Response to De Bruyn H, Collaert B, Linden U, Johansson C, Albrektsson T: Clinical outcome of Screw Vent implant. Clin Oral Impl Res 1999;10:139-148.

July 29, 1999

Prof. Dr. Dr. H.C. Niklaus P. Lang, MS

University of Berne

School of Dental Medicine

Department of Periodontology

and Fixed Prosthodontics

Freiburgstrasse 7

CH-3010 Berne

Switzerland

Dear Dr. Lang:

SUBJECT: Invalidity of the study by De Bruyn, Albrektsson et al., entitled "Clinical outcome of Screw-Vent implants– A 7-year prospective follow-up study" 1999 Clinical Oral Implant Research 1: 139-148, ("De Bruyn, Albrektsson 1999 study").

HISTORY: This is a follow-up study to a 1-year study published in the same journal by De Bruyn et al. 1992 Clinical Oral Implants Research 3:32-41 ("De Bruyn 1992 study") that reported on a comparison of "the clinical success of 85 Screw-Vent and 107 Branemark implants, consecutively installed in a private periodontal clinic under the same conditions and by the same operator." Unlike the 1999 study, the original one included evaluation of Branemark implants placed by the same periodontist.

1999 STUDY CRITERIA: claims to use a bone loss criteria of success first proposed by Albrektsson et al (JOMI 1986) and later adopted by the European Academy of Periodontology (Albrektsson & Isidor 1994).

1. Co-author, Thomas Albrektsson (MD) is a paid consultant and/or spokesman for Nobel Biocare, a company selling competing products to Paragon’s Screw-Vent Implant.
2. Albrektsson devised the success criteria that includes a bone loss parameter and, in this study, applies these criteria to conclude that "the Screw-Vent implant does not meet with the success criteria".
3. Albrektsson, as a non-dentist and, had no involvement with conducting the clinical aspects of this study, and was not a co-author of the original comparative study – why is he now involved with this study?
4. The De Bruyn 1999 "7-year prospective follow-up study" reported on 85 Screw-Vent implants first reported in De Bruyn 1992 article, but excludes the 107 Branemark implants. The explanation given by the authors for this exclusion is that "…we felt that plenty of evidence is available to validate the Branemark system." No references are offered in support of this assertion.
5. A search of the literature has not revealed any published studies on the Brånemark implant that has utilized Albrektsson et al.'s criterion of 0.2mm annual crestal bone loss. Adell et al.’s 15-year (Int J Oral Surg 1981) and 20-year (JOMI 1990) reports, and Zarb’s 9-year report (Int J Perio Rest Dent 1991) do not utilize bone loss as a criterion for determining the success of Brånemark implants. Albrektsson et al. (Int J Prosthodont 1993) acknowledge that the 20-year report on the Brånemark implant by Adell et al. (JOMI 1990) "did not, for practical reasons, make individual radiograms, nor did they perform individual stability controls in every long-term follow-up patient."
6. The subsequent replication study of the Brånemark research (Chaytor & Zarb, Int J Periodont Rest Dent 1991) calculated marginal bone change as an average of bone losses and bone gains over time, but did not include bone loss as a criterion of implant success. While one later study of Brånemark implants placed in 50 patients (Zarb & Schmitt, JADA 1996) states that annual follow-up examinations included tests for implant mobility and soft tissue attachment in accordance with the proposed Albrektsson et al. success criteria (JOMI 1986), implant survival (i.e. osseointegration) was the only criterion utilized to determine implant success in the study.
7. Selectively applying Albrektsson et al.'s success criterion to a competitor's implant without applying the same criterion to the Brånemark implants placed in the same study is an established tactic of Brånemark spokesperson, Sennerby (JOMI 1990), when he was a graduate student of Albrektsson, which has been criticized in the literature (Niznick, JOMI 1990).
8. The Brånemark researchers calculated bone loss from the subcrestal base of a 2-mm-deep countersink preparation (Adell et al., Int J Oral Surg 1981), rather than from the crest of the ridge at the time of implant placement, and those measurements did not commence until one year after the implant was loaded with the prosthesis. In the present study by De Bruyn, Albrektsson et al., bone loss was measured only for the Screw-Vent implant, and was calculated from the crest of the ridge at the time of implant placement.
9. Albrektsson et al.'s criterion of 0.2mm annual bone loss after the first year in function (JOMI 1986) is not only based on average bone loss measurements made from the base of the countersink (Adell et al., Int J Oral Surg 1981), but also exclusively derived from implants splinted cross-arch in the symphysis of completely edentulous jaws (Brånemark et al., Tissue-Integrated Prostheses 1985). The reality is that periimplant crestal bone loss is an extremely complex phenomenon that can be caused by many different factors, including surgical trauma, inappropriate selection of implant size and location of placement, smoking habits of patients, excessive loading conditions and microbial infections, to name a few. Crestal bone change can range between bone losses and bone gains over time (Chaytor & Zarb, Int J Periodont Rest Dent 1991; Manz, JOMS 1997;55,Suppl 5), and are thus not necessarily indicators of either implant success or implant failure.
10. Although a number of published studies reference the Albrektsson criteria of success that included no greater bone loss than 0.2mm annually after the first year in function, none exist where bone loss exceeding the recommended minimum acceptable level was used as a determining factor in judging an individual implant a clinical failure. To date, the Albrektsson bone loss criterion has only been applied to implants that compete with the Brånemark implant by either Albrektsson, or Sennerby, both spokesmen for Nobel Biocare (JOMI 1990 Sennerby: Evaluation of 43 Core-Vent Implants; Albrektsson, Int J Prosth. IMZ implants and the current De Bruyn, Albrektsson study – Screw-Vent Implants).
11. The Albrektsson/Zarb Criteria of Success (Albrektsson T, Zarb G et al. JOMI 1986) included a requirement that crestal bone loss be "less than 0.2mm annually after the implant's first year of service." The De Bruyn 1999 study acknowledges in its first paragraph that the De Bruyn 1992 study reported one-third of the examined Screw-Vent implants "showed bone loss between 2 and 4mm." Instead of applying the criteria as stated, and using the individual implant's bone loss measurement "after the implant’s first year of service" as the baseline to determine whether a steady state with no greater than an average of 0.2mm annually for subsequent years, the De Bruyn 1999 study allowed an arbitrary 1.5mm for first year bone loss. The De Bruyn 1999 study then

