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J Am Dent Assoc, Vol 135, No 1, 92-97.
© 2004 American Dental Association
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ASSOCIATION REPORT

Dental endosseous implants

An update



ADA COUNCIL ON SCIENTIFIC AFFAIRS


   ABSTRACT
TOP
 ABSTRACT
FUTURE DIRECTIONS
 REFERENCES
 
Background. The ADA Council on Scientific Affairs has developed an updated report on endosseous implants to aid dental professionals in considering and incorporating practical applications of implantation therapy in general practice.

Overview. This report addresses the demonstrated high success rates of multiple implant designs in various clinical situations, the factors contributing to elevated risk of implant failure and implantation therapy as a comprehensive process of patient care. The Council also provides a list of products available to the profession that have received the ADA Seal of Acceptance.

Conclusions and Practice Implications. The Council recommends that practitioners use implantation therapies and systems judiciously in accordance with the current best evidence. The Council also urges evaluators to use common and consistent criteria for reporting the outcomes assessment in clinical studies of various implant treatments.

Since the ADA’s 1996 update on the clinical application of osseointegrated implants,1 their use has continued to increase in breadth and scope, with a wide range of new and innovative approaches reported in the research literature. The published literature on dental implants has grown to more than 5,000 publications, including journals that focus exclusively on dental implant treatment and research. The literature also has revealed rapidly emerging developments and innovations in such areas as immediate implant placement and loading, design innovations that allow implant abutments to be placed down inside the implant for enhanced and predictable mechanical stability, distraction osteogenesis and the use of implants for orthodontic anchorage.

Metallic dental implants are the first generation of tissue engineering devices that will affect the dental profession.

Since the introduction of cylindrical-style endosseous implants to the profession through the research efforts of Brånemark and colleagues2 and Schroeder and colleagues,3 there has been a dramatic movement away from their application as an experimental, even esoteric, treatment modality to one that can be considered a standard of care and be recommended routinely in general practice. In recent years, numerous clinical trials, outcomes research and consensus reports have concluded that implantation therapy for the treatment of the edentulous mandible should be recommended and applied to general practice.4–9 Furthermore, according to the 2002 McGill Consensus Statement on Overdentures, "Mandibular two-implant overdentures have been shown to be superior to conventional dentures in randomized and nonrandomized clinical trials that ranged in duration from six months to nine years."10

The placement of two implants in the anterior mandibular area provides a significant increase in the patient’s perceived quality of life (relative to conventional dentures)4 and masticatory function,11,12 and it may improve the patient’s dietary choices.13 In addition, this simple treatment has been shown to maintain bone mass and volume over a five-year period.14 For the partially edentulous patient, implantation therapy has focused on the importance of site development for implant placement (for example, through the use of various hard-or soft-tissue grafting). Autogenous grafting approaches (those using the patient’s own bone) still are popular, but there have been significant strides in the application of platelet-rich plasma and surgical distraction osteogenesis, as well as the U.S. Food and Drug Administration, or FDA, recent approval of a bone-inductive growth factor for bone grafting—bone morphogenetic protein 2.

Given the advances in the field of implant dentistry, developing current evaluation criteria that clinicians can use to assess treatment outcomes and survival rates is a complex task. In the past decade, significant developments in the concepts and principles of evidence-based care (for example, standards in clinical trial design) have provided the profession with the tools to assess this and other therapeutic interventions. To emphasize one point, evidence-based care means the judicious use of current best evidence, recognizing that no study is perfect in every respect or necessarily applicable to every patient. Implantation therapy is not only the design and application of an implantable device, but it also is a process of patient care. This process begins with diagnostic assessment of the patient and determination of the relative merits of the dentition, followed by an assessment of the costs and benefits of maintaining or perhaps removing and replacing the dentition with an alternative.

A challenge for the practitioner is to feel confident that the chosen medical device has a sufficient outcome assessment.

