Table 1). The Montreal site formed the Not applicable 1 (1) 1 (1)
Income 0.42
central coordinating centre in this trial. Simi-
Earn <39,999 $ 58 (57) 35 (48)
lar to usual clinical practice, full range of Earn more than 39,999 $ 9 (9) 11 (15)
practitioners who are experienced in provid- Prefer not to say 25 (9) 26 (37)
ing these treatments discussed the treat- Living status
Live alone 22 (23) 23 (24) 0.62
ments with their patients and decisions were Live with family or others 76 (77) 72 (76)
made accordingly. To keep the study as real-
*
Based on Chi-square test.
istic as possible, no additional inclusion or

© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd 47 | Clin. Oral Impl. Res. 25, 2014 / 46–51
Awad et al ! 2-implant overdentures, quality of life

health–related quality of life as a result of
treatment may occur in both directions,
using aggregated change scores may mask
the possibility that while some patients in
the implant group or conventional group
may report lower OHIP scores (indicating
improvement), others may report higher
scores (suggesting deterioration) and some
may not report any change (John et al. 2009;
Tsakos et al. 2012).
For the purpose of comparing OHIP scores
by site, sites were divided into: North Amer-
ica (Canada and USA), Europe (Switzerland,
Netherlands, Ireland, Germany, United King-
dom) and South America (Argentina).
Among those who improved, Kruskal–Wallis
tests were utilized to compare change in
scores by site according to treatment
received. In addition, a Chi-square test was
also used to compare the percentage of
patients who improved, stayed the same or
got worse, according to treatment received.
Multivariate regression analysis was utilized
to assess the association between OHIP-20
change in scores, treatment and site adjusted
for age, sex and level of education. Based on
Wilcoxon signed-rank test effect, sizes were
also calculated using the absolute value of
the Z score and the number of matched
pairs included in the analysis.
To address potential bias created from
missing data, multiple imputation was
applied to primary and secondary outcome
variables. Multiple imputation is a statistical
technique designed to reduce the bias that
can occur from missing data by allowing
participants with incomplete data to be
included in analyses (Sterne et al. 2009). In
this approach, a model is posited for the

Table 3. Comparison between 2-implant overdentures and conventional dentures in OHIP-20 domain scores by site
North America (N = 38) Europe (N = 136) South America (N = 29)

Treatment Implant N = 15 Conventional N = 23 Implant N = 72 Conventional N = 64 Implant N = 17 Conventional N = 12

