J Clin Periodontol 2012; 39(Suppl. 12): 7380 doi: 10.1111/j.1600-051X.2011.01843.

Clinical research in implant

dentistry: study design, reporting
and outcome measurements:
consensus report of Working
Group 2 of the VIII European
Workshop on Periodontology

Maurizio Tonetti1, Richard Palmer2

and on behalf of Working Group 2 of
the VIII European Workshop on
Periodontology*
1

European Research Group on

Periodontology (ERGOPerio), Genova, Italy;
2
Kings College London Dental Institute,
Guys Hospital Campus, London, UK

Tonetti M, Palmer R, on behalf of Working Group 2 of the VIII European

Workshop on Periodontology. Clinical research in implant dentistry: study design,
reporting and outcome measurements; consensus report of Working Group 2 of the
VIII European Workshop on Periodontology. J Clin Periodontol 2012; 39(Suppl.
12): 7380. doi: 10.1111/j.1600-051X.2011.01843.x.
Abstract
Aims: The objective of this working group was to assess and make specic recommendations to improve the quality of reporting of clinical research in implant
dentistry and discuss ways to reach a consensus on choice of outcomes.

Key words: human research; implant

dentistry; observational research; outcomes;
quality of reporting; randomized clinical trials;
risk factors
Accepted for publication 08 November 2011

Conflict of interest and source of funding statement

The authors declare that they have no conict of interests. This workshop was
nancially supported by the European Federation of Periodontology and by unrestricted grants from Astra, Nobel Biocare and Straumann
*
Working Group 2:
Maurizio Tonetti,
Richard Palmer,
Zvi Artzi,
Francesco Cairo,
Mauro Donati,
William Giannobile,
Eli Machtei,
Phoebus Madianos,
Henny Meijer,
Ian Needleman,
Friedrich W. Neukam,
David Nisand,
Marc Quirynen,
Isabella Rocchietta,
Ignacio Sanz,
Leonardo Trombelli,
Yu-Kang Tu,

Industry representation:
Frederick Ceder,
Michael Hotze,
Alexandra S. Rieben.

2012 John Wiley & Sons A/S

73

74

Tonetti et al.

Material and Methods: Discussions were informed by three systematic reviews on

quality of reporting of observational studies (case series, case-control and cohort)
and experimental research (randomized clinical trials). An additional systematic
review provided information on choice of outcomes and analytical methods. In
addition, an open survey among all workshop participants was utilized to capture
a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome
systems.
Results: The Workshop attempted to clarify the characteristics and the value in
dental implant research of dierent study designs. In most areas, measurable
quality improvements over time were identied. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of
outcomes, the limitations of currently used systems were recognized. Three broad
outcome domains that need to be captured by future research were identied: (i)
patient reported outcome measures, (ii) peri-implant tissue health and (iii)
performance of implant supported restorations. Peri-implant tissue health can be
measured by marginal bone level changes and soft tissue inammation and
can be incorporated in time to event analyses.
Conclusions: The Workshop recommended that collaboration between clinicians
and epidemiologists/clinical trials specialists should be encouraged. Aspects of
design aimed at limitation of potential bias should receive attention by clinical
researchers, funding agencies and journal editors. Adherence to appropriate
reporting guidelines such as STROBE and CONSORT are necessary standards.
Research on outcome measure domains is an area of top priority and should
urgently inform a proper process leading to a consensus on outcome measures in
dental implant research.

The remit of this working group was

to critically discuss quality of reporting, study design and choice of outcomes in clinical research in implant
dentistry and identify areas of priorities for improvement in design and
reporting of future research. It is recognized that data discussed in the
workshop are based on quality of
reporting (and not on quality of
research) and risk of bias of published research. Such data, however,
may be used to assist in improving
both design and reporting of future
studies.
Three systematic reviews evaluated in a systematic manner the
quality of reporting of case series
(Meijer & Raghoebar 2012), casecontrol and cohort studies (Rocchietta & Nisand 2012) and randomized
clinical trials (Cairo et al. 2012)
in implant dentistry. A fourth review
systematically assessed the choice
of outcomes, the analytical methods
and reference groups in clinical
implant
dentistry
research
(Needleman et al. 2012).
Fig. 1. Algorithm for classication of various types of clinical research (from Grimes
& Schulz 2002).
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Clinical research in implant dentistry

