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

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.

Conditions

• Jaw, Edentulous

Interventions

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)

Sponsors & Collaborators

• Université de Montréal

  lead OTHER

Principal Investigators

• Aldo J Camarda, DDS, MSc · Université de Montréal

• Robert Durand, DMD, MSc · Université de Montréal

• Marwa Benkarim · Université de Montréal

• Pierre Rompré, MSc · Université de Montréal

• Geneviève Guertin, DMD, MSc · Université de Montréal

• Hugo Ciaburro, DMD, MSc · Université de Montréal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

48 Years

Max Age

82 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-03

Primary Completion

2019-08-16

Completion

2019-12-31

FDA Device

Yes

Countries

• Canada

Study Locations