Total OHIP-20
Median (IQR) 42.8 (28.0, 66.1)*,† 21.1 (9.0, 35.0) 23.7 (4.0, 40.0) 13.0 (2.0, 26.0) 43 (16.4, 65.7) 22.2 (6.8, 52.5)
Improved N (%) 14 (93) 19 (83) 63 (88)‡ 50 (78) 17 (100) 11 (92)
Median (IQR) 44.9 (27.5, 64.4)* 24.0 (14.5, 43) 26.7 (10.5, 45.0) 22.7 (8.4, 38.0) 43 (16.4, 65.7) 26.0 (12.0, 57.4)
Same N (%) 0 0 3 (5) 0 0 0
Worse N (%) 1 (7) 4 (17) 6 (7) 14 (22) 0 1 (8)
Functional limitations
Median (IQR) 7.2 (4.8, 10.9) 6.0 (1.1, 6.0) 5.9 (1.0, 9.0) 5.3 (1.0, 8.0) 7.0 (3.0, 9.0) 6.1 (2.3, 8.8)
Improved N (%) 15 (100) 18 (78) 53 (74) 50 (78) 16 (94) 11 (92)
Median (IQR) 7.3 (4.9, 11.2) 8.5 (4.3, 11.2) 8.0 (4.9, 10.3) 6.3 (4.3, 9.6) 7.5 (3.0, 9.3) 5.2 (3.2, 8.9)
Same N (%) 0 1 (5) 10 (14) 3 (5) 1 (6) 1 (8)
Worse N (%) 0 4 (17) 9 (13) 11 (17) 0 0
Physical Pain
Median (IQR) 9.6 (5.0, 13.2) 5.0 (2.2, 11.0) 5.5 (1.0.9.0) 8.5 (1.0, 8) 10.7 (5.5, 10.7) 6.3 (1.0, 10.2)
Improved N (%) 14 (93) 20 (87) 55 (76) 44 (69) 17 (100)*† 8 (66)
Median (IQR) 10.2 (5.1, 13.1) 5.0 (4, 12.8) 7.0 (4.0, 10.0) 6.3 (1.0, 12.0) 10.7 (5.5, 10.7) 7.0 (5.7, 11.5)
Same N (%) 0 0 9 (13) 3 (5) 0 2 (16)
Worse N (%) 1 (7) 3 (13) 8 (11) 17 (26) 0 2 (16)
Psychological disability
Median (IQR) 6.9 (5.5, 9.1)*,† 2.0 (1.0, 5.0) 3.0 (1.0, 9.0) 2.0 (0.7.0) 5.5 (2.5, 8.0) 4.5 (1.2, 7.5)
Improved N (%) 14 (93) 12 (52) 52 (72) 42 (66) 16 (94) 8 (66)
Median (IQR) 6.8 (5.1, 9.0)* 4.3 (2.8, 6.3) 4.4 (2.7, 4.9) 3.5 (2.0, 8.0) 5.8 (3.1, 5.9) 5.5 (2.0, 8.0)
Same N (%) 0 5 (22) 13 (18) 6 (9) 1 (6) 2 (16)
Worse N (%) 1 6 (26) 7 (10) 16 (25) 0 2 (16)
Physical disability
Median (IQR) 8.0 (3.1, 8.3) 5.0 (1.0, 9.1) 2.3 (0, 10.0) 1.0 ("1, 6) 9.6 (2.5, 15.0) 1.0 ("3.0, 11.5)
Improved N (%) 13 (93) 19 (83) 50 (69)‡ 31 (48) 15 (88) 7 (58)
Median (IQR) 8.7 (4.0, 14.0) 6.0 (3.0, 9.0) 7.0 (6.9, 13.0) 2 (0, 7) 12.0 (4.0, 16.0) 7.0 (1.0, 17.0)
Same N (%) 0 1 (4) 13 (18) 2 (3) 2 (12) 1 (8)
Worse N (%) 2 (7) 3 (13) 9 (12) 31 (48) 0 4 (33)
Psychological discomfort
Median (IQR) 5.5 (5.1, 7.0)*,† 1.8 (1.0, 3.0) 2.0 (0, 5.0) 1.0 ("1, 4) 6.0 (2.0, 8.0) 1.8 (0, 9.0)
Improved N (%) 13 (93) 12 (52) 47 (65)‡ 32 (50) 16 (94)‡ 8 (67)
Median (IQR) 5.7 (5.2, 7.4) 7.5 (5.2, 10.1) 7.0 (2.3, 13.0) 5.0 (1, 8) 6.0 (2.2, 8.0) 6.0 (1.7, 9.8)
Same N (%) 0 5(22) 13 (18) 6 (8) 1 (6) 2 (16)
Worse N (%) 2 (7) 6 (26) 12 (17) 26 (41) 0 4 (33)
Social discomfort
Median (IQR) 2.03 (1.0, 7.0) 1.0 (0, 1.3) 0 ("1.0, 3.0) 0 ("1, 1) 1.0 (0, 4.5) 1.0 (0, 3.6)
Improved N (%) 12 (80)‡ 5 (22) 29 (40)‡ 17 (27) 9 (53) 6 (50)
Median (IQR) 4.4 (1.6, 7.9)* 2.5 (1.0, 5.4) 3.0 (1.0, 7.0) 0.9 (0, 1) 4.0 (2, 9.4) 2.5 (1.0, 5.0)
Same N (%) 1 (6) 10 (43) 20 (28) 11 (17) 7 (41) 4 (33)
Worse N (%) 2 (13) 8 (35) 23 (32) 36 (56) 1 (6) 2 (17)
Handicap
Median (IQR) 5.0 (3.0, 7.1) 1.0 (0.8, 2.0) 1.0 (0, 5) 0 ("1, 2) 1 (0, 6.5) 1.0 (0, 2.9)
Improved N (%) 14 (93) 12 (52) 37 (60)‡ 22 (34) 9 (53) 5 (42)
Median (IQR) 5.0 (3.1, 7.0)* 2.1 (2.0, 5.6) 4.2 (1.0, 6.5) 1.8 (1.0, 5.0) 6.0 (3.0, 7.7) 1.5 (1, 4.5)
Same N (%) 0 5 (22) 17 (24) 11 (17) 6 (35) 2 (25)
Worse N (%) 1 (7) 6 (26) 18 (25) 31 (48) 2 (12) 4 (33)
*
P < 0.05, based on Kruskal Wallis test.
†
P < 0.05, based on Mann–Whitney test, P < 0.05.
‡
Based on Chi-square test, P < 0.05.

