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Tonetti 2019 - Consesous Extraction Socket Timing

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0% found this document useful (0 votes)
102 views12 pages

Tonetti 2019 - Consesous Extraction Socket Timing

Uploaded by

Alex Millan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Received: 18 April 2019 | Accepted: 3 May 2019

DOI: 10.1111/jcpe.13131

SUPPLEMENT ARTICLE

Management of the extraction socket and timing of implant


placement: Consensus report and clinical recommendations of
group 3 of the XV European Workshop in Periodontology

Maurizio S. Tonetti1,2 | Ronald E. Jung3 | Gustavo Avila-Ortiz4 | Juan Blanco5 |


Jan Cosyn6 | Stefan Fickl7 | Elena Figuero8 | Moshe Goldstein9 |
Filippo Graziani10 | Phoebus Madianos11 | Ana Molina8 | Jose Nart12 |
Giovanni E. Salvi13 | Ignacio Sanz-Martin8 | Daniel Thoma3 | Nele Van Assche14 |
Fabio Vignoletti8
1
Division of Periodontology and Implant Dentistry, Faculty of Dentistry, University of Hong Kong, Hong Kong, China
2
European Research Group on Periodontology, Genova, Italy
3
Clinic of Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich, Zurich, Switzerland
4
Department of Periodontics, The University of Iowa, Iowa City, Iowa
5
Department of Surgery and Medical-Surgical Specialties (Dentistry area), Unit of Periodontology, University of Santiago de Compostela, Santiago, Spain
6
Department of Dentistry, University of Ghent, Ghent, Belgium
7
Division of Periodontology, University of Würzburg, Würzburg, Germany
8
ETEP (Etiology and Therapy of Periodontal Diseases) Research Group, Department of Dental Clinic Specialties, Faculty of Dentistry, University Complutense,
Madrid, Spain
9
Department of Periodontology, Hebrew University, Jerusalem, Israel
10
Sub-Unit of Periodontology, Halitosis and Periodontal Medicine, Department of Surgical, Medical and Molecular Pathology and Critical Care
Medicine, University of Pisa, Pisa, Italy
11
Department of Periodontology, Kapodistrian University, Athens, Greece
12
Department of Periodontology, Universitat Internacional de Catalunya, Barcelona, Spain
13
Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland
14
Private Practice of Periodontology and Implantology, Geel, Belgium

Correspondence
Maurizio S. Tonetti, Periodontology, Faculty Abstract
of Dentistry, Hong Kong University, Prince Background: The transition from a tooth requiring extraction to its replacement (with
Philip Dental Hospital, 34 Hospital Road,
Hong Kong, China. a dental implant) requires a series of clinical decisions related to timing, approach,
Email: tonetti@hku.hk materials, cost-­effectiveness and the assessment of potential harm and patient pref-
Funding information erence. This workshop focused on the formulation of evidence-­based consensus
Funds for this workshop were provided by
statements and clinical recommendations.
the European Federation of Periodontology
in part through an unrestricted educational Methods: Four systematic reviews covering the areas of alveolar ridge preservation/
grant from Geistlich Pharma AG.
bone grafting, immediate early and delayed implant placement and alveolar bone
augmentation at the time of implant placement in a healed ridge formed the basis of
the deliberations. The level of evidence supporting each consensus statement and its
strength was described using a modification of the GRADE tool.
Results: The evidence base for each of the relevant topics was assessed and sum-
marized in 23 consensus statements and 12 specific clinical recommendations. The

J Clin Periodontol. 2019;46(Suppl. 21):183–194. wileyonlinelibrary.com/journal/jcpe © 2019 John Wiley & Sons A/S. | 183
Published by John Wiley & Sons Ltd
184 | TONETTI et al.

group emphasized that the evidence base mostly relates to single tooth extraction/re-
placement; hence, external validity/applicability to multiple extractions requires care-
ful consideration. The group identified six considerations that should assist clinicians
in clinical decision-­making: presence of infection, inability to achieve primary stability
in the restoratively driven position, presence of a damaged alveolus, periodontal phe-
notype, aesthetic demands and systemic conditions.
Conclusions: A substantial and expanding evidence base is available to assist clini-
cians with clinical decision-­making related to the transition from a tooth requiring
extraction to its replacement with a dental implant. More high-­quality research is
needed for the development of evidence-­based clinical guidelines.

KEYWORDS
alveolar ridge preservation, bone grafting, clinical guidelines, dental implant, evidence-based
dentistry, implant performance, implant placement/timing, implant survival, tooth extraction

