Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function - Trial NCT03862482

Timeline & Enrollment

Primary Outcome

Comparison of Distance Between First Bone to Implant Contact Point (fBIC) and Microgap (MG), After 25 Years of Function, Between All B, All SW, and All SC Dental Implant Units in All Three Configurations

Summary

Brånemark System® dental implant osseointegration was introduced in 1965 as a novel approach
 to the replacement of missing teeth. Although this implant's machined, screw-shaped surface
 had excellent, well-documented, short- and long-term clinical success (Adell, R. 1987;
 Albrektsson, T., et al., 1981; Albrektsson, T., et al., 1986; Brånemark, P-I. , 1983;
 Brånemark P-I. 1987), newer implant designs were introduced that could enhance fusion of the
 implant to jaw bones, and better resist functional forces. One such implant, Screw-Vent®, has
 a fixture macro structure very similar to that of the Brånemark® implant. However, its
 fixture surface was acid etched (1-3µm) which could enhance osseointegration, and it has a
 longer, narrower machined internal-hex, friction-fit collar that could better resist
 functional forces.These characteristics should lead to less bone loss (Niznick, G. A., 1989).
 However, one clinical study (De Bruyen, et al., 1992) reported greater short-term bone loss
 with this implant compared to the Brånemark® implant, possibly due to its longer machined
 collar, and advocated long-term clinical studies. Therefore, this prospective within-subject
 clinical trial was undertaken in 1993 to first compare the Brånemark® implant with another
 implant, Swede-Vent®, a copy of the Brånemark® macro structure except for its fixture surface
 that was identically micro textured as that of Screw-Vent® by the same manufacturer. The
 effect on bone healing could then be compared between Brånemark®'s machined and Swede-Vent®'s
 micro textured fixture surfaces in the short- and long-terms. Since Screw-Vent®'s fixture
 surface was identically micro textured as that of Swede-Vent®, the investigators could then
 evaluate and compare the effects on bone healing of Screw-Vent®'s longer, narrower,
 internal-connection machined collar to the identical shorter, wider, external-connection
 machined collars of the Swede-Vent® and Brånemark® implants. All three two-part,
 platform-matched, parallel-wall implants were made of commercially pure titanium, had a very
 similar fixture macro design, were approved by the Food and Drug Administration (USA) and
 Health and Welfare Canada, and were commercially available in North America. Brånemark® and
 Screw-Vent® implants are still available, but the Swede-Vent® implant is not.

ICD-10 Classifications