added 0.2mm for each of the remaining 6 years of follow-up to reach what it terms the

"critical bone loss value" of "2.7mm below abutment implant junction, which

corresponds by coincidence to the first implant thread" of the Screw-Vent implant.

12. The De Bruyn 1992 study reported that, for the Branemark implant, "bone remodeling in the coronal part of the implant, up to the 1^st implant thread." The article notes that the "non-threaded area of the (Brånemark) fixture is 1.5mm up to the first thread." With the Screw-Vent implant, De Bruyn 1992 observed "the mean 1.7mm bone loss (Screw-Vent) is counted from the baseline radiographs taken at the time of abutment connection, and does not reflect the real abutment-bone distance or bone loss prior to abutment connection... The bone level is directed towards the first implant thread, about 2.7m mm below the implant-abutment interface. "
13. Bone loss that takes place in the first year following placing the implant in function was to be specifically excluded in applying the Albrektsson Criteria to account for bone loss due to surgical trauma, resorption of thin bone, or bone loss from excessive functional forces. Its claimed objective was to ascertain if a steady state would be reached by a particular implant design. The De Bruyn 1992 study points out that with the "Screw-Vent implants, there is no need for countersinking as with the Branemark System." Countersinking widens the opening to the implant site, removing thin bone that would otherwise be lost from resorption. The Screw-Vent (pre-1995) had a 2mm relatively smooth neck created by acid etching the machined surface.
14. The initial differences in bone loss from the Screw-Vent without countersinking and the Branemark, with countersinking, would be accounted for if the authors applied the Albrektsson 1986 criterion as stated: "less than 0.2mm annually after the implant's first year of service." Instead, the authors arbitrarily allowed 1.5mm for the first year bone loss for the Screw-Vent in spite of the fact that Albrektsson was not only a co-author of this article but also of the criteria applied by the article. The authors’ failure to properly apply the criteria, and at the same time, to apply the same criteria to the Branemark implants in the same study group, invalidate the study and reveal the intentions of the authors to create a marketing attack on one of Nobel Biocare’s competitors.