1 | I NTRO D U C TI O N
Clinical Relevance
The WHO oral health databank has shown important progress Scientific rationale for the study: Clinical decisions on how
in tooth retention over a 20-­year period (Kassebaum et al., 2014). to best transition from a tooth requiring extraction to its
Tooth extraction due to disease and/or trauma, however, remains a implant replacement require the consideration of a wide
frequent occurrence leading to the indication of tooth replacement, range of evidence.
such as an implant-­supported fixed dental prosthesis. Principal findings: The discussions of this workshop were
It is important to underline that, in the vast majority of cases, informed by four specifically commissioned systematic
dental extraction is indicated due to severe disease or trauma that reviews. The evidence was graded, and consensus state-
has led to irreparable damage to the tooth and/or its supporting ap- ments were formulated along with clinical recommenda-
paratus. Different clinical scenarios with varying extent and patterns tions. A substantial body of evidence is available to guide
of residual alveolar bone, therefore, may be encountered. Hence, a clinicians in making evidence-­based decisions.
careful examination should be carried out before and immediately Practical implications: In their decision-­making process,
after tooth extraction in order to assess the applicability of different clinicians should pay particular attention to the presence
therapeutic strategies, which may involve implant placement. of infection, inability to achieve primary stability of the
Noteworthy, the decision to extract a tooth is intricately con- implant in the restoratively driven position, presence of a
nected with thought processes related to its replacement, the as- damaged alveolus, periodontal phenotype, aesthetic de-
sessment of the evidence pertaining to available treatment choices mands and systemic conditions.
for both its retention and replacement, the cost-­benefit profile of
the available options and, ultimately, individual preferences of the
patient and the treating clinician.
Following tooth extraction, a series of physiological changes af-
fecting the alveolar bone that surrounds the extraction socket take
place (Sculean, Stavropoulos, & Bosshardt, 2019). These include
bone formation in the socket as well as volumetric resorption lead-
ing to changes in the dimensions and contours of the alveolar ridge.
A previous meta-­analysis found that average reductions of 3.87 mm
(95% CI: −4.059 to −3.673) in the buccolingual ridge thickness and a
vertical mid-­buccal resorption of 1.67 mm (95% CI: −1.910 to −1.428)
are to be expected following unassisted socket healing (van der
Weijden, Dell'Acqua, & Slot, 2009). Attempts to limit bone resorp-
tion, shorten the overall treatment time and maximize therapeutic
predictability have led to the development of five documented ap-
proaches that differ depending on variations in the management of
TONETTI et al. | 185

F I G U R E 1 Diagrammatic representation of the different options for implant replacement after tooth extraction. Please note the two
procedures that are performed at the time of tooth extraction and the other three that are performed at a later time. ARP, alveolar ridge
preservation. The figure illustrates the five different options, numbered 1–5, available after tooth extraction to transition towards an implant
supported restoration. Two interventions, immediate implant placement and alveolar ridge preservation (ARP), are performed at the time of
tooth extractions. Three additional options are available following different degrees of healing after the extraction: early soft tissue healing,
partial bone healing and full bone healing. All options can theoretically be performed with or without the addition of bone regeneration.
The figure also illustrates the four types of implant placement: type 1 (immediate, 0–1 week), type 2 (early, 4–8 weeks), type 3 (delayed,
3–4 months) and type 4 (standard placement in a healed ridge, >4 months). The diagram introduces type 3* and type 4* implant placement:
this refers to implant placement in a ridge that has been preserved and the 3* or 4* classification refers to the duration of healing of the ARP
procedure before implant placement. Please see text for additional details

the extraction site and the timing of implant placement. These ap- • A delayed implant placement protocol, characterized by implant
proaches are illustrated in Figure 1 and include the following: placement after completion of soft tissue healing, and after the
majority of the alveolar bone healing and profile and dimensional
• A conventional treatment protocol involving tooth extraction and changes have taken place, which usually occurs at 12–16 weeks
unassisted healing of the extraction site for a period of >16 weeks, following tooth extraction. This has been termed as type 3 im-
followed by implant placement in a healed ridge. This approach plant placement.
has been termed type 4 implant placement.
• A conventional protocol modified by performing an interceptive The different treatment modalities illustrated in Figure 1, which have
procedure to minimize the dimensional changes that take place after been described in the literature and in the systematic reviews used as
tooth extraction, followed by implant placement 12–16 weeks later. a basis for the deliberation at the workshop, are reflective of a variable
This approach has been called alveolar ridge preservation (ARP), and degree of scientific and clinical validation (Gallucci, Hamilton, Zhou,
it represents a modified type 3 or type 4 implant placement (further Buser, & Chen, 2018). Accounting for different levels of validation is
referred as Type 3* or Type 4* based on time of implant placement). an important component of the background knowledge necessary for
• An immediate implant placement protocol, characterized by implant clinical decision-­making.
placement at the time of or shortly after tooth extraction (<10 days In clinical practice, the choice between the aforementioned implant
after extraction), which is known as type 1 implant placement. placement modalities has been empirically based on the assumption
• An early implant placement protocol, characterized by implant that the presence/absence of an intact residual ridge or socket walls
placement after completion of the majority of soft tissue healing, is an indication for specific approaches. Evidence from comparative
but before the occurrence of complete bone maturation and ridge studies has, so far, played relatively little role in clinical decision-­making
profile modification (4–8 weeks after tooth extraction, type 2 im- processes. This group of the workshop focused on summarizing the
plant placement) scientific evidence in specific consensus statements and on providing
186 | TONETTI et al.

clinical recommendations relevant to these therapeutic alternatives. and that none of the RCTs exhibited a low risk of bias, which calls for
Table 1 illustrates the modified GRADE criteria used to describe the caution when interpreting these findings. Due to the high degree of
level of available evidence and the strength of the statements/clinical clinical heterogeneity that exists between the majority of trials in-
recommendations (Guyatt et al., 2011; Tonetti & Jepsen, 2014). cluded, the conduction of a network meta-­analysis was not justified.

