IMPLANT HARDWARE— SCIENCE OR COMMODITY DEVELOPMENT?

Historically, the field of dental implantology has been more akin to an art form rather than being a scientifically based discipline. The advent of the concept of osseointegration resulted in the dental establishment’s eventually accepting the dental implant as a predictable clinical reality for longterm use in selected cases.

This was because osseointegration, ad modum Branemark, emerged from a basic science laboratory background and was subsequently exhaustively evaluated in animal studies, limited pilot studies, and controlled multi-center long-term prospective clinical trials, before being eventually released for clinical use.

The clinical users were required to undergo formal training and education in all aspects of both the software and hardware associated with this new modality. Perhaps the most salient feature of the development was the fact that the basic science laboratory background was a medically based bio-engineering one, and the dental involvement in the project was irrelevant and non-existent in the beginning.

The original basic science development of the 1970’s led to refinement and application of the surgical techniques, resulting in the predictably high success rates achieved in widespread clinical application in the 1980’s. The 1990’s have seen an emphasis focused on dental implant esthetics together with expanded clinical applications, ranging from the missing single tooth to complex multi-disciplinary management of the extensive orofacial cancer defect, in orthodontics, and finally under controlled circumstances in specific cases in pediatric dentistry.

Thus, at the present time, we see the area of applied osseointegration as the fastest growing area of clinical practice. Unfortunately, as is the case with many things growing too fast, it is now almost out of control. One major area of concern is the increasing emphasis on esthetic perfection, placing unrealistic timeframe demands on the development of implant abutment components. The concomitant expansion of hard and soft tissue augmentation technology required to achieve the optimal environment for the prosthetic superstructure has enhanced this concern.

A fundamental reason for this is that the basic requirements for organized research, development, and evaluation of new clinical devices and procedures which are of little concern to most practicing dentists are not being enforced by the establishment and are not as yet adequately controlled by regulatory bodies. The impetus behind this situation has been the development of a “commodity market” in dental implants.

Commodity development implies that the market accepts hardware versions without documentation specific to that version. That is to say, development is designed to be generic.

The advantage of generic development is one of great commercial significance, because it means that devices, products, and materials can be promulgated by extrapolation. However, this is unacceptable scientifically. Furthermore, it is ethically questionable and, unfortunately for the end-user, the patient, can be disastrous in the long term, both biologically and fiscally, in the event of treatment failure. It is appropriate to review the mechanism of commodity development and to evaluate how it can be controlled in the best interests of health and welfare.

The key to this issue is research, or, more precisely, the lack of it. Commodity development takes place continuously and has as its genesis a gradual degradation of the original concept, resulting in loss of respect for the fundamentals of the concept. This degradation is often excused on the basis of its being a proposed improvement-for example, in certain aspects of hardware-but can in fact be counterproductive.

An example of this is seen in the case of hydroxyapatite-coated implants, where promising, but deceptive, short-term results are now being refuted by long-term data, resulting in some such products being withdrawn from the market, leaving many patients compromised and many shortsighted clinicians with long-term practice management problems.

Initially, commodity development was concentrated on implant design and surface microstructure, but more recently has had an impact on abutment design and material, resulting in the market’s becoming inundated with a kaleidoscope of untested products. Factors of prosthetic flexibility, interchangeability, convenience, and cost have been given as reasons to justify this phenomenon. Accordingly, this has posed the question, “What scientific proof does the restorative clinician have that intersystem hardware components are interchangeable without potential harm to long-term implant survival and dental health?” The consensus is that there is none.