The ITI Mission is ...

“... to promote and disseminate knowledge on all aspects of implant dentistry and related tissue regeneration through research, development and education to the benefit of the patient.”

Preface

Since the introduction of implant dentistry some 40 years ago, much has changed. The development of implant materials and implant design, the evolution of prosthetic materials and prosthetic design, and the optimization of surgical and prosthetic treatment protocols have opened this field of dentistry to a large group of treatment providers and patients. Oral implantology has provided edentulous patients with denture retention, immensely improving their quality of life. Based on research in the field and increased practical knowledge, a treatment involving two implants has now been described as the standard of care for retaining an overdenture in the edentulous patient.

Innovation, knowledge, and experience have led to improved implant designs and optimized treatment protocols. Research and treatment evaluations have shown us how to optimize the biomechanical design of the superstructures and taught us how to select patients for the different treatment protocols, making oral implantology an ever more predictable treatment option. Over the past 40 years, we have gone from 6 months of healing in the edentulous maxilla and 3 months in the edentulous mandible to immediate loading protocols for a large group of patients and many treatment indications.

Computer technology and CAD/CAM are playing a more dominant role in oral implantology. Guiding systems and computer-assisted superstructure manufacturing have given clinicians the tools required to develop an entire treatment plan in a virtual environment. This is the direction in which oral implantology is rapidly developing.

In August of 2008, the ITI met at the 4th ITI Consensus Conference in Stuttgart to discuss a large number of topics, including loading protocols for edentulous patients and computer technology and CAD/CAM for edentulous patients. The proceedings of this conference were published in a supplement to the International Journal of Oral and Maxillofacial Implants in 2009.

This Treatment Guide provides a summary of the findings and statements of the 4th Consensus Conference, completed with the underlying scientific evidence. Based on these statements, guidelines and recommendations are provided for the various treatment options for edentulous patients, illustrated with detailed case reports.

The authors hope that this fourth volume in the series of ITI Treatment Guides will provide clinicians with a sound resource to turn to when developing treatment plans for their edentulous patients.

Daniel Wismeijer

Daniel Buser

Urs C. Belser

Acknowledgment

We would like to thank Straumann AG, our corporate partner, for its continuing support, without which the realization of the ITI Treatment Guide series would not have been possible. The ITI and the authors are solely responsible for its scientific content.

Editors and Authors

Editors:

Daniel Wismeijer, DMD, Professor
Department of Oral Function and Restorative
Dentistry
Section of Oral Implantology and Prosthetic Dentistry
Academic Center for Dentistry Amsterdam (ACTA)
Louwesweg 1
1066 EA Amsterdam, Netherlands
E-mail: d.wismeijer@acta.nl

Daniel Buser, DDS, Dr. med. dent.
Professor and Chairman
Department of Oral Surgery and Stomatology
School of Dental Medicine
University of Bern Freiburgstrasse 7
3010 Bern, Switzerland
E-mail: daniel.buser@zmk.unibe.ch

Urs C. Belser, DMD, Professor
Division of Fixed Prosthodontics and Occlusion
School of Dental Medicine
University of Geneva
19, rue Barthélemy-Menn
1205 Geneve, Switzerland
E-mail: urs.belser@unige.ch

Authors:

Daniel Wismeijer, DMD, Professor
Department of Oral Function and Restorative
Dentistry
Section of Oral Implantology and Prosthetic Dentistry
Academic Center for Dentistry Amsterdam (ACTA)
Louwesweg 1
1066 EA Amsterdam, Netherlands
E-mail: d.wismeijer@acta.nl

Paolo Casentini, Dr.
Narcodont
Piazza S. Ambrogio 16
20123 Milano, Italy
E-mail: paolocasentini@fastwebnet.it

German 0. Gallucci, Dr. med. dent., DMD
Director of Oral Implantology
Harvard School of Dental Medicine
188 Longwood Avenue
Boston, MA 02115, USA
E-mail: german_gallucci@hsdm.harvard.edu

Matteo Chiapasco, MD, Professor
Head Unit of Oral Surgery
School of Dentistry and Stomatology
Department of Head and Neck
San Paolo Hospital, University of Milan
Via Beldiletto 1/3
20142 Milano, Italy
E-mail: matteo.chiapasco@unimi.it

Contributors

Marina Stella Bello-Silva, DDS, PhD Student
LELO - Special Laboratory of Lasers in Dentistry
School of Dentistry of the University of São Paulo
Av. Prof. Lineu Prestes, 2227
São Paulo, SP 05508-000, Brazil
E-mail: marinabello@usp.br

Arne F. Boeckler, DMD, Dr. med. dent.
Associate Professor
Martin Luther University Halle-Wittenberg
Department of Prosthodontics
Groϐe Steinstraβe 19
06108 Halle (Saale), Germany
E-mail: arne.boeckler@medizin.uni-halle.de