2 | E FFEC T O F A LV EO L A R R I D G E 2.2 | External validity of the findings


PR E S E RVATI O N I NTE RV E NTI O N S
The statements on ARP-­SG in this consensus report are primarily
FO LLOW I N G TO OTH E X TR AC TI O N : A
applicable to adults who require a single extraction in tooth-­bound
S YS TE M ATI C R E V I E W A N D M E TA-­A N A LYS I S
sites that exhibit substantial socket wall integrity after extraction,
regardless of smoking status. Reasons for extraction may include
2.1 | Preamble
catastrophic tooth fractures, extensive caries and endodontic fail-
Tooth extraction triggers a sequence of biologic events that typically ure. A word of caution is needed with regard to tooth loss due to
result in the horizontal and vertical reduction in alveolar ridge dimen- severe periodontitis, as very limited residual bony walls may be avail-
sions, and subsequent changes in its profile, which may interfere with able for worthwhile ridge preservation.
further therapy. ARP is frequently indicated to attenuate these physio-
logic dimensional changes (Avila-­Ortiz, Chambrone, & Vignoletti, 2019).
2.3 | Consensus statements
The aim of this systematic review was to critically analyse the
available evidence on the effect of different modalities of ARP as
2.3.1 | What is the effect of alveolar ridge
compared to tooth extraction alone. ARP interventions were de-
preservation via socket grafting on ridge dimensions?
fined as filling the socket with a biomaterial (Alveolar ridge preser-
vation via socket grafting [ARP-­SG]), socket sealing (SS) through the Alveolar ridge preservation via socket grafting attenuates the
sole application of a barrier material (autogenous or exogenous) or a physiological bone dimensional changes that typically follow tooth
combination of both, either involving primary intention healing fol- extraction.
lowing flap advancement or secondary intention healing. Outcomes (Evidence Level 1: systematic review of RCTs, 18 RCTs and 612
were organized in three main categories: clinical, radiographic and subjects)—(Strength of statement: high).
patient-­reported outcome measures (PROMs). Alveolar ridge preservation via socket grafting may prevent
The systematic review included 25 articles from a total of 22 RCTs. 1.5–2.4 mm of horizontal, 1–2.5 mm of vertical mid-­buccal and 0.8–
Sufficient data were available to perform 18 meta-­analyses com- 1.5 mm of mid-­lingual vertical bone resorption as compared to tooth
paring five different ARP-­SG treatment modalities to the control (un- extraction alone.
assisted socket healing). (Evidence Level 1: meta-­analysis of systematic review of RCTs,
Potential limitations of this systematic review are the low num- 14 RCTs and 676 subjects). (Strength of statement: high).
ber of studies included in some of the subcategory meta-­analyses

2.3.2 | How do different alveolar ridge preservation


TA B L E 1 Specific modified GRADE criteria used to describe the modalities compare in terms of their effect on ridge
level of evidence and the strength of a clinical statement
dimensions?
Level of evidence Definition criteria
In spite of the presence of multiple studies comparing a variety of
Level 1 Systematic review with meta-­analysis bone grafts and SS approaches, it was not possible to identify an
Level 2 Systematic review without meta-­analysis, ARP approach associated with superior outcomes. This finding does
single multicenter RCT, multiple RCTs not imply that any bone grafting and/or SS material unfailingly brings
Level 3 Single RCT, RCTs designed for different a therapeutic benefit, as only few materials are appropriately docu-
reason
mented. The reader is referred to the original systematic review for
Level 4 Case series, CCTs
a detailed compilation of the evidence for individual ARP treatment
Level 5 Expert opinion modalities and grafting materials.
Strength of (Evidence Level 2: systematic review without network meta-­
statement Definition criteria analysis, 22 RCTs and 730 subjects)—(Strength of statement: moderate).
High High level of confidence: low risk of bias,
adequate number of subjects and trials,
negligible heterogeneity 2.3.3 | What is the impact of buccal bone thickness
Moderate Good confidence, some risk of bias, heteroge-
on dimensional changes?
neity, adequate number of subjects and trials
Sites presenting a thick buccal bone (e.g. >1.0–1.5 mm) exhibit less
Low Not confident, high risk of bias, uncertainty
alveolar ridge dimensional changes after tooth extraction. It has also
TONETTI et al. | 187

been observed that the application of ARP-­SG is more beneficial in compartment and/or assist soft tissue healing. Socket sealing can be
sites exhibiting thin buccal bone. achieved either with or without primary soft tissue closure.
(Evidence Level 2: systematic review without meta-­analysis, five
RCTs and 212 subjects). (Strength of statement: moderate).
2.4.3 | How much healing time following
ARP therapy is recommended prior to implant
2.3.4 | What is the effect of alveolar ridge placement?
preservation—Socket Grafting on the feasibility of
A minimum healing time that allows for sufficient bone formation,
implant placement without a second augmentation?
typically 3–4 months, is recommended. An extended healing time
The feasibility of implant placement without simultaneous ancillary may be required on the basis of the phenotypic characteristics of the
grafting is higher in sites that have received ARP-­SG, but additional extraction site, the properties of the biomaterial(s) used and patient-­
bone augmentation at the time of implant placement may be re- specific systemic factors.
quired after both ARP-­SG and unassisted socket healing.
(Evidence Level 2: systematic review of RCTs without meta-­analysis,
2.5 | Recommendations for future research
five RCTs and 214 subjects) (Strength of statement: moderate).
There is a need to conduct well-­designed RCTs involving multiple
arms that would allow for direct comparisons of different ARP mo-
2.3.5 | What is the performance of implants
dalities of therapy, including socket grafting and sealing materials,
inserted at sites with alveolar ridge preservation?
in different clinical scenarios (e.g. single-­ vs multi-­rooted sites; dam-
Sites that received ARP-­SG exhibit no differences compared with aged vs intact sockets). Relevant endpoints of interest that go be-
sites that underwent unassisted socket healing in terms of implant yond conventional linear clinical and radiographic assessments, such
loss and implant success after a minimum of 12 months of functional as bone and soft tissue volumetric dimensional changes, implant-­
loading with the final prosthesis. related outcomes and PROMs, should be considered. Additionally,
(Evidence Level 2: systematic review of RCTs without meta-­analysis, these studies should incorporate properly described, reproducible
three RCTs and 95 subjects). (Strength of statement: moderate). methods for assessment of outcomes of therapy that would allow
for external validation, cost-­benefit analyses and the performance of
robust meta-­analyses.
2.4 | Clinical recommendations
Future research should elucidate the influence of local and sys-
temic patient-­specific factors on the outcomes of ARP therapy (e.g.
2.4.1 | When should clinicians consider ARP
presence of concomitant pathology, soft tissue thickness, kerati-
following tooth extraction?
nized mucosa width, smoking, history of periodontitis and uncon-
Clinicians should consider ARP in clinical scenarios in which minimiz- trolled systemic conditions that may play a role in intra-­oral bone
ing alveolar ridge dimensional changes is critical, such as and soft tissue healing).