Based on the results of studies published since 1996, implant survival in various clinical situations has remained high. For example, in 14 clinical studies covering 10,006 implants placed in edentulous, partially edentulous or single-tooth cases at follow-up periods of two to 16 years, the tested systems had survival rates ranging from 76 to 98.7 percent, with a mean survival rate of 94.4 percent.15–28

For partially edentulous treatment alone, 10 clinical studies covering 2,724 implants reported an overall mean survival rate of 92.5 percent, with survival rates ranging from 81 to 97.2 percent.29–38 With regard to single-tooth implant treatment, 10 clinical trials that included 1,453 implants reported similarly high survival rates, ranging from 94.4 to 99 percent, with a mean survival rate of 96.7 percent.39–48 Furthermore, 13 clinical studies of implant overdenture treatment reported a mean survival rate of 87.1 percent,49–60 and 10 studies covering 3,344 various bone grafting/implant treatments reported a mean survival rate of 86.8 percent.61–69 Also, immediate loading does not appear to lower survival rates significantly, with three recent studies reporting survival rates ranging from 93.5 to 95.6 percent.70–72 As these findings suggest, the average survival rates of multiple implant designs placed in various clinical situations are more than 90 percent.

When balanced with the relative prognosis of alternative therapies (for example, endodontics, post and core, and crown), the judicious application of treatment modalities that include implants may provide a more predictable outcome. A challenge for the individual practitioner is to feel confident that the chosen medical device has a sufficient outcome assessment so that he or she ethically can use that device in patients.

To address this challenge, the ADA Seal of Acceptance program,73 the FDA74 and the European Union have established guidelines for safety and efficacy in the use and application of dental implants (BoxGo). When considering the use of implantation therapy for a patient, practitioners should use therapies and systems that use the current best evidence.75 Whenever possible, this evidence should involve controlled clinical trials, although well-performed case control designs can, in some situations, provide nearly equivalent supportive evidence. When evaluating a system for their offices, practitioners should look for ongoing documentation that is obtained from both highly controlled situations such as universities and practice locations similar to their own. Despite the significant lag time between innovation and evaluation, it is important to evaluate assessment criteria for dental implants, as these devices are intentionally placed in patients for a lifetime.


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  		BOX ADA-ACCEPTED DENTAL IMPLANT SYSTEMS.

 
Owing to consistent and rapid advances in innovation, research and clinical application, the field of implant dentistry has undergone many changes that can be confusing. To assist in the evaluation of dental implant systems, clinical evaluators should use common and consistent criteria for reporting the outcomes assessment of clinical studies, specifically with regard to implant treatment. Many scientific and clinical journals now follow a standardized format for presenting information, which authors must follow to facilitate the readers’ assessment of the product’s safety, efficacy and relevance to their practice.76 When reading these studies, practitioners should consider each of the following factors carefully: number of patients followed, number of implants, age range of study population, type of bone quality and quantity, arch in which implants were placed, length of implants, submerged ("two-stage") implants versus one-stage implants, time of loading after placement, type of prosthesis, opposing occlusion and occlusal scheme, radio-graphic assessment, implant mobility assessment, assessment of soft tissue health and length of follow-up.

Uniform criteria for reporting the survival and failure analysis of implant treatments should be the "gold standard," along with multicenter designs (in which many practitioners of different abilities are involved) and the performance of appropriate biostatistical analysis (for example, multivariate analysis).77 Equally important, a study should provide information on the patient’s esthetic outcomes and prosthetic complications.75 The importance of standardized reporting is underscored further by the current emphasis on evidence-based information and outcomes assessment of treatment protocols in the health sciences.

A uniform definition for implant success versus survival has been difficult to determine, owing to the unclear predictive measures of conventional periodontal measurement techniques (for example, periodontal probing of implants). Surrogate measures such as probing around implants only measure local inflammation, which may or may not relate to implant outcomes.78 In the near future, the application of diagnostic approaches derived from studies of molecular genomics (the study of the human genome) and proteomics (the study of proteins and protein interactions) will allow for more consistent and useful outcome measures. While criteria for implant success have been published,79,80 their focus often has been implant system–specific, which over the past few years has resulted in greater emphasis on implant survival. Again, innovations in diagnostic technologies, such as resonance frequency analysis, may play a useful role in assessing the longitudinal integration of an individual implant as a function of the loading environment.81–84