Role of Experimental and
Observational Research Designs in
Current Implant Dentistry

Considerable confusion exists in

implant dentistry with regard to
study design and the research questions that can be best answered by
each design.
Identication of the reported
research design in publications is
sometimes a challenge. Grimes &
Schulz (2002) have recognized this in
medicine and have provided a useful
classication of the most frequently
used study designs (Fig. 1). They
reported that Clinical research falls
into two general categories: experimental and observational, based on
whether the investigator assigns the
exposures or not. Experimental trials
can also be subdivided into two:
randomised
and
non-randomised.
Observational studies can be either
analytical or descriptive. Analytical
studies feature a comparison (control) group, whereas descriptive studies do not. Within analytical studies,
cohort studies track people forward in
time from exposure to outcome. By
contrast, case-control studies work in
reverse, tracing back from outcome to
exposure. Cross-sectional studies are
like a snapshot, which measures both
exposure and outcome at one time
point. Descriptive studies, such as
case-series reports, do not have a
comparison group. Thus, in this type
of study, investigators cannot examine
associations, a fact often forgotten or
ignored.
Early clinical ground breaking
studies in implant dentistry were
large descriptive studies with variable length of follow-up. They established the positive clinical outcomes
of modern osseointegrated implants.
The
need
for
comparative
research was soon established to
answer some relevant questions. In
recent years, there has been an
increase in the publications reporting
results from RCTs and this has provided much stronger evidence for
these treatments. Although a high
quality RCT is rightly considered the
gold standard, it may not be able to
answer all the important questions
and therefore there is much to be
gained from observational studies,
i.e. where there is no experimental
assignment of the intervention or
exposure. Observational studies are
2012 John Wiley & Sons A/S

particularly useful in dealing with

rare or late events and may relate
well to clinical practice and allow
generalizability to large patient
groups. In addition, large and properly designed analytical observational
studies have the ability to robustly
identify and measure risk factor associations on implant related outcomes.
This is something that RCTs are
unlikely to achieve due to practical
reasons. However, it should also be
recognized that observational studies
are always at greater risk of bias and
the eects of confounding than well
designed RCTs.
The descriptive study (case series)
is still the most frequently reported
design in this eld; its key characteristic is that it consists of a single
group of subjects. These may be
longitudinal (prospective or retrospective) or cross-sectional in
design.
Frequently,
dierent
study
designs are employed sequentially in
the generation of clinically relevant
evidence for a specic treatment
modality or risk factor. Case series
are often the starting point: they
document the performance of a new
procedure, device or biological and
provide key data for the proper
planning of the necessary experimental research. The lack of a comparison group severely limits the
conclusions beyond the proof of
principle and hypothesis generation
stage. The need to answer comparative questions in terms of ecacy
requires the use of experimental
research, and randomized controlled
clinical trials in particular. These are
also
frequently
performed
in
sequence (so called phase IIV studies or pre- and post-market trials).
In parallel to experimental research
and frequently based on hypotheses that emerge during the conduct
of previous trials (RCT) or clinical
observations (case series) properly
designed observational research provides important dimensions to the
clinical application of the treatment
under investigation. These include
knowledge of local (e.g. bone or soft
tissue quantity, quality and position,
plaque control) and patient based (e.
g. tobacco exposure, medications,
presence and control of co-morbidities like periodontitis or diabetes)
characteristics that may modify
prognosis and treatment decisions.