48 | Clin. Oral Impl. Res. 25, 2014 / 46–51 © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
 Awad et al ! 2-implant overdentures, quality of life

association between missing values and Table 4. Multiple regression analysis for the association between OHIP-20 change in scores,
treatment received and site
recorded values. This model is used to gener-
ate several replicate “completed” data sets, Variable B 95% CI P-value

containing imputed values in place of the Total OHIP-20

missing values. Estimates of the parameters Female* 7.0 0.15, 13.8 0.04
Age 1.0 "6.1, 8.1 0.78
of interest in each completed data set, with At least college† 6.1 "0.76, 12.9 0.08
their variance, are then pooled using multiple Implant‡ 10.4 3.5, 17.3 0.003
imputation rules. Five separate imputation North America§ 10.2 1.3, 18.9 0.02
South America§ 12.8 2.7, 22.9 0.01
samples were generated using SPSS version
Functional limitations
18 (PASW, 2010). Female 0.78 "0.65, 2.14 0.29
Age 0.35 "1.1, 1.78 0.63
At least college 1.67 0.32, 3.0 0.02
Results Implant 1.0 "0.31, 2.4 0.10
North America 1.5 "0.4, 3.4 0.10
South America 1.8 "0.3, 3.8 0.09
Of the 203 participants in this study, 102
Physical pain
(50.2%) had valid baseline and 6-month Female 1.57 "0.73, 3.89 0.18
OHIP-20 data. Among those with incomplete Age "0.41 "2.46, 1.65 0.41
At least college 2.06 "0.56, 4.68 0.11
6-month data, an equivalent number of
Implant 0.66 "1.71, 3.0 0.58
patients chose implant overdentures (n = 49) North America 1.80 "122, 4.71 0.24
and complete dentures (n = 52). No signifi- South America 3.20 "0.24, 6.52 0.06
cant differences were observed between those Psychological disability
Female 1.0 "0.53, 2.55 0.19
with incomplete data and complete data in
Age 0.75 "0.68, 2.16 0.30
any sociodemographic variables (Rashid et al. At least college 0.55 "0.61, 1.71 0.35
2010). In addition, no significant differences Implant 1.56 0.21, 2.92 0.03
were observed between patients in the North America 0.54 "1.2, 2.25 0.53
South America 1.0 "0.85, 2.86 0.28
implant group and those in the conventional Physical disability
group (Table 2). Female 1.3 "0.71, 3.26 0.21
The percentage of patients who improved, Age 0.08 "2.1.1.86 0.93
At least college 0.96 "0.97, 2.9 0.32
stayed the same or got worse according to
Implant 3.31 1.4.5.03 0.001
geographical site and treatment received are North America 3.42 0.95, 5.9 0.007
shown in Table 3. Accordingly, the highest South America 2.86 0.15, 5.58 0.04
percentage of participants who reported Psychological discomfort
Female 1.4 0.43, 2.4 0.005
improvements in the different OHIP-20 Age 0.22 "0.93, 1.37 0.39
domains (functional limitations, physical dis- At least college 0.31 "0.83, 1.47 0.58
ability, social discomfort and handicap) due Implant 1.52 0.44, 2.60 0.006
to implant treatment were in North Amer- North America 1.08 "0.67, 2.83 0.21
South America 2.04 0.13, 3.95 0.04
ica. The median change scores of the total Social disability
OHIP-20 among participants who received Female 0.45 "0.61, 1.52 0.40
implant overdentures were significantly Age 0.07 "0.98, 1.13 0.65
At least college 0.23 "0.77, 1.22 0.13
lower among Europeans than among North
Implant 1.1 0.06, 2.1 0.04
and South Americans (Europeans: median North America 0.73 "0.68, 2.13 0.31
26.7, IQR: 10.5, 45.0; North Americans: med- South America 1.34 "0.2, 2.9 0.09
ian: 44.9, IQR: 27.5, 64.4; South America: Handicap
Female 0.54 "0.46, 1.55 0.29
median 43.0, IQR: 16.4, 65.7; P < 0.05). Simi- Age 0.11 "1.02, 1.25 0.84
lar findings are also observed after adjust- At least college 0.32 "0.85, 1.5 0.57
ment for age, sex and level of education in Implant 1.14 0.26, 2.5 0.02
North America 1.12 "0.13, 2.39 0.07
the multiple regression model (Table 4). The
South America 0.66 "0.67, 8.0 0.33
effect sizes associated with implant treat-
*
ment were highest among participants from Male.
†
At least elementary education.
South America and lowest among European ‡
Conventional treatment.
participants who received conventional §
Europe.
dentures (Table 5).