Based on the reported literature, the safety and efficacy of certain implantation therapies may not be applicable to all patients. In recent years, several defined patient populations have emerged that have an elevated risk of experiencing complications after implantation therapy. While still controversial, evidence suggests that smoking,85,86 physical debilitation (for example, advanced osteoporosis)87 and uncontrolled or poorly controlled diabetes88 are among the factors contributing to an elevated risk of implant failure. For these factors, the types of implants and the related surgical procedures have been shown to vary in terms of clinical outcome,89 as do the properties of the bone into which implants are placed.81 Patients with elevated risk factors (for example, smoking or diabetes) and patients who are immunosuppressed, including those taking continuous high-dose systemic corticosteroids, should be counseled during the informed consent process and be monitored closely if implantation therapy is pursued. Pre-and postoperative management of the care of patients also appears to influence the outcomes of care. For instance, the use of pre- and postsurgical systemic antibiotics90 or oral rinses with chlorhexidine gluconate91 appears to improve the clinical outcomes of implantation therapy.

Because implantation therapy has a high level of predictable success, what are the roles for this therapy in general practice? Given that a clinician can manage the care of a patient ethically by being a part of a specialist team—working with a prosthodontist and allied surgical specialists—implantation therapy should be considered an important part of managing the care of a patient with an edentulous mandible or a missing single tooth. In the case of an edentulous mandible, the ability to provide retention and stability to a conventional denture is significant with two implants in the interforaminal region assisted with a simple ball or stud-type attachment.

The literature demonstrates that mandibular overdenture therapy is a highly predictable therapy that results in prevention of bone loss; mechanical stability; and improved function, speech, nutrition and quality of life. Edentulous patients who have received overdenture therapy (versus a complete denture) are more likely to remain engaged in routine dental practice after initial therapy and return for maintenance (for example, replacing attachments, relines) to rehabilitate their oral function fully and thereby enhance their quality of life. Lifelong maintenance, management and ongoing care are modifying the profession’s treatment approach for edentulous patients and reinforcing the role of dentists as ongoing health care providers.

A second major group that can benefit from receiving implantation therapy in general practice is patients who have a single missing tooth or a failing endontically treated tooth. When treating a dental patient with an edentulous mandible, the clinician should diagnose and manage the care of the patient appropriately, which may include referring the patient to a prosthodontist, if necessary. It is important for the clinician to provide a comprehensive assessment of and information on realistic outcomes of each proposed treatment modality, with or without implantation therapy. This will allow the patient to make an informed decision. The ability to predictably replace a posterior tooth with sufficient bone volume (grafted or not grafted) using implants without the need for partial or full coverage restorations on the adjacent teeth provides the highest quality care for patients. The restoration of a missing anterior tooth entails additional esthetic issues that may be a challenge to the implantation team. In this situation, involving the patient as a part of the team is a key part of the informed consent process because managing the care of the patient often entails interfacing with other specialists such as orthodontists, periodontists, oral maxillofacial surgeons and prosthodontists.


   FUTURE DIRECTIONS
TOP
 ABSTRACT
 FUTURE DIRECTIONS
REFERENCES
 
We are living in an exciting time in dentistry. Traditional solutions for replacing missing teeth have been to cobble, wire or crown adjacent teeth with minimal regard to the risks or benefits of simply replacing the tooth itself. Metallic dental implants are the first generation of tissue engineering devices that will affect the dental profession. In the near future, genomic and proteomic applications could offer biosynthetic solutions for the replacement of missing teeth with benefits beyond those seen with titanium implants today.


   FOOTNOTES
 

Address reprint requests to the ADA Council on Scientific Affairs, 211 E. Chicago Ave., Chicago, Ill. 60611.


The ADA Council on Scientific Affairs thanks Clark Stanford, D.D.S., Ph.D., University of Iowa, College of Dentistry, Iowa City, and Jeffrey Rubenstein, D.M.D., M.S., University of Washington, School of Dentistry, Seattle, for their contributions to this report.


   REFERENCES
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 ABSTRACT
 FUTURE DIRECTIONS
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T. A Gerds and M. Vogeler
Endpoints and survival analysis for successful osseointegration of dental implants
Statistical Methods in Medical Research, December 1, 2005; 14(6): 579 - 590.
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