75

In implant dentistry, the need to

focus on RCTs has been discussed in
previous workshops (2005 and 2008)
but, in general, less attention has been
paid to non-experimental designs.
Clinical Performance/Descriptive
Research in Implant Dentistry (Meijer
& Raghoebar 2012)
Critical aspects in design and potential
sources of bias in case series research

There is confusion of terminology in

observational studies; e.g. case series
are often called cohort studies. The
majority of studies in implant dentistry deal with the description of a
collection of patients in which a certain treatment has been carried out.
The patients are followed for a designated amount of time and a number of items are collected at certain
evaluation points. These studies,
either prospective or retrospective,
are sometimes referred to as cohort
studies, but they should be more
appropriately called case series.
These are descriptive studies.
However, it is important to know
that results of case series have served
and can serve as a basis for hypothesis-generation and future research.
In addition, case series can still be
informative for objectives, such as
the initial evaluation of a new technique or device.
Although selection biases are
higher in case series, eorts should
be made to address and limit potential sources of bias. For example,
they should dene and describe the
study setting, location, period and
method of recruitment, follow-up
time, inclusion and exclusion criteria,
and source of participant selection.
Issues related to funding should also
be addressed.
Assessment of research reporting of
descriptive studies

To assess quality of reporting of

descriptive studies, the STROBE
Statement (2008) should be used. In
implant dentistry it should be noted
that:
During the last 20 years the number of descriptive studies has
increased and the quality of
reporting has improved. In 2010,
70% of STROBE items were

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Tonetti et al.

properly addressed, as opposed to

46% in 1990
Improper
reporting
primarily
includes items in title & abstract,
methods and source of funding

Priority areas for improvement of study

design and reporting

Items that need to be improved

related to study design of case series
include:
Proper denition of exposures and
potential confounders
Proper denition of outcomes
Patient selection criteria and characteristics
Items that need to be improved
related to study reporting include:
A description of any eorts to
address potential sources of bias
An explanation of how the study
size was determined
The indication of the studys
design with a commonly used
term in the title or abstract
The reporting of the length of follow-up
Reporting numbers of subjects
and their reasons of loss to follow-up at each stage of the study
Reporting patient characteristics
(demographic, clinical & social)
Reporting on exposures and
potential confounders
Reporting of source of funding
Reporting on ethical committee
approval
It is recommended that authors
and journals embrace the STROBE
Statement to improve quality of
reporting of descriptive studies.
Prognostic & Risk Factor Research
in Implant Dentistry (Rocchietta &
Nisand 2012)
Critical aspects of design and potential
sources of bias

Although data derived from descriptive studies (case series) is useful in

hypothesis generation, this research
design is not suitable to provide
evidence for identifying exposures
associated with dental implant outcomes. Data derived from specic
analytical designs are necessary to

provide robust measures of association and to ascertain causality.

Although it is recognized that the
evidence generation process does not
rely on one type of study, two
observational study designs are particularly useful to expand knowledge
on risk factors in implant dentistry:
the case control study and the
cohort study. Each has its advantages and limitations, but for their
results to be valid, they require specic steps to be taken to control
potential bias.
Case-control studies
Case-control studies are useful for
scenarios where disease incidence is
rare or the time period between the
exposure and manifestation of disease is long.
The critical issues in study design
for case control studies are:
Selection of the control group.
Every eort should be made to
match the cases with a suitable
control by means of individual/
paired matching or group matching (using the appropriate statistics). Although it is recognized
that the cases and the controls will
never be perfectly identical, some
aspects of matching seem to be
critical for the validity in implant
dentistry. As an example, cases
with implant loss should be
matched with controls with a similar length of exposure time of
loading. Selection criteria for both
cases and controls should be
clearly reported. Other confounding variables that cannot be
matched should be adjusted for
(as far as possible), using appropriate statistical methods.
Minimize the biases in the ascertainment of exposure level also
known as recall bias and clinical
outcomes (i.e. inaccurate reporting
of a past exposure)
Minimize the participation bias (i.
e. people who agree to participate
in the study may be dierent from
those who refuse to in term of
their exposure status)
Sample size calculation should be
undertaken a priori to ensure that
the study has adequate statistical
power to detect a clinically relevant risk and to correctly interpret
negative results