Luiz Otávio Alves Camargo, DDS, MSc, PhD
Av. Brig. Faria Lima, 1478 Cj. 2205/2208
Sao Paulo, SP 01451-001, Brazil
E-mail: luizotavio@me.com

Paolo Casentini, Dr.
Narcodont
Piazza S. Ambrogio 16
20123 Milano, Italy
E-mail: paolocasentini@fastwebnet.it

Matteo Chiapasco, MD, Professor
Head Unit of Oral Surgery
School of Dentistry and Stomatology
Department of Head and Neck
San Paolo Hospital, University of Milano
Via Beldiletto 1/3
20142 Milano, Italy
E-mail: matteo.chiapasco@unimi.it

Luca Cordaro MD, DDS, PhD
Head Department of Periodontics and Prosthodontics
Eastman Dental Hospital Roma and Studio Cordaro
Via Guido d’Arezzo 2
00198 Roma, Italy
E-mail: lucacordaro@usa.net

German O. Gallucci, Dr. med. dent., DMD
Director of Oral Implantology
Harvard School of Dental Medicine
188 Longwood Avenue
Boston, MA 02115, USA
E-mail: german_gallucci@hsdm.harvard.edu

Henny J.A. Meijer, Prof. Dr.
Department Oral and Maxillofacial Surgery
University Medical Center Groningen
P.O. Box 30.001, 9700 RB Groningen, Netherlands
E-mail: h.j.a.meijer@kchir.umcg.nl

Dean Morton, BDS, MS
Professor and Interim Chair Department of Oral Health and Rehabilitation
University of Louisville School of Dentistry
501 S. Preston, Louisville, KY 40202, USA
E-mail: dean.morton@louisville.edu

Alan G.T Payne, BDS, MDent, DDSc, FCD (SA)
Oral Implantology Research Group
Sir John Walsh Research Institute
University of Otago
310 Great King Street
Dunedin, 9016, New Zealand
E-mail: alan.payne@stonebow.otago.ac.nz

Geert Stoker, Dr.
Practice for Oral Implantology and Prosthodontics
Amazonestraat 2
3207 NB Spijkenisse, Netherlands
E-mail: geertstoker@wxs.nl

Ali Tahmaseb, Dr.
Department of Oral Function and Restorative
Dentistry, Section of Oral Implantology
and Prosthetic Dentistry
Academic Center for Dentistry Amsterdam (ACTA)
Louwesweg 1, 1066 EA Amsterdam, Netherlands
E-mail: ali@tahmaseb.eu

Pedro Tortamano, DDS, MSc, PhD
Rua Jeronimo da Veiga, 428 cj. 51
Itaim Bibi, SP 04536-001, Brazil
E-mail: tortamano@usp.br

Hans-Peter Weber, DMD, Dr. med.dent.
Raymond J. and Elva Pomfret Nagle Professor and Chair
Department of Restorative Dentistry
and Biomaterials Sciences
Harvard School of Dental Medicine
188 Longwood Avenue
Boston, MA 02115, USA
E-mail: hpweber@hsdm.harvard.edu

1   Introduction

D. Wismeijer

The mission of the ITI is to promote and disseminate knowledge about all aspects of implant dentistry and related tissue regeneration through research, development, and education. During the first decade of the 21st century, the leading role of the ITI in informing the dental community as well as its patients was highlighted by various relevant endeavors coordinated by the ITI Education Committee:

• The ITI Consensus Conferences periodically update the body of evidence on which many clinical approaches in implant surgery and implant prosthodontics are based. These conferences lead the way for clinicians in the field to provide their patients with evidence-based care.

• The ITI Treatments Guides provide clinicians with objective recommendations for implant treatment. These recommendations and treatment concepts based on the outcomes and recommendations of the ITI Consensus Conferences and are supported and illustrated by experienced clinicians.

• The Glossary of Oral and Maxillofacial Implants is another tool for professionals in the field of implant dentistry. With its more than 2000 terms in various areas, it is the standard work in the field.

• The SAC Classification in Implant Dentistry (2009) is a reference tool for practitioners when selecting treatment approaches for individual patients. It allows them to assess the degree of complexity, the risks involved when treating the individual patient, and the skills required to provide the necessary treatment. This publication is based on an ITI conference on this subject held in March 2007.

The 4th ITI Consensus Conference was held in August of 2008, discussing various topics in implant dentistry, including loading protocols and applications of computer technology. The proceedings of this conference were published in a supplement to the International Journal of Oral and Maxillofacial Implants (JOMI) in 2009.

This Treatment Guide, the fourth in the series, focuses on the treatment of the edentulous patient. Based on the body of literature that was studied for the 4th ITI Consensus Conference and the ensuing recommendations and results, an evidence-based approach is presented and supported by detailed case reports. We hope that this fourth Treatment Guide—like the previous three—will once again be a useful tool for clinicians in achieving their treatment goals.

