PubMed1975
To briefly summarize our results, two of the five three-pin staples (40%) have survived and have functioned well for more than six years. Four of the five four-pin staples (80%) have survived five years or longer and are functioning well. Twenty-four of the 25 seven-pin staples (96%) are functioning well, some for a period of 4-1/2 years; a few in this group have been used a little less than a year. Our total percentage of survival with good function is 30 of 35, or 86%, which includes our pilot study of the three- and four-pin staples. A more significant statistic, however, might be those patients with staples who we feel have been free of any significant trouble; these are 27 of 35, or 77%. All of our patients have been subjected to peer review examination and grading by members of the oral surgery staff at Sinai Hospital. They were examined and graded according to three criteria. The first was clinical appearance which included firmness of the staple and clinical appearance of the gingiva (Fig 16). The second was radiographic evidence of bone loss along the transosteal pins and retentive pins (Fig 17). The third category was patient evaluation of improved function and stability of the lower denture (Fig 18). The peer review group used marks A, B, C, D, as excellent, good, fair, and failure. Four points were assigned to A, 3 points to B, 2 points to C, and 1 point to D, so that the grade averages for all three categories were as follows: clinical appearance, 3.6; radiographic appearance, 3.5; and patient evaluation, 3.9. The conclusion of the review group was that the mandibular staple was functioning well and that it was clinically useful. I have presented an overview of some of the characteristics of metallic implants that make them implantable devices, and some of the qualities of the host tissues that will allow placement of foreign material. We do not yet understand all of the factors that make alloplastic materials biocompatible or some of the reasons for rejection by the host. We need continued research in animal models to study new devices and new materials that might permit biologic attachments of the host to implant. We also need controlled clinical studies with peer review to establish reliability of those devices that are clinically useful. The mandibular staple has had an initial clinical trial that seems very promising and is worthy of continued clinical study and clinical application.