Cohort studies
The main feature of a cohort study
is observation of large numbers of
subjects over a long period (commonly years), with comparison of
incidence rates in groups that dier
in exposure levels. The alternative
terms for a cohort study are followup, longitudinal and prospective
studies. A cohort is a representative
sample of a dened population (e.g.
partially edentulous patients receiving dental implants).
The critical issues in study design
for cohort studies are:
To minimize the bias in the
selection of the cohort population (participation/selection bias,
i.e. people who agree to participate are dierent from those
who refuse to in terms of the
propensity for developing the disease). Description of the recruitment criteria should be clearly
reported
Appropriate statistical methods
should be used to address the
potential imbalance in confounding variables
Sample size calculation should be
undertaken to ensure that the
study has enough statistical power
to detect a clinically relevant
increase in risk and to correctly
interpret negative results
Accuracy of measurement of the
exposure and incidence of the disease outcome will determine the
required sample size and the period of observation time
Stability of measurement of the
outcome or exposure over time. (i.
e. changes in examiners or
changes of instruments used
throughout the study)
The issue of subjects lost to follow-up must be addressed in the
following manner; (i) the percentage should be reported, (ii) the
cause for the dropout should be
highlighted (iii) the treatment of
missing value for dropout patients
should be reported. If missing values are imputed, then the method
of imputation should be reported
(iv) an assessment of the subgroup
that have dropped out needs to be
evaluated (baseline and longitudinal data should be compared with
the non-dropouts to explore
biases)
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Clinical research in implant dentistry

Assessment of current research and
research reporting

Of 104 identied papers dealing with

diabetes/smoking/periodontitis
as
risk indicators for implant loss, three
cohort studies and no case control
were identied (Rocchietta & Nisand
2012). Most of the papers found were
case series either retrospective or prospective, even in cases where the terminology case control or cohort
was mentioned in the title and
abstract. The vast majority of the
papers explored the associations
between outcomes and exposures/
attributes as secondary analyses.
Two major problems were associated with the assessment of exposure: (i) inconsistency in the way of
reporting and (ii) lack of reliable
measurement of the exposure (i.e.
use of patient reported data instead
of objective biochemical markers).
Priority areas for improvement of study
design and reporting

There is an urgent need for well

designed, performed, analysed, interpreted and reported case controls and
cohort studies. These have the potential to provide more robust new
knowledge that has profound patient
care implications. The association/
eect of exposures or attributes, such
as cigarette smoking, diabetes, previous periodontitis, bone quality, bone
quantity, are examples of conditions
that may be hard to study using only
randomized controlled clinical trials.
Among other issues clinical
researchers in implant dentistry may
want to consider:
Collaboration with experts to
design, analyse and interpret studies is highly recommended
An improved matching of the
controls to minimize the dierences in the distribution of confounding factors between cases
and controls
Improving statistical analyses to
account for confounding variables
Study design should include prior
sample size calculation
Dropouts should be recorded in
the results and the statistical analyses should account for them
A well-dened measurement of
exposure and assessment of outcome should be adopted
2012 John Wiley & Sons A/S

Intra- and inter-examiner calibration and reproducibility

Comparative Research, Randomized

Clinical Trials in Implant Dentistry
(Cairo et al. 2012)
Critical aspects of design and potential
sources of bias in implant dentistry

The majority of RCTs were conducted in single centres (83%),

whereas the remaining (17%) were
multicentre. The parallel design,
where each participant is randomly
assigned to a group and receives the
same type of intervention, was the
most frequent RCT type (65%), followed by split-mouth design (24%),
crossover design (4%) and factorial
(1%).
In the position paper (Cairo et al.
2012), bivariate analyses showed that
parallel or split-mouth studies were
associated with less probability to
identify a statistically signicant difference between groups for the primary outcome variable (p < 0.0002)
compared with the other types of
study design. This nding suggests
that randomized parallel and splitmouth designs were the most rigorous
designs in implant dentistry. It is reasonable to hypothesize that it is easier
and less time consuming to select
patients with a single defect (i.e.,
missing a single tooth) than patients
with bilateral homologous defects to
plan a split mouth study. Furthermore, the increased eciency of a
split mouth design reduces the sample
size (number of patients), the smaller
sample size reduces the external validity and generizability of the results.
More frequently, RCTs showed a
superiority design (88%), aimed to
demonstrate that one treatment is
more eective than another. Very
few studies (7%) showed a non-inferiority design, aimed to show that
the eect of the treatment is at least
as good as that of the control
(Blackwelder 2004). The residual 5%
showed an equivalence design, a trial
constructed to demonstrate that an
experimental treatment is similar to
a control treatment (Jones et al.
1996).
A low number of RCTs declared
operator (21%) and institution (2%)
experience in experimental procedures: this information is really