2   Proceedings of the 4th ITI Consensus Conference: Loading Protocols in Implant Dentistry

G.O. Gallucci, D. Morton, H.R Weber, D. Wismeijer

Group 3 of the 4th ITI Consensus Conference held in Stuttgart reviewed the current scientific evidence for loading protocols in implant dentistry. The group was composed of three teams:

• Partially edentulous patients, anterior region

• Partially edentulous patients, posterior region

• Edentulous patients

The participants were:

Group leader:     Hans-Peter Weber

Reviewers:          German 0. Gallucci
                                Linda Grütter
                                Mario Roccuzzo

Secretary:           Dean Morton

Co-Reviewers:    Urs Belser
                                Luca Cordaro

Participants:       Gil Alcoforado
                                Juan Blanco
                                Roberto Cornellini
                                Tony Dawson
                                Andreas Feloutzis
                                Siegfried M. Heckmann
                                Frank L. Higginbottom
                                Haldun Iplikçioğlu
                                Bob Jaffin
                                Hong-chang Lai
                                Niklaus P. Lang
                                Richard Leesungbok
                                Robert A. Levine
                                Torsten E. Reichert
                                George K. B. Sándor
                                Makoto Shiota
                                Alejandro Trevino Santos

The group addressing edentulous patients was to present well-structured scientific and clinical evidence related to maxillary and mandibular implant-supported rehabilitations. The specific aim was to assess the survival outcome of various loading protocols according to treatment sequence and selected prosthodontic design.

The electronic search yielded 2,371 publications, of which 61 articles met the inclusion criteria. Only studies reporting on implants with “rough surfaces” were selected for this review. The reported data covered 2,278 patients and 9,701 implants. Studies were grouped according to treatment protocols and prosthodontic designs, and results on conventional, early, and immediate loading were assessed separately for fixed and removable dental prostheses (Table 1).

Although several randomized controlled trials (RCT) and reviews have demonstrated clinical efficiency in shortening the time to loading for edentulous patients, the related scientific evidence is mostly presented from the perspective of implant survival or success, with only limited information about the prosthodontic treatment outcome. To assess the impact of modified loading protocols in edentulous patients accurately, data was analyzed separately for: (1) maxillary and mandibular protocols; (2) fixed and removable rehabilitations; (3) rough-surfaced implants; and (4) implant placement into healed sites or extraction sockets not yet healed. These factors have often been presented as having a direct influence on the implant and prosthodontic survival rate.

RCTs: randomized controlled trials, pats: patients, imps: implants, OH: outcome homogeneity, + (less than 10% variation), - (more than 10% variation)

2.1 Recommended Clinical Procedures Regarding Loading Protocols for Endosseous Implants in Edentulous Patients

Several factors have been identified as playing a key role in successfully achieving osseointegration with modified loading protocols: initial implant stability, implant surface characteristics, anatomical conditions, bone metabolism, interim prosthesis design, and occlusion pattern during the healing phase. Ideally, they should be considered in the selection of an appropriate loading protocol for the edentulous patient (see Chapter 5).

According to the 4th ITI Consensus Conference, clinical recommendations for implant loading protocols in different indications were presented using a novel validation protocol (JOMI Supplement, 2009). This validation was based on parameters presented in Table 1. In order to propose clinical recommendations for various loading protocols, study design, sample size, and outcome homogeneity (OH) were considered the fundamental parameters. Outcome homogeneity was considered positive (OH+) when the variation of implant survival rates for the treatment protocol was 10% or less, and negative (OH-) when the variation was greater than 10% (Table 1).

Using these criteria, scientific and/or clinical validation was categorized according to the following four groups:

• SCV: scientifically and clinically validated

• CWD: clinically well documented

• CD: clinically documented

• CID: clinically insufficiently documented

The highest level of scientific and clinical validation was found for conventional loading with mandibular overdentures and maxillary fixed dental prostheses. Insufficient scientific or clinical documentation/validation was found for immediate loading of maxillary overdentures as well as for immediate loading of immediately placed implants combined with fixed or removable dental prostheses in either jaw. All other loading protocols for edentulous arches showed different degrees of clinical documentation without proper scientific validation (Table 2).

SCV: scientifically and clinically validated - dark green; CWD: clinically well-documented - light green; CD: clinically documented -yellow; CID: clinically insufficiently documented - red

Table 2 represents a simplified method for selecting a loading protocol based on the scientific evidence available for each clinical situation. The dark and light green loading protocols have been at least clinically well documented with proven homogenous outcomes in several publications. The yellow group indicates clinically documented loading protocols with a small number of publications or a limited sample size. In the red group, all the protocols presented an important variation on their outcome homogeneity when survival rates were assessed. These protocols can be considered to be technique-sensitive, where careful patient selection, operator skills, and risk benefit for the patient should be taken into consideration before selecting a red-group loading protocol.