Discussion
We conducted the present study to assess
the impact of implant overdentures on qual-
ity of life of patients from eight countries,
in which broader eligibility criteria from a
variety of practice settings would ensure
the inclusion of the type of patients whose
care will actually be influenced by the
study results. The standardization in the
collection of data using the OHIP-20 (Allen
& Locker 2002) allows us to examine the
OHRQL associated with each treatment
modality and to compare results across
sites. Furthermore, the original OHIP-20
and its short forms were previously used to
assess oral health–related quality of life of
edentulous patients in all eight countries
included in this study (Awad et al. 2000a;
John et al. 2004; Allen et al. 2006; Ellis
et al. 2008; Lindeboom & van Wijk 2010;

© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd 49 | Clin. Oral Impl. Res. 25, 2014 / 46–51
Awad et al ! 2-implant overdentures, quality of life
Table 5. Effect size* according to treatment received and site
North America
Domain Implant Conventional
Functional Limitations 0.71 0.67
Physical pain 0.62 0.66
Psychological disability 0.61 0.45
Physical disability 0.60 0.70
Psychological discomfort 0.55 0.51
Social discomfort 0.54 0.10
Handicap 0.61 0.45
Total OHIP 0.70 0.70
*
Based on Wilcoxon signed-rank test.
Harris et al. 2011; S" anchez et al. 2011;
Schimmel et al. 2011).
Our findings show that a significantly
higher proportion of patients who received
implant overdentures reported improvement
in their oral health–related quality of life
than those who received conventional den-
tures. However, differences were observed
between North America, Europe and South
America in the interpretation of the impact
of implant overdentures on OHRQL. The
majority of patients in North America who
received implant overdentures reported
improvements in all domains of the OHIP-
20 compared to other sites. One explanation
for these findings is that different cultural
groups may value aspects of their quality of
life differently (Parker & Fox-Rushby 1995;
Kagawa-Singer et al. 2010). For example, in
one culture, implant overdentures reduce
the negative impact of oral health on social
activities, which is reflected in the post-
treatment change in the social domain score
of the OHIP-20. Whereas in another culture,
there may be relatively small change
occurring in social life as a result of a new
prosthesis. Cultural differences and their
relationship to quality of life have been also
addressed for other medical conditions (Par-
ker & Fox-Rushby 1995; Scott et al. 2008;
Molzahn et al. 2011). Based on 125 data sets
from cancer patients from different parts of
the world, Scott et al. reported that the
emotional functioning scale of the EORTC
has less influence on ratings of overall qual-
ity of life in Latin America than in some
European countries; at the same time, physi-
cal functioning appears to have similar
effects on overall quality of life from Europe,
North America and Latin America (Scott
et al. 2008). These findings, as well as ours,
underscore the importance of addressing cul-
tural differences when conducting clinical
trials that include participants from different
countries.
An interesting, and somewhat surprising,
finding in this study is the large effect size
50 | Clin. Oral Impl. Res. 25, 2014 / 46–51
Europe South America
Implant Conventional Implant Conventional
0.73 0.73 0.85 0.84
0.75 0.68 0.88 0.25
0.64 0.40 0.87 0.25
0.70 0.33 0.83 0.30
0.30 0.36 0.85 0.60
0.58 0.02 0.63 0.57
0.58 0.22 0.64 0.60
0.75 0.67 0.88 0.81
observed for the handicap domain among par-
ticipants in the implant group, especially in
North America. These findings are in con-
trast to those reported in other randomized
controlled trials (Awad et al. 2000b; Allen
et al. 2006; Harris et al. 2011), in which this
domain has the least change resulting from
new implant-retained prostheses. One expla-
nation provided by Harris et al. (2011) is that
these questions tend to ask about issues