77

important especially for trials dealing with surgical procedures where

a learning curve is generally necessary to obtain good clinical outcomes. Initial training cases (i.e.
using cases series studies) could be
considered for testing new technologies/new
surgical
approaches.
Furthermore, expertise based RCTs
could be considered for specic
areas
of
implant
dentistry
(Devereaux et al. 2005). There were
multiple sources of potential bias
that appeared to impact studies in
implant dentistry.
Correct allocation concealment
was described in only 22% of studies, only 37% showed a random
sequence generation at low risk of
bias, 12% performed a correct sample size calculation, the examiner
was masked in 42% of studies when
blinding was feasible, and only 9%
adhered to CONSORT statements.
Bivariate analyses showed that several sources of bias were signicantly
associated with rejection of the null
hypothesis. These included: inadequate
allocation
concealment
(p = 0.0125), lack of information on
dropouts (p = 0.0318) and failure to
adhere to CONSORT statement
(p = 0.0333).
Assessment of current research and
research reporting

In the eld of implant dentistry, it

has been very encouraging to see
increasing numbers and quality of
reporting of RCTs. Notably, during
the years of 20062011, 59% of the
total RCTs in the implant dentistry
eld have been published.
Over the years, ethical board
approval and informed consent
obtainment
have
signicantly
improved (p < 0.0001 for each). In
terms of study quality: metrics associated with bias, reporting, sample
size calculation and statistical analysis reporting improved over the years
(Cairo et al. 2012).
Priority areas for improvement of study
design and quality of reporting

Key priority areas to improve quality of reporting of RCTs incorporate

dierent items including:
Adequate sample size calculation
with a resulting number of patients

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Tonetti et al.

allocated to experimental procedures performed a priori

Incorporation
of
appropriate
patient-reported outcomes
Proper randomization and allocation concealment (i.e. central
allocation, computer-generated randomization, etc)
Blinding of examiners, whenever
possible
Appropriate statistical analysis with
the patient as the statistical unit,
using one implant for one patient,
mean value for each patient, random eect models or multilevel
models. For multicentre studies the
centre eect needs to be considered.
Information on dropouts and possible reasons related to missing
patients at the last follow-up

Priorities to reduce bias in experimental studies

A number of recommendations
should be implemented to reduce
bias in RCTs dealing with implant
dentistry. These include:
Consideration of non-inferiority/
equivalence designs in addition
to superiority study design for some
types of comparisons. For example,
the non-inferiority design is valuable when the primary outcome may
be similar between the treatment
and control groups, but the treatment may cost less or be easier to use
Clinical trial registration at study
initiation
Inclusion of study monitoring to
improve overall study quality is
encouraged
Using the intention to treat analysis as appropriate to manage drop
outs if/when they occur
Adherence to CONSORT statements (with emphasis on the surgical extension of the CONSORT
statement)

Outcome Assessment and Analysis

in Implant Dentistry (Needleman
et al. 2012)
Rationale for currently used outcome
measurements focussed on implant
survival and success

