CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1) +2 moredevice
Likely dose
Not stated in record
Key inclusion· 4
  • Non-smoker status
  • No temporomandibular joint (TMJ) disorder or facial pain history
  • Prior participation in the original study conducted 1993-1996
  • Original study age at enrollment: minimum 25 years, maximum 56 years
Key exclusion· 1
  • Refusal to sign informed consent documents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03862482
NCT03862482N/ACompleted

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

Université de Montréal·interventional·Posted Mar 5, 2019·Updated Jun 14, 2021

In Brief

A clinical study evaluating Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1), Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2), and 1 other intervention for Jaw, Edentulous. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJaw, Edentulous
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 5, 2019
Enrollment StartJun 3, 2019
Primary CompletionAug 16, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.3 years ago

Interventions

Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)device

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)

Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)device

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)

Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)device

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)