This description, however, does not refer to the level of complexity for the procedures that, in some cases, are still considered advanced or complex according to the SAC classification.

2.1.1 Definition of Terms

The group revisited the conclusions and consensus statements from the previous ITI Consensus Conference as published by Cochran and coworkers, as well as the various definitions for loading protocols from other organizations. Table 3 summarizes those different proposed definitions of terms.

Loading protocols were considered as part of a Congress Consensus meeting in Barcelona, Spain, in 2002. The following definitions for implant loading were agreed on by Aparicio and coworkers:

• Immediate loading. The prosthesis is attached to the implants the same day the implants are placed.

• Early loading. The prosthesis is attached during a second procedure, earlier than the conventional healing period of 3 to 6 months. The time of loading should be stated in terms of days/weeks.

• Conventional loading. The prosthesis is attached to the implants during a second procedure 3 to 6 months after the implants are placed.

• Delayed loading. The prosthesis is attached during a second procedure, later than the conventional healing period of 3 to 6 months.

The 3rd ITI Consensus Conference in 2003 in Gstaad, Switzerland, modified the definitions as follows (Cochran and coworkers, 2004):

• Immediate loading. A restoration is placed in occlusion with the opposing dentition within 48 hours of implant placement.

• Early loading. A restoration is in contact with the opposing dentition and placed at least 48 hours after implant placement but no later than 3 months afterwards.

• Conventional loading. The prosthesis is attached during a second procedure after a healing period of 3 to 6 months.

• Delayed loading. The prosthesis is attached during a second procedure that takes place sometime later than the conventional healing period of 3 to 6 months.

• Immediate restoration. A restoration is inserted within 48 hours of implant placement but is not in occlusion with the opposing dentition.

For a Consensus Conference of the European Association for Osseointegration (EAO) in Zurich in 2006, Switzerland, a review was presented by Nkenke and Fenner. The group accepted the following definitions:

• Immediate loading. A situation where the superstructure is attached to the implants in occlusion with the opposing dentition within 72 hours.

• Conventional loading. A situation where the prosthesis is attached to the implants after an unloaded healing period of at least 3 months in the mandible and 6 months in the maxilla, respectively.

• Non-functional immediate loading and immediate restoration. Used when prostheses are fixed to the implants within 72 hours without achieving full occlusal contact with the opposing dentition.

Esposito and coworkers published an updated version of their systematic review regarding different times for loading dental implants, and based it on the following definitions:

• Immediate loading. This means placing implants in function within 1 week after placement. No distinction was made between occlusal and non-occlusal loading.

• Early loading. This means placing implants in function between 1 week and 2 months after placement.

• Conventional loading. This means placing implants in function after 2 months.

Based on these definitions and considering the Cochrane Report (Esposito and coworkers, 2007) and the 4th ITI Consensus Conference, group 3 on loading protocols for the edentulous patient recommends the following ITI definitions for dental implant loading:

• Conventional loading. Dental implants not connected to prostheses are allowed a healing period of more than 2 months after implant placement.

• Early loading. Dental implants are connected to the prostheses between 1 week and 2 months subsequent to implant placement.

• Immediate loading. Dental implants are connected to the prostheses within 1 week subsequent to implant placement.

In addition, the group recommended abandoning the separate definition for delayed loading, since it will be included under the definition of conventional loading.

2.2 Consensus Statements

Statement 1
For the edentulous mandible and maxilla, the existing literature supports the loading of microrough implants between 6 and 8 weeks after implant placement with fixed or removable prostheses in the mandible, and fixed prostheses in the maxilla. Therefore, for the majority of patients, loading of dental implants for these indications and within this timeframe should be considered routine.

Statement 2
A lower level of evidence exists to support loading of dental implants with maxillary overdentures for this timeframe (6 to 8 weeks). Similarly, scientific evidence supporting loading of dental implants in the edentulous arches between 2 and 6 weeks remains limited at this time.

Statement 3
In the case of the edentulous mandible, the literature supports immediate loading of microrough implants with fixed prostheses or overdentures. This consensus statement is made with the understanding that the treatment is complex. Treatment within this protocol, for the above indications, can be considered a valid treatment option for clinicians with the appropriate education, experience, and skills.

Statement 4
In the case of the edentulous maxilla, the literature supports immediate loading of microrough implants with fixed prostheses. This consensus statement is made with the understanding that the treatment is complex. Treatment within this protocol, for the above indications, can be considered a valid treatment option for clinicians with the appropriate education, experience, and skills.

Statement 5
For the edentulous maxilla, insufficient data exists to support immediate loading of dental implants with overdenture prostheses.

Statement 6