• Extraction sites in areas of aesthetic priority, both when an implant-sup-


3 | THE EFFECTIVENESS OF IMMEDIATE
ported and a tooth-retained (e.g. pontic site) restoration is planned.
IMPLANT PLACEMENT FOR SINGLE TOOTH
• Extraction sites on which major ridge reduction is expected and
REPLACEMENT COMPARED TO DELAYED IMPLANT
may jeopardize implant placement, such as
PLACEMENT: A SYSTEMATIC REVIEW AND META-­
o Sites presenting a thin and/or substantially damaged buccal
ANALYSIS
bone plate.
o Posterior sites exhibiting limited ridge height post-extraction,
3.1 | Preamble
which may lead to implant proximity to the maxillary sinus or
nerve structures. The main goal and the primary outcome of this systematic review
• In situations requiring that implant placement is significantly delayed were to compare immediate implant placement for single tooth re-
after tooth extraction, such as, due to the young age of the patient. placement to delayed implant placement in terms of implant survival
(Cosyn et al., 2019).
Secondary outcomes included the following:
2.4.2 | Which ARP treatment modality is most
effective?
• Need for additional bone augmentation at the buccal aspect of
The application of a bone grafting material to fill the extraction socket the implant
is strongly recommended when ARP is indicated. Clinicians should also • Wound-healing complications
consider sealing the socket orifice using an autogenous or exogenous • Marginal bone loss
barrier material with the purpose of protecting the underlying bone • Probing depth and bleeding on probing
188 | TONETTI et al.

• Papillary recession
3.3.3 | How do immediate and delayed implant
• Pink aesthetic score
placement compare in terms of marginal bone loss?
• Patient-reported outcome measures
• Long-term complications. Considering the baseline after loading (definitive crown installation),
there are only two RCTs (110 patients with 111 immediate implants and
The present systematic review includes eight investigations, compris- 106 patients with 110 delayed implants) measuring marginal bone loss.
ing three RCTs and five CCTs. The study material included 512 patients In both RCTs, bone augmentation was performed. In one RCT,
(517 implants) with a follow-­up ranging from 12 to 96 months. immediate implants were placed in case of dehiscence up to 50% of
Sufficient data were available to perform meta-­analyses of the the buccal bone wall resulting in 1.2 mm higher marginal bone loss
primary outcome and a limited number of secondary outcomes. for immediate implant placement. However, in the other RCT where
an intact buccal bone wall was an inclusion criterion, no significant
difference in marginal bone loss was observed.
3.2 | External validity of the findings
(Evidence Level 2: One multicenter RCT and one RCT)—(Strength
The statements in this consensus report are primarily applicable to of the statement: low due to heterogeneity).
adults who require extraction of one single-­rooted tooth with sub-
stantial socket wall integrity at the time of extraction in tooth-­bound
3.3.4 | How do immediate and delayed implant
areas. The majority of the studies inclusion and exclusion criteria
placement compare in terms of probing depth?
limited cases to sites without acute infection and with possibility to
achieve primary stability of the immediately placed implant in the Probing pocket depths were reported in one multicenter RCT. Probing
correct, prosthetically driven, position. pocket depths were greater at immediate implant compared with de-
layed placement (mean difference 0.8 mm. 95% CI: 0.4–1.2 mm) in this
particular multicenter RCT with non-­intact buccal bone wall.
3.3 | Consensus statements
(Evidence Level 2: One multicenter RCT, 124 patients)—(Strength
of the statement: low due to single multicenter RCT).
3.3.1 | What clinical conditions have been included
in studies comparing immediate and delayed implant
placement? 3.3.5 | How do immediate and delayed implant
placement compare in terms of pink aesthetic
Studies comparing immediate and delayed implant placement
score?
have used different inclusion and exclusion criteria, and these are
important for understanding heterogeneity of results. A critical One multicenter RCT showed a trend towards lower pink aesthetic
component is whether the buccal bone plate was essentially in- scores for immediate implant placement in cases with non-­intact
tact or not. Diverging results were observed in one multicenter buccal bone wall.
RCT that included extraction sockets with up to 50% loss of the (Evidence Level 2: One multicenter RCT and 124 patients)—
buccal bone plate and the other RCT that included essentially in- (Strength of the statement: low due to single multicenter RCT).
tact sockets. These observations may indicate that the level of
buccal bone loss is a major prognostic factor for immediate im-
3.4 | Clinical recommendations
plant placement.
(Evidence Level 4: Two RCTs designed for different purpose and
3.4.1 | Can immediate implant placement be
showing heterogeneous results). (Strength of the statement: low due
recommended for single tooth replacement?
to limited and indirect evidence and heterogeneity).
Clinicians considering immediate implant placement should be aware
that it carries an additional risk of early implant loss (4% excess implant
3.3.2 | How do immediate and delayed implant
loss). Furthermore, at sites with non-­intact alveolar sockets, inferior
placement compare in terms of implant loss?
clinical, radiographic and patient-­reported outcomes have been ob-
Immediate implant placement results in greater early implant loss served. No high-­level comparative data are available for intact sockets.
compared with delayed implant placement (survival rate of 94.9% vs
98.9%; RR 0.96, 95% CI [0.93; 0.99], p = 0.02).
3.4.2 | When should immediate implant placement
(Evidence Level 1: systematic review with meta-­analysis compris-
be avoided?
ing three RCTs—135 subjects with 136 immediate implants and 131
subjects with 135 delayed implants—and five CCTs—120 subjects Immediate implant placement should be avoided at
with 120 immediate implants and 126 subjects with 126 delayed im-
plants)—(Strength of the statement: moderate due to heterogeneity • Extraction sites with severely damaged sockets (more than 50%
and risk of bias). loss of one or more walls).
TONETTI et al. | 189