This Technology Report is being prepared to evaluate the scientific objectivity of this article, and to critically analyze the validity of using the Albrektsson criteria of success that, as will be demonstrated, has undergone repeated modifications since first proposed. (Albrektsson et al., JOMI 1986).

The core issue raised by the present De Bruyn, Albrektsson et al. article (COIR 1999:10) is the legitimacy of applying the Albrektsson et al. bone loss criteria to evaluate any implant system. De Bruyn, Albrektsson et al. essentially assert that the Screw-Vent implants, which were successfully osseointegrated and in function for 7 years, must be called failures if bone recession occurs to the first thread. By not applying the same criterion to the Brånemark implants placed in the same study, the authors eschew the fact that the same degree of crestal bone loss is routinely observed with Brånemark implants (Adell et al., Int J Oral Surg 1981; Lindquist et al., JPD 1988).

The De Bruyn 1999 article cites a number of references to support criticism of the Screw-Vent implant’s design, surface and clinical efficacy, but a review of these studies reveals an alarming discrepancy between what the referenced articles actually state. Most readers rely on the honesty of the authors and the thoroughness of the reviewers. The following comparisons of what the authors claim the reference reported, and what they actually state, should serve as a shocking example of how researchers or clinicians, affiliated with a company as a researcher and/or lecturer, can disguise marketing rhetoric in the form of

pseudoscience. Albrektsson, with financial ties to Nobel Biocare, has demonstrated this type of intellectual dishonesty in many of his previously published articles critical of Nobel Biocare’s competitors. He has done it again in this article:

The requirement that implants not exhibit more than 0.2mm of annual crestal bone loss after the first year of placement as a criterion of success was proposed in 1986 (Albrektsson,

Zarb et al. JOMI 1986), by co-author, Dr. Tomas Albrektsson, a Nobel Biocare consultant and spokesman. It has undergone a number of modifications in published articles since that time although, to date, not a single published study on the Brånemark implant that has ever utilized the Albrektsson/Zarb criterion of crestal bone loss for determining success or failure of a single implant. For example, Adell et al.’s 15-year (Int J Oral Surg 1981) and 20-year (JOMI 1990) reports, and Zarb’s 9-year report (Int J Perio Rest Dent 1991) did not utilize bone loss as a criterion for categorizing Brånemark implants as failures. Albrektsson et al. (Int J Prosthodont 1993) admit that the 20-year report on the Brånemark implant by Adell et al. (JOMI 1990;5:347) "did not, for practical reasons, make individual radiograms, nor did they perform individual stability controls in every long-term follow-up patient.

The real issue raised by the De Bruyn, Albrektsson article is not the bias of the authors, which is obvious from their inaccurate extrapolation from various references to portray the Screw-Vent implant in a poor light. It is the use of the Albrektsson bone loss criteria to evaluate any implant system. The following history of this criteria and the illogic of its application should provide a better understanding of how it’s application serves no valid purpose.

The De Bruyn, Albrektsson study established the benchmark level of bone loss they say is acceptable for the Screw-Vent by adding 1.5mm allowance for bone loss during the first year in function, and 0.2mm for each of the 6 years of follow-up, for a maximum of 2.7mm, which they acknowledge "corresponds by co-incidence with the first implant thread." The average bone loss was reported as being 2.92mm with "18 of 60 examined implants (30%) showed unacceptable radiological bone loss beyond the critical value of 2.7mm." Therefore, bone loss to or beyond the first thread was considered "unacceptable."