The rationale for any medical intervention, including implant-supported

prosthetic rehabilitation, is to main-

tain or improve patients well-being

(e.g. quality of life) that has been
challenged by a disease, condition or
disability. Thus, outcome measurements related to implant-supported
rehabilitation cannot be limited to
implant survival or success rates, but
when appropriate should also
include the functional performance
and aesthetic aspects of the entire
rehabilitation as well as the health
status of peri-implant tissues. Assessment should also include patientreported outcomes.
Implant survival rate has been
used as a primary outcome measurement throughout the years because it
provides long-term data on the predictability/validity of osseointegration, with respect to dierent patient
characteristics, clinical conditions
and medical devices. In this respect,
it should be noted that whilst
implant survival has remained the
most commonly used implant outcome throughout the modern era of
dental implant research, its prevalence has reduced over time from
 70% in 19801994 to 53.6% in
20102011.
Implant success rate was less
commonly employed, but was still
present in just over half of studies
(either as primary or secondary outcome). Implant success constituted a
wide variety of composite or single
outcomes with little or no consistency between studies. In general,
implant success rates are usually
based on clinical and/or radiological
parameters related with the remodelling/loss of the implant-supporting
bone as well as the disease status of
the peri-implant soft tissues. Measuring the time-dependent bone level
change around implants is used to
provide information on the eect of
occlusal load or diagnose mucositis/
peri-implantitis conditions. Probing
measures are used to dene the
healthy/diseased conditions of the
peri-implant tissues.
Limitations of current measures of
performance

Implant survival Limitations:

The presence or absence of the
implant in the patients mouth per
se may not be associated with the
maintenance or re-establishment
of the patient well-being (psycho-

social characteristics and quality

of life, absence of disease, function, aesthetics)
Lack of consensus of how to
dene implant survival (e.g. how
to handle an implant that has
completely lost osseointegration,
but is still retained in place by the
restoration or is non-restorable)
The reported high survival rates
require large sample size and/or
long-term follow-up for clinical
research
Implant success Limitations:
Lack of consensus in the denition
of success for implant therapy
Lack of consensus in the choice of
outcomes to measure implant success
Validity and relevance of the outcome measures (e.g. diculty in
measuring probing depth)
Lack of clarity of characteristics
of study or reference groups
Variation in the timing of outcome assessment (e.g. timing of
baseline observation)
Lack of details in reporting

Best practice in analytical methods

Methods should account for

clustering of measurements (e.g.
sites
around
implants)
and
implants (e.g. multiple implants
within the restoration and the
patient). This will allow a more
appropriate estimation of both the
clinical performance of implants
and the relationships between risk
factors at dierent levels (e.g.
implant versus patient level)
Using contemporary statistical
methods to account for censoring
(where implant loss will not have
occurred to all participants within
the period of study, and/or
patients will have been lost to follow-up). Recommended methods
of such time-to-event or survival
analyses are well documented
Studies need to report the statistical analysis properly to provide
readers with sucient information
to evaluate the clinical signicance
of the results. For example, condence intervals should be reported
in connection with regression coefcients and shown on survival
plots; assumptions underlying the
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Clinical research in implant dentistry

statistical models, such as proportionality in Cox models for survival
analysis, should be evaluated
Clarity of characteristics of study
or reference groups

Reasons for lack of consensus

The issue of outcome choice and

measurement in dental implant
research has been long debated and
relatively little progress has been
made. This may be due to:
Dierences in implant design, prosthetic supra-structure and treatment
protocol (variations in pre-surgical
anatomical conditions, surgical
technique, timing of occlusal loading, etc.) provide an explanation for
dierences in the methodology for
outcome assessment
Dierent
opinions
on
the
aetiology of peri-implant disease
conditions
and
reasons
for
implant loss
The relationship between surgical
and prosthodontic provision of
treatment
placing
dierence
emphasis on outcome measures
Lack of validity and relevance of
the outcome measures
Lack of universally accepted
guidelines (what, where, how,
when and who measure)
Guideline
development
and
knowledge transfer and implementation have not followed recommended best practice

Consequences of lack of consensus

Dicult to design, conduct and

interpret studies
Dicult to compare and synthesize the results within and between
studies
Lack of clear standards for quality assessment of new devices or
protocols
Delay application of knowledge
and innovation for clinical practice
Dicult to identify best care

Characteristics of ideal outcomes

Relevant to treatment goals, especially including patient reported

outcomes
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Applicable to great majority of

implant
designs,
restorations,
patients and conditions
Clear, well dened, easy to use
and validated
High sensitivity/specicity for disease diagnosis and disease progression
Amenable to commonly used statistical methods
Applicable and ethical in the clinical practice
Universally accepted

Which dimensions/disease definitions

should ideal outcome(s) capture?

