NCT03862482

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

Prospective Randomised Clinical Trial Evaluating the Effects of Two Different Implant Collar Designs on Peri-Implant Healing and Functional Osseointegration After 25 Years of Function With Full Arch Mandibular Prostheses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Université de Montréal · Academic / Other
• Sex: All
• Age: 48 Years – 82 Years
• Healthy volunteers: Accepted

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.

Detailed description

Therefore, between 1993 and 1996, 58 of 60 eligible participants had been recruited into a prospective, randomized clinical trial. This trial had been peer reviewed, had received ethical approval, and had taken place at the Université de Montréal's Faculty of Dental Medicine and its affiliated hospital dental department. Follow-up documentation occurred at one year, two years, and 15 to 20 years following prostheses attachment (ClinicalTrials Identification Number NCT01641198), and the results were published (Camarda, et al., 2018). The present study reports on data collected at the 25-year (24.6 ± 0.19 years, mean ± SE) follow-up (ClinicalTrials Identification Number NCT03862482), focusing specifically on the evaluation and comparison of the effects on peri-implant healing and functional osseointegration of the two different machined collar designs. That is to say, the identical shorter, wider, external-connection Brånemark® and Swede-Vent® collars versus the longer, narrower, internal-connection Screw-Vent® collar. Twenty-two of the original participants (41.5%, age 71.1 ± 1.2 years, 11 women, 110 implants) were enrolled into this study. All study procedures were performed in accordance with the Helsinki Declaration and its later amendments, and all participants signed informed consent documents prior to inclusion into this study.

Conditions

• Jaw, Edentulous

Interventions

Type	Name	Description
DEVICE	Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)	Brånemark® implant placed at sites 2 (left medial) and 5 (right distal), Swede-Vent® implant placed at sites 1 (left distal) and 4 (right medial), Screw-Vent® implant placed at site 3 (para symphysis)
DEVICE	Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)	Brånemark® implant placed at site 3 (para symphysis), Swede-Vent® implant placed at sites 2 (left medial) and 5 (right distal), Screw-Vent® implant placed at sites 1 (left distal) and 4 (right medial)
DEVICE	Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)	Brånemark® implant placed at sites 1 (left distal) and 4 (right medial), Swede-Vent® implant placed at site 3 (para symphysis), Screw-Vent® implant placed at sites 2 (left medial) and 5 (right distal)

Timeline

• Start date: 2019-06-03
• Primary completion: 2019-08-16
• Completion: 2019-12-31
• First posted: 2019-03-05
• Last updated: 2021-06-14
• Results posted: 2021-06-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study