• Extraction sites in which achievement of primary stability requires While both types of early implant placement seemed to perform
positioning of the implant in a prosthetically incorrect position. well in these studies, significant issues in terms of study design and
• Extraction sites in which achievement of primary stability re- reporting, the pilot/proof of principle sample sizes and the absence of
quires selecting an improper implant diameter. valid comparisons with other implant placement timing and approaches
limit both the internal validity and the external validity of the results.

3.4.3 | Should grafting be considered an integral


component of immediate implant placement? 4.2 | External validity of the findings
Grafting at immediate implant placement is an integral component of The small number of documented and highly selected patients (140 sub-
the procedure in the majority of cases. jects treated by five experienced surgeons) and the concerns with the
design of the only RCT severely limit the generalizability of the results.

3.4.4 | Which are the clinical indications of


immediate implant placement? 4.3 | Consensus statements
Immediate implant placement may bring tangible patient benefits
4.3.1 | How do early and delayed implant placement
related to shorter treatment time and cost-­efficiency. At this stage,
compare in terms of implant loss?
indications should be limited to sites and patients that are perceived
to be at low risk: non-­aesthetic areas, intact alveoli, thick and flat There are no valid comparative data that have tested early and de-
periodontal phenotype. layed implant placement. Reported clinical performance shows high
levels of implant survival in small studies with up to 10 years follow-­up.
(Evidence Level 4: One RCT at high risk of bias and probably
3.5 | Recommendations for future research
invalid, one CCT and four retrospective or prospective case series,
There is a need for additional high-­quality RCTs comparing immediate 140 subjects with 140 implants)—(Strength of the statement: low
implant placement to delayed implant placement with CBCT analyses due to small sample, heterogeneity and risk of bias).
at different time points. Data should report on midfacial recession
with the situation prior to tooth extraction as baseline. In these stud-
4.3.2 | How do immediate and early implant
ies, the need for hard and soft tissue grafting should also be evaluated.
placement compare in terms of implant loss?
There is a need for PROMs, as these have been underreported in
research so far. These should include morbidity and patient preference. There are no valid comparative data that have tested immediate and
There is a need for cost and efficiency analyses on both protocols. early implant placement. Reported clinical performance shows high
levels of implant survival for both approaches.
(Evidence Level 5: expert opinion)—(Strength of the statement:
4 | E FFEC TI V E N E S S A N D PE R FO R M A N C E
low due to expert opinion in the absence of direct evidence).
O F E A R LY I M PL A NT PL AC E M E NT FO R
S I N G LE TO OTH S ITE S O F A NTE R I O R
A R E A S : A S YS TE M ATI C R E V I E W 4.3.3 | What clinical conditions have been included
in studies reporting on the performance of early
4.1 | Preamble implant placement?
Early implant placement has been advocated to address several Causes of tooth extraction/loss were generally not reported, and
shortcomings of conventional and immediate timing of insertion. neither were the conditions of the residual bony walls of the alveo-
These include (a) minimizing the potential negative effects of wound lus. The assumption that the main indication for early implant place-
contamination from residual infection due to the cause of tooth ment is extraction at sites with compromised alveoli needs to be
loss; (b) limiting the potential negative effects resulting from hard substantiated with additional research.
and soft tissue healing after tooth extraction; and (c) decreasing (Evidence Level 5: expert opinion)—(Strength of the statement:
treatment time with the potential to improve patient satisfaction low due to expert opinion in the absence of direct evidence).
(Graziani et al., 2019).
The systematic review identified data from six studies from five
4.3.4 | What is the performance of early
research groups reporting on a total of 140 implants in 140 subjects
implant placement in terms of peri-­implant health
(107 for type II and 33 for type III). Paucity of data, lack of compara-
parameters and aesthetics?
tive studies of high-­quality and study heterogeneity prevented exe-
cuting of meta-­analyses. The group expresses major concerns on the Few case series reporting on a limited number of patients have de-
scientific methodology and publication strategies observed in some scribed good and stable outcomes with type 2 and type 3 place-
of the included manuscripts. ments. Their strength is the long-­term follow-­up. It is, however,
190 | TONETTI et al.

