A prospective multicenter clinical trial comparing one- and two-stage titanium screw-shaped fixtures with one-stage plasma-sprayed solid-screw fixtures.

BACKGROUND

Brånemark fixtures were originally placed in two stages, whereas titanium plasma-sprayed (TPS) solid-screws are placed in one stage. Long-term survival rates for both types of implants are excellent. Excellent survival rates have also been reported for machined screw-shaped (MS) titanium implants placed in one stage. A small number of studies have compared different implant systems and methods of implant placement.

PURPOSE

The purpose of this study is to report clinical outcomes from a prospective longitudinal, multicenter study comparing Brånemark MS fixtures (Nobel Biocare, Yorba Linda, California, USA) placed in either one or two stages with a one-stage TPS system (ITI Straumann, Waldenburg, Switzerland).

METHODS

A protocol was designed to compare implant survival rates, changes in crestal bone for titanium MS fixtures placed in one and two stages, and plasma-sprayed solid-screw fixtures placed in one surgical stage. Twenty-nine patients ranging in age from 24 to 82 years received MS fixtures in one stage. The average age for males was 58 years (n = 11), whereas the ages for females (n = 18) ranged from 15 to 84 years (average 58 years). Twenty-nine patients received machined titanium fixtures placed in two stages. There were 20 females ranging in age from 23 to 74 years (average 54 years) and 9 females ranging from 24 to 74 years (average 46 years). Twenty-five patients received TPS fixtures. There were 15 males, ranging in age from 57 to 79 (average 70), and 10 females, ranging in age from 40 to 83 years (average 62 years). Bone quality and quantity were determined from radiographs and during site preparation. Patient age, sex, location of implant placement according to jaw, length of fixtures, and number of lost fixtures were entered onto computer code sheets and continuously entered into a locked computer system. For one- and two-stage MS fixtures, nonstandardized periapical radiographs were taken at abutment connection and follow-up. Solid screws were x-rayed at prostheses connection and follow-up. The average time between implant restoration and radiographic follow-up was 15 months. The x-rays were scanned into a computer, and a program designed to measure radiographs was used to determine changes in crestal bone. Measurements for one- and two-stage MS fixtures were made from the top of the implant shoulder to the first bone to implant contact mesial and distally. Plasma-sprayed screws were measured from the bottom of the implant to the coronal most bone to implant contacts mesial and distally. Mesial-distal radiographic measurements were averaged and changes were compared using the t-test for related samples.

RESULTS

This report presents data from the 2- to 3-year follow-up examinations. Twenty-nine patients received 80 one-stage MS fixtures. Between 0 and 1 year, two fixtures were lost, resulting in a 97.5% cumulative survival rate (CSR). The CSR remained unchanged through the 2- to 3-year follow-up. Twenty-eight patients received 78 two-stage MS fixtures. One implant was lost prior to loading and two were lost between 0- and 1-year follow-up, yielding a 96.2% CSR at the end of 1 year. The CSR remained unchanged through the 2- to 3-year follow-up. Twenty-three patients received 78 solid-screw plasma-sprayed screws. One implant was lost prior to loading and one between the 0- to 1-year follow-up, accounting for a 97.4% CSR at the 2- to 3-year follow-up. Changes in bone crest measurements for one-stage titanium threaded fixtures were insignificant (-0.11 mm, p = .08, maxillary; 0.07 mm, p = .42, mandibular). For two-stage MS fixtures, crestal bone loss was insignificant in maxillae (-0.16 mm, p = .92) and significant in mandibles (-0.43 mm, p = .000). There was significant bone loss for TPS implants in maxillae and mandibles (maxillae, 1.31 mm, p = .04; mandibles, 0.98 mm, p = .000).

CONCLUSIONS

Cumulative survival rates for MS fixtures placed in one and two stages as well as one-stage TPS screws up to the 2- to 3-year follow-up examination were similar, indicating excellent clinical results. Radiographic measurements for changes in crestal bone loss were clinically insignificant for fixtures placed in one stage. For two-stage fixtures, maxillary changes were insignificant, whereas mandibular bone loss was statistically significant but clinically insignificant. Changes in crestal bone loss for TPS implants were statistically significant.