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N/A N=22 Randomized Triple-blind Treatment

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

Jaw, Edentulous

Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Comparison of Distance Between First Bone to Implant Contact Point (fBIC) and Microgap (MG), After 25 Years of Function, Between All B, All SW, and All SC Dental Implant Units in All Three Configurations — -0.85; -1.00; -1.77 mm — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1) (Device); Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2) (Device); Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3) (Device)
Age
Adult, Older Adult · 48+ yrs
Sex
All
Sponsor
Université de Montréal
Primary completion
Aug 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Comparison of Distance Between First Bone to Implant Contact Point (fBIC) and Microgap (MG), After 25 Years of Function, Between All B, All SW, and All SC Dental Implant Units in All Three Configurations
-0.85; -1.00; -1.77 <0.05 sig
SECONDARY
Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function
0; 0; 0
SECONDARY
Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function
0.67; 0.51; 0.74
SECONDARY
Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function
2.09; 2.34; 2.29
SECONDARY
Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function
0.40; 0.42; 0.43; 0.48; 0.47; 0.44
SECONDARY
Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function
0; 1; 0

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.

Eligibility Criteria

Inclusion Criteria

  • non-smoker
  • no temporomandibular joint (TMJ) disorder or facial pain
  • having participated in the original study (1993 - 1996) at which time the minimum participants' age was 25 years and the maximum 56 years

Exclusion Criteria

  • refusal to sign informed consent documents
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03862482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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