unclear how these results compare with those obtainable with other The mean defect height resolution at re-­entry (in mm and/or %)
types of placement and what is their external applicability. was considered as the primary outcome. Moreover, the influence of
(Evidence Level 4: case series at different risk of bias)—(Strength the type of membrane, the absence of treatment, the addition of a
of statement: low due to the absence of RCTs and limited number of grafting material and the addition of a membrane on defect height
documented cases). resolution were evaluated.
Secondary outcomes included the following:

4.4 | Clinical recommendations


• Necessity for re-grafting
• Membrane exposure
4.4.1 | Is there evidence to recommend type 2 or
• Implant survival
type 3 implant placement in the anterior region?
• Clinical, radiographic and volumetric outcomes of follow-up
Clinicians should be aware that the evidence on type 2 and type 3 implant studies.
placement is based on a restricted number of experienced clinicians (five
surgeons) who have treated and followed a limited number of patients The systematic review includes 28 publications designed as RCTs
(N = 140 implants/patients followed for at least 1 year, see also Gallucci (n = 16), CCTs (n = 4) or follow-­up studies with an RCT design (n = 7)
et al., 2018). The limited available evidence shows good performance in or a CCT design (n = 1). The 20 short-­term studies reported on 819
the hands of few experienced clinicians and highly selected patients. It is, patients (1,070 implants) with a follow-­up range of 4–18 months.
however, unclear if such data can be generalized and how they compare The eight follow-­up studies reported on 174 patients (242 implants)
with those following immediate or delayed implant placement. with an observation period that had a range: 36–150 months. In all
included studies, titanium dental implants with either a smooth or
a moderately rough surfaced were used. Defect configurations and
4.5 | Recommendations for future research
dimensions present at implant sites vary intra-­ and inter-­individually.
Randomized clinical trials comparing different types of implant in- The selected literature did not provide sufficient information to de-
sertion are strongly advocated. termine these specific confounding factors related to the efficacy of
These trials should be designed taking into account not only the the procedure.
survival rate but also a broad array of clinically relevant outcomes Meta-­analyses were performed for the primary outcome (de-
ranging from aesthetic outcomes, dimensional hard and soft tissue fect height resolution) and whenever possible for secondary
changes, and patient-­reported outcomes. outcomes.
Trials should be carefully designed to evaluate the impact of sig-
nificant confounders such as causes of tooth extraction/loss, the
5.2 | External validity of the findings
conditions of the alveolus, concomitant bone regenerative proce-
dures and type of restorations. The high number of included and, in general, well-­designed RCTs
with a large number of treated patients supports the use of guided
bone regenerative procedures to reconstruct bone at dehiscence-­
5 | E FFI C AC Y O F L ATE R A L B O N E
type defects following implant placement. Generalizability is to
AU G M E NTATI O N PE R FO R M E D
some extent limited by a large heterogeneity in terms of materials
S I M U LTA N EO U S LY W ITH D E NTA L I M PL A NT
used and the fact that no superiority of any material (combination)
PL AC E M E NT: A S YS TE M ATI C R E V I E W A N D
could be shown. Clinicians should therefore be careful when choos-
M E TA-­A N A LYS I S
ing a specific bone substitute and barrier membrane combination
and check for documentation. It is also important to underline that
5.1 | Preamble
this procedure has been generally documented for buccal dehis-
The concept of placing dental implants in a prosthetically driven cences up to 8 mm in height.
position often results in ridge deficiencies and the need for an ad-
ditional bone augmentation procedure simultaneously with dental
5.3 | Consensus statements
implant placement. Guided bone regeneration applying various
biomaterials and barrier membranes is indicated in such clinical
5.3.1 | What is the percentage of defect height
situations. Clinically, it is difficult to decide on a specific interven-
resolution after bone augmentation procedures to
tion given the vast variety of biomaterials and membranes avail-
cover exposed implant threads?
able (Thoma, Bienz, Figuero, Jung, & Sanz-­Martin, 2019).
Therefore, the present systematic review analysed the scientific Defect height resolution at re-­entry ranged from 56.4% to 97.1% at
evidence regarding the efficacy of lateral bone augmentation proce- 4–6 months.
dures in terms of defect resolution in cases of horizontal ridge defi- (Evidence Level 2: systematic review without meta-­analysis of 20
ciencies after implant placement. publications [16 RCT's and four CCTs], of which nine had high, five
TONETTI et al. | 191

low and six unclear risk of bias reporting on 819 subjects with 1,070 statement: moderate since three studies were considered as low and
implants)—(Strength of statement: moderate due to risk of bias). one as unclear risk of bias. The remaining two studies were consid-
ered to have a high risk of bias).

