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Prospective Randomized Clinical Trial Comparing Quantitative Osseous Healing of Acid Etched and Machined Titanium Implant Fixtures After 12 and 24 Months, and at 15-20 Years of Function With Full Arch Fixed Mandibular Prostheses.
Sponsor study identifier
interventional
58
1 country
1
Study Start
March 1992
Actual (reported)Primary Completion
March 24, 1998
Actual (reported)Study Completion
September 30, 2013
Actual (reported)Brånemark System® dental implant osseointegration was introduced clinically in 1965 as a novel approach to the replacement of missing teeth. Although this implant's traditional machined screw-shaped surface had excellent, well-documented short- and long-term osseointegration success, newer implant designs were introduced that could enhance biological fusion of the implant to jaw bones, allowing more rapid restoration and function. It was also claimed that such implants could lead to less bone loss with function. One such implant, Screw-Vent®, had a macrostructure very similar to that of the Brånemark implant, except that it's fixture surface was acid-etched which could enhance biological osseointegration. It also had a longer narrower smooth internal-hex interlocking flat collar that could better resist occlusal forces, leading to even less bone loss according to the manufacturer. However, no well-controlled clinical studies existed in 1990 that supported these claims. This study was undertaken, therefore, to first compare the Brånemark implant with another implant, Swede-Vent®, a copy of the Brånemark implant except for its fixture surface that was identically acid-etched 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 acid-etched surfaces in the short- and long-terms. Our hypothesis was that the microtextured Swede-Vent fixture would lead to greater bone preservation. Since Screw-Vent's fixture surface was identically acid-etched as that of Swede-Vent by the same manufacturer, we could then evaluate the effect on bone healing of Screw-Vent's collar and the shorter wider machined smooth external-hex flat collar of Swede-Vent (identical to that of Brånemark). All three 2-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 is still available, but with an oxidized microtextured fixture surface and a shortened machined smooth external-hex flat collar. Screw-Vent is still available with its microtextured fixture surface, but its machined smooth internal-hex flat collar has also been substantially shortened. Swede-Vent is no longer available.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1992
Actual (reported)March 24, 1998
Actual (reported)July 6, 2012
Actual (reported)July 16, 2012
Actual (reported)September 30, 2013
Actual (reported)January 16, 2019
Actual (reported)Comparison of Quantitative Bone Healing
Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest was measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded after 12 months of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3
After 12 months of function
Comparison of Quantitative Bone Healing
Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded after 24 months of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3
After 24 months of function
Comparison of Quantitative Bone Healing
Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded at 15 to 20 years of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3
At 15-20 years of function
Device placement: B (Brånemark) at two sites, SW (Swede-Vent) at two sites, SC (Screw-Vent) at one site
Device placement: B (Brånemark) at one site, SW (Swede-Vent) at two sites, SC (Screw-Vent) at two sites
Device placement: B (Brånemark) at two sites, SW (Swede-Vent) at one site, SC (Screw-Vent) at two sites
B placed at sites 2 and 5, SW placed at sites 1 and 4, SC placed at site 3
B placed at site 3, SW placed at sites 2 and 5, SC placed at sites 1 and 4
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Université de Montréal
Montreal, Quebec, H3C 3J7, Canada
Patrice Milot, DMD,MSD
Université de Montréal
Hugo Ciaburro, DMD, MSc
Université de Montréal
Aldo-Joseph Camarda, DDS, MSc
Université de Montréal
58 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2012
First Posted
July 16, 2012
Study Start
March 1992
Actual (reported)B placed at sites 1 and 4, SW placed at site 3, SC placed at sites 2 and 5
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
March 24, 1998
Actual (reported)Study Completion
September 30, 2013
Actual (reported)Last Updated
December 17, 2020
Results First Posted
January 16, 2019
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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