related to depression and avoidance of social
interaction that prosthodontic therapy may
not address adequately. Arguably, our find-
ings could be attributed to participants’
involvement in the treatment decision pro-
cess. Accordingly, those who wanted implant
overdentures may have chosen this treatment
not only to improve function and reduce
physical pain, but because they anticipated
an impact from this treatment on other
aspects of their lives that may have been dis-
advantaged due to an unsatisfactory prosthe-
sis. Nonetheless, it should be noted that the
mean change in score among those who
reported improvement was relatively lower
in the social and handicap domain than in
other OHIP-20 domains. This could also indi-
cate that, in general, edentulous people do
not perceive themselves as disadvantaged
socially or in the work place from their
condition.
In general, a higher percentage of patients
in the conventional denture group reported
that their overall oral health–related quality
of life became worse, as well as in various
domains of the OHIP-20; this finding could
indicate that patients’ expectations were not
met by their new conventional dentures
(Hydecke et al. 2008). Another possible
explanation is that external factors, such as
cost of treatment, may have played a role in
the selection of prostheses (Rashid et al.
2010).
Several inferences about the conduct of
future multicentre studies of implant over-
dentures and conventional dentures can be
drawn from the present study. Multicentre
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
studies are used to gather data when one
site cannot provide the necessary sample
size. They can also be used to determine dif-
ferences in outcome between geographical
areas or cultures. This type of study requires
a high level of communication, specific
training in data collection and any other
method that must be calibrated, dedicated
involvement from individuals at each site, a
well-planned data sharing protocol and a
strong collaborative commitment from all
involved.
It should be noted that some clinicians
might have excluded patients with severe
mandibular residual ridge resorption from
opting for implant treatment. They then may
have been included in the conventional den-
ture group, which could have increased the
difference between the two groups in favour
of the implant treatment.
Furthermore, the observed differences in
this study are applicable only to the provi-
sion of mandibular 2-implant overdentures
and conventional dentures. Some edentulous
patients may require different types of pros-
theses to be adequately treated. Thus, these
findings should not be extrapolated to
patients who receive more than two mandib-
ular implants or fixed implant prosthesis.
Finally, as with all follow-up studies, this
study includes missing data that were
replaced using a statistical approach.
Although multiple imputation is the recom-
mended method for replacement of missing
values (Royston 2004), estimates from origi-
nal complete data are clearly desirable. In
addition, our sample sizes for some sites
were relatively small and, therefore, aggrega-
tion of data to three sites was necessary for
this analysis. Future studies that include lar-
ger sample sizes are needed to further explore
cultural effects on OHRQL.
In conclusion, our findings suggest that
there are international and cultural differ-
ences in the contribution of implant overden-
tures to different aspects of OHRQL, and this
may impact on the results of studies con-
ducted in more than one country. However,
the overall findings are in agreement with
results from randomized clinical trials on the
positive impact of implant overdentures on
OHRQL of edentulous patients.
Acknowledgements: The authors are
grateful to Nicolas Drolet and Stephanie
Wollin for study coordination and data
collection. This study was funded by a grant
from the International Team for
Implantology (ITI).

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