5.3.2 | Is there a benefit to perform a bone


5.3.7 | What is the most common complication?
augmentation procedure to cover exposed implant
threads following implant placement? The most common complication is unintentional membrane expo-
sure with a mean rate of 22.7% (range: 16.8%–39.4%).
One RCT demonstrated a significantly more favourable defect
(Evidence Level 2: systematic review without meta-­analysis of 16
height resolution for sites with GBR compared to no treatment.
RCT's, four CCTs, 820 subjects and 1069 implants)—(Strength of the
(Evidence Level 3: One RCT, 22 subjects and 28 implants with an
statement: moderate).
unclear risk of bias)—(Strength of statement: low due to small evidence
Meta-­analyses did not demonstrate any significant differences
base).
between different biomaterials and barrier membranes as well as
their respective combinations.
5.3.3 | What is the most effective intervention to (Evidence Level 2: systematic review without meta-­analysis
obtain defect resolution? including 12 RCT's, one CCT, 502 subjects and 768 implants)—
(Strength of the statement: moderate since five studies were con-
All barrier membranes and bone substitute material combinations
sidered as low and four as unclear risk of bias. The remaining four
tested obtained varying degrees of defect resolution.
studies were considered to have a high risk of bias).
(Evidence Level 1: systematic review with meta-­analysis includ-
ing 11 RCTs, 366 subjects and 464 implants)—(Strength of the state-
5.3.8 | What are the mid-­and long-­term
ment: moderate, five RCTs were considered as low, three at unclear
outcomes of implants following bone augmentation at
and three at high risk of bias).
dehiscence and fenestration type defects?
The implant survival rate was not affected by the type of treat-
5.3.4 | Is there a benefit of covering a biomaterial
ment (membrane, biomaterial, sites with exposed implant threads)
with a barrier membrane?
and amounted to 95.0% (298 implants; 142 patients) with a fol-
Bone augmentation was significantly more favourable when a bio- low-­u p range between 36 and 96 months. The range of biologi-
material was covered with a membrane compared to a biomaterial cal complications was 0%–75% and the rate of peri-­implantitis
alone. 12.8%.
(Evidence Level 1: systematic review with a meta-­analysis, in- (Evidence Level 2: systematic review without meta-­analyses,
cluding two RCTs, 48 subjects and 52 implants)—(Strength of the including seven RCTs, one CCT, 142 subjects and 298 implants)—
statement: moderate due to unclear risk of bias). (Strength of the statement: moderate since one study was consid-
ered as low and four as unclear risk of bias. The remaining three
studies were considered to have a high risk of bias.)
5.3.5 | Is there a benefit supporting a barrier
membrane with a biomaterial?
5.4 | Clinical recommendations
Defect height reduction was significantly more favourable when a bio-
material supported a membrane compared to a membrane alone.
5.4.1 | Is there a need to perform a bone
(Evidence Level 4: One CCT, 19 subjects and 30 implants)—
augmentation procedure to cover exposed implant
(Strength of the statement: low (single CCT at high risk of
threads following implant placement?
bias)).
The clinician should consider the use of a bone augmentation
procedure to cover exposed implant threads after implant place-
5.3.6 | How frequently bone augmentation
ment. Such a procedure renders a favourable defect height
procedures yield to a 100% defect resolution and
resolution.
what is the necessity to re-­augment?
The percentage of sites with a 100% defect resolution was reported
5.4.2 | When should a clinician apply a bone
in one CCT only and amounted to 76.7%.
augmentation procedure to cover exposed implant
The necessity to re-­augment was inconsistently reported. No
threads following implant placement?
implant site needed re-­augmentation in three RCTs, whereas in two
studies, patients in need of re-­augmentation were excluded. The clinician should consider a bone augmentation procedure to
(Evidence Level 2: systematic review without meta-­analysis, five cover exposed implant threads at different peri-­implant defect con-
RCTs, one CCT, 165 subjects and 199 implants)—(Strength of the figurations (documented up to a defect height of 8 mm).
192 | TONETTI et al.

A staged bone augmentation procedure might be considered if 6 | OV E R A LL CO N S E N S U S A N D


the implant cannot be placed in a prosthetically driven position, no R ECO M M E N DATI O N S
primary stability can be obtained or in the presence of an unfavour-
able defect configuration. 6.1 | Clinical recommendations