In contrast, bone loss with the Brånemark implant has been measured from the base of the countersink (Adell 1981), which is 1.5mm from the top of the implant. Brånemark, Albrektsson and Zarb (1985 Quintessence Textbook, Pg 181) reported an additional "1 to 1.5mm of marginal bone was lost during the first year after bridge connection, mainly as a response to the surgical trauma. This combined surgical removal by countersinking and subsequent bone loss totals 3mm and results in exposure of the first thread of the Branemark implant on a routine basis. Countersinking the crestal bone for the Branemark implant has the effect of widening the ridge by removing thin crestal bone that would eventually resorb. The Screw-Vent implants, with necks narrower than their outside threads, do not require countersinking, thereby preserving crestal bone initially and allowing the bone to resorb naturally.

Therefore, both the Branemark and Screw-Vent implants may lose bone to the first thread (3mm from top on the Branemark implant and 2.7mm from the top with the older Screw-Vent design used by De Bruyn) but according to the Albrektsson criteria, the Screw-Vent design would be considered a failure while the Branemark implant would be considered a success. The article states that the Albrektsson criteria has been accepted by the European Academy for Periodontology. The time has come for such organizations to review the history of, and modifications to, the Albrektsson criteria and question what purpose such criteria serve, other than for clinicians and researchers affiliated with Nobel Biocare to criticize competitors' products.

1986: The Albrektsson/Zarb Criteria of Success (Albrektsson T, Zarb G et al. JOMI 1986) included a requirement that crestal bone loss be "less than 0.2mm annually after the implant's first year of service." The 0.2mm bone loss after the first year in function was

based on an average bone measurements of implants splinted cross-arch in the symphysis of totally edentulous jaws (Branemark 1977 textbook).

1989: Following the reports of the University of Toronto replication study (Smith D, Zarb G et al., J Prosthet Dent 1989;62(5):567-572), Zarb modified this criterion by adding the proviso that: "Complications of an iatrogenic nature that are not attributable to a problem with material or design should be considered separately when computing the percentage of success."

Considering the long list of "complications of an iatrogenic nature" that can affect crestal bone loss, one should legitimately question how such a criterion could ever be applied to determine clinical success. Certainly this article provides no disclosure of any such complications, nor is it always possible to determine when such complications of an iatrogenic nature were the cause of the bone loss. A partial list of iatrogenic causes of crestal bone loss would include:

• Selection of too wide an implant diameter for the ridge width.
• Failure to prepare the surgical site to accept the diameter of implant selected, such as by flattening the ridge to remove thin crestal bone or ridge augmentation.
• Improper positioning of the implant too far to the labial, resulting in an unacceptably thin labial plate, or fracture of the labial plate during insertion.
• Variabilities of bone quality --- Studies show different qualities of affect bone loss. Manz M. Radiographic assessment of peri-implant vertical bone loss: DICRG J Oral Maxillofac Surg 1997;55(Suppl 5):62-71.
• Variable of Occlusal Forces

• Surgical Errors: Overheating, dehiscense
• Poor oral hygiene.

1991: The report on the results of the University of Toronto Branemark Implant Study, (Chaytor D, Zarb G.: Int J Perio Rest Dent 1991; 11(2):113-125) tried to reconcile their observations with the Albrektsson/Zarb Bone Loss Criteria by evaluating average bone loss within a single patient:

1993: Chaytor provides a common sense approach to the validity of applying annual bone loss as a criterion of success (Chaytor D: Int J Prosthodont 1993;6(2):95-105.):

The VA study measured thickness of labial plate at time of implant placement and determined correlation between bone thickness and reduced crestal resorption (in manuscript). One analysis of data from the VA study (Manz M. Radiographic assessment of peri-implant vertical bone loss: DICRG. J Oral Maxillofac Surg 1997;55(Suppl 5):62-71) confirmed that bone loss was related to implant surface (less with HA coating 1/2mm from top), quality of bone (less in dense bone) and location in the jaw (greater in thin bone in anterior maxilla). Given all the iatrogenic causes of bone loss, many caused by inexperience of the surgeon, and its relationship with surface roughness, bone quality and ridge thickness, to judge an implant as meeting success criteria based on bone loss measurements is ludicrous, especially when reported by relatively inexperienced clinicians from one center with an affiliation to a competing company. Such reports should not pass peer review, or for that matter, the smell test!