The major goal of the implant-supported rehabilitation is patient wellbeing. This includes quality of life,
oral health, proper function and
acceptable aesthetics. Thus, ideal
outcomes should capture aspects
directly related with this treatment
goal.
Practical considerations for eventual
widespread adoption of a minimum set of
reported outcomes

Stakeholder involvement in development, ownership, dissemination and

implementation is necessary. These
stakeholder groups include patients,
professionals, providers of education, health-policy makers, scientic
communities, industry and funding
agencies. There are established pathways to manage these aspects. Adoption of ideal outcomes should be
encouraged in undergraduate and
post-graduate education programs as
well as in Continuing Education.
Proposal of a set of outcome domains for
clinical research in implant dentistry

During the VIII EFP Workshop, a

questionnaire survey on priorities of
implant treatment outcomes was
conducted among the workshop
participants. These indicated that
outcome measures should capture
patient reported outcomes (McGrath
et al. 2012), peri-implant health
(Derks and Tomasi 2012, Graziani
et al. 2012) and restoration outcomes (Pjetursson & Lang 2012, Benic et al. 2012). As a result of
responses and deliberation of WG2,
the following outcome domains were
identied:

For patient-reported
measures

79

outcome

Health-related quality of life

General satisfaction
For peri-implant health
Marginal bone level
Tissue inammation (BOP)
Probing depth (probing from
reference point)
For implant-supported restoration
Longevity of the restoration

Function/occlusion related
outcomes
Technical complications
For the assessment of periimplant health, signicant validation
of single outcomes and their measurement systems has been performed and reviewed in previous
workshops (Lindhe et al. 2008, Lang
et al. 2011). These, together with the
peri-implantitis case denition provided by group IV of this workshop
(Sanz et al. 2012), allow the introduction of a set of success criteria
related to this domain. Harmonization of measurement techniques and
outcome reporting will improve comparability between studies and
research synthesis. More work is
needed for the other domains (Lang
& Zitzmann 2012).
Conclusions

In spite of important progress in

recent years, some clinical research
in implant dentistry remains at high
risk of bias. Conclusions continue to
be made based on inappropriate
research designs this is particularly
true in observational type research.
Properly
designed,
executed,
analysed, interpreted and reported
observational research is needed to
expand the body of evidence in areas
such as risk factor research that
are not likely to benet from randomized clinical trials. STROBE
guidelines for reporting of observational research must be adhered to.
In risk factor research, objective
measures of exposure need to be
employed. Establishment of an
implant failure registry could provide a key resource.

80

Tonetti et al.

Current emphasis on evidence

generation with randomized clinical
trials should continue. Notwithstanding recent success with eorts
to reduce bias and improve reporting, eorts on quality improvement
must continue. CONSORT guidelines for reporting of randomized
clinical trials must be adhered to.
Non-inferiority designs may prove
benecial in introducing clinically
meaningful innovation.
To overcome the present state of
confusion, clinical research in
implant dentistry should consider
three outcome domains: patient
reported outcome measures, periimplant tissue health and outcomes
related to implant supported reconstructions. Peri-implant tissue health
can be measured by marginal bone
level changes (radiographic measurements) and tissue inammation
(bleeding on probing and pocket
depth) and incorporated in the time
to event analyses. More research is
needed for the other domains.
Research on outcome measure
domains, how to measure them and
perhaps how to integrate them into
a useful composite indicator is an
area of top priority and should
urgently inform a proper process
leading to a consensus on outcome
measures.

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Address:
M. Tonetti
European Research Group on Periodontology
E-mail: maurizio.tonetti@ergoperio.eu

2012 John Wiley & Sons A/S