6.1.1 | What is the best approach for transitioning


5.4.3 | Which intervention is recommended to treat
from a failing tooth to a successful implant-­supported
peri-­implant bone defects?
tooth replacement prosthesis?
All barrier membranes and bone substitute material combinations
Based on strong pre-­clinical evidence (Haugen, Lyngstadaas, Rossi,
tested obtained varying degrees of defect resolution (refer to SR).
& Perale, 2019; Donos, Dereka, & Calciolari, 2019; Omar, Elgali,
The clinician should combine a barrier membrane with a biomate-
Dahlin, & Thomsen, 2019), five different approaches that have
rial. Only few membranes and biomaterials are well documented, and
been documented to a different degree in clinical studies are il-
clinicians should be aware of the documentation before making a
lustrated in Figure 1. The evidence pertains mostly to single tooth
choice.
replacement, and thus, extrapolation to other scenarios may not
apply. Paucity of valid comparative studies does not allow for the
5.4.4 | What complications should clinicians be construction of an evidence-­based decision-­making algorithm to
aware of following bone augmentation procedures at select a specific approach that can be considered superior in indi-
peri-­implant defects? vidual clinical scenarios.
In the absence of solid evidence, clinicians have historically fol-
Clinicians should be aware of membrane exposure as the most com-
lowed an empiric approach that has been supported by indirect pre-­
mon complication. The occurrence of such an adverse event results
clinical and clinical evidence, mostly case series, to validate specific
in a less favourable defect height resolution.
protocols. This process involves the consideration of several critical
factors, such as the presence of local acute infection (purulence), the
5.5 | Recommendations for future research local anatomy in function of prosthetic needs, and the thickness and
integrity of the remaining alveolar bone and the soft tissues (bone
Further investigations should consider the following:
and soft tissue phenotype). Accumulated evidence from a growing
number of randomized clinical trials has contributed to sharpen the
• The impact of bone augmentation at dehiscence or fenestration
assessment.
defects around dental implants on long-term peri-implant health
The following general consideratons/recommendations can help
• Evaluating the need for bone augmentation at dehiscence or fen-
in assisting the decision-­making process:
estration defects around dental implants
• Evaluating the threshold and the influence of defect dimen-
• The presence of an acute local infection may render unpredict-
sions and configurations on clinical, biological and radiographic
able outcomes following immediate implant placement or alve-
outcomes
olar ridge preservation/ridge augmentation (ARP/RA). In such
• Reporting on the success of the treatment (100% defect resolu-
situations, early, delayed or late implant placement should be
tion) and on the impact of incomplete bone augmentation (e.g.
considered.
<100% defect resolution and complications) on the efficacy of the
• The absence of primary stability upon implant placement and/or
intervention and on clinical, biological and radiographic outcomes
inability to place the implant in a favourable, restoratively driven
• Reporting on the effect of bone augmentation procedures on the
position speaks against the indication of implant placement. In
hard and soft tissue contour, on the level of the mucosal margin
such situations, ARP/RA and delayed or late implant placement
and on aesthetic outcomes
with simultaneous or staged alveolar ridge augmentation (implant
• Including study patients in mid- to long-term follow-up examina-
site development) should be considered.
tions with standardized ways of reporting clinical, biological and
• A damaged alveolus, particularly in the presence of large buc-
radiographic outcomes as well as PROMs.
cal dehiscence or coronal fenestration, should be recognized as
a clinical scenario in which the indication of immediate implant
In general, for the planning of future studies related to bone augmen-
placement may be associated with a higher risk of achieving un-
tation procedures, it is recommended to report on specific inclusion
favourable therapeutic outcomes. In such situations, clinicians
criteria (e.g. ridge dimensions and configuration prior to implant place-
should consider an early implant placement protocol or ridge re-
ment; three-­dimensional defect configuration after implant placement;
construction at the time of tooth extraction and delayed or late
and extent of bone augmentation), surgical protocols (e.g. bone-­ or
implant placement.
prosthetically driven implant placement), early (e.g. wound dehis-
• The presence of an intact alveolus and a thick periodontal phe-
cences and barrier membrane exposures) and late (e.g. mucositis and
notype represents a favourable scenario to indicate immediate
peri-­implantitis) complications.
TONETTI et al. | 193

implant placement, particularly so in subjects with low aesthetic implant-­retained prosthesis. While it is recognized that research
demands and/or in non-aesthetic areas. on multiple extraction sites poses additional methodological and
• The presence of a thin periodontal phenotype and/or a high smile analytical challenges, it is important to expand the evidence base
line in subjects with high aesthetic demands represents an unfa- in this direction.
vourable scenario for the indication of immediate or early implant The population requiring tooth replacement is ageing and
placement. In such situations, ARP-SG and delayed or late implant typically presents with a considerable set of relevant medical co-­
placement should be considered. Consideration of the need and morbidities and the long-­term consumption of multiple medications.
role of soft tissue augmentation in such cases was beyond the Ethically appropriate research on tooth replacement in special needs
scope of this specific consensus. groups is urgently needed, as well.
• In subjects presenting uncontrolled local and/or systemic condi-
tions that may alter the healing dynamics of extraction sockets
C O N FL I C T O F I N T E R E S T
(e.g. smoking, diabetes mellitus and severe autoimmune diseases),
the indication of delayed or late implant placement should be Workshop participants filed detailed disclosure of potential conflict of
considered over immediate or early implant placement. Clinicians interest relevant to the workshop topics, and these are kept on file.
must be aware that the outcomes of ARP/RA procedures may be Declared potential dual commitments included having received re-
negatively affected by the presence of such systemic conditions search funding, consultant fees and speaker fee from Biomet Zimmer,
regardless of the timing of implant placement. BioHorizons, Colgate, Dentaid, Dentsply Implants, Dentium, Geass,
Geistlich Pharma AG, Klockner, MIS Implants, Osteogenics Biomedical,
Osteology Foundation, Procter & Gamble, Straumann, Sweden &
Martina, Sunstar SA and VITA Zahnfabrik.
6.2 | Recommendations for future research
The group felt that, while considerable progress has been made since
ORCID
the last time the Workshop addressed the quality of research in im-
plant dentistry (Tonetti & Palmer, 2012), several challenges persist. Maurizio S. Tonetti https://orcid.org/0000-0002-2743-0137
Future research shall focus on providing appropriate compara- Gustavo Avila-Ortiz https://orcid.org/0000-0002-5763-0201
tive data assessing the efficacy, cost-­effectiveness and patient ac-
Jan Cosyn https://orcid.org/0000-0001-5042-2875
ceptability of different approaches. Such studies shall be designed in
Filippo Graziani https://orcid.org/0000-0001-8780-7306
order to enable the development of evidence-­based decision-­making
algorithms and clinical recommendations. Emphasis on methodologi- Phoebus Madianos https://orcid.org/0000-0002-5990-5723
cal issues in design, execution and reporting is required to continue Ignacio Sanz-Martin https://orcid.org/0000-0001-7037-1163
to improve control of bias, external validity and integrity of research
Daniel Thoma https://orcid.org/0000-0002-1764-7447
findings.
Fabio Vignoletti https://orcid.org/0000-0002-4574-3671
In order to sustain decisive improvements in the evidence base,
the research community should focus on definition of a standard
outcome data set, on clinically meaningful outcomes and on clini-
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