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NCT Number: NCT03862482

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

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.

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Key information

Conditions

Jaw, Edentulous Jaw Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

48 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Montréal

Montreal, Quebec, H3C 3J7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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

    Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function

    Distance between first bone-to-implant contact point (fBIC) and microgap (MG) at the crest was measured (mm) at mesial and distal sides of each implant/abutment complex on conventional peri-apical radiographs using a standardized equipment and measurement protocol (Camarda, et al., 2018) after 25 years of function. Values fBIC-MG (Mean ± SE) ("-" for bone loss) were calculated, recorded and compared between all B and all SW, between all B and all SC and between all SW and all SC dental implant units in all three Configurations

Secondary outcomes

  1. Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function

    Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function

    Mobility was measured by applying manual pressure on the handles of two instruments, each placed on opposite sides of the prostheses and abutments, and was recorded as 0 (no mobility or looseness) or 1 (mobility or looseness). Values (Mean ± SE) were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1 (Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1), Configuration 2 (Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2), and Configuration 3 (Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2)

  2. Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function

    Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function

    Height of the keratinized tissue was measured (mm) using a ColorVue UNC12 Hu-Friedy probe on the buccal and lingual implant/abutment surfaces. Values (Mean ± SE) were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1 (Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1), Configuration 2 (Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2), and Configuration 3 (Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2)

  3. Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function

    Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function

    Using a ColorVue UNC12 Hu-Friedy probe, probing depth was measured (mm) on the buccal, lingual, mesial and distal implant/abutment surfaces. Values (Mean ± SE) were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1(Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1), Configuration 2 (Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2), and Configuration 3 (Brånemark® 2, Swede-Vent ®1, Screw-Vent® 2)

  4. Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function

    Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function

    Absence (0) or presence (1) of plaque and/or gingival bleeding on probing was evaluated using the dichotomous/binary plaque index (dPI) (Galgut, P. A., 1999) and bleeding index (dBI), respectively (Galgut, P.A., 1999). Values (Mean ± SE) were compared between B and SW, between B and SC and between SW and SC for Configuration 1 (Brånemark® 2, Swede-Vent® 2, Screw-Vent ®1), Configuration 2 (Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2), and Configuration 3 (Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2)

  5. Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function

    Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function

    Absence (0) or presence (1) of purulent exudate on probing was evaluated. Values (Mean ± SE) were recorded, and compared between B and SW, between B and SC and between SW and SC for Configuration 1 (Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1), Configuration 2 (Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2), and Configuration 3 (Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2)

Other outcomes

  1. Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years of Function

    Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function

    Conventional peri-apical radiology and phosphor-plate digital technology (Digora System™, Digora OptimeTM, Sporedex Dental Co., Tuusula, Finland) were used with the standardized equipment to take peri-apical radiographs on 95 implant/abutment units (Camarda, et al., 2018; Bhaskaran, et al., 2005). Following calibration, the distance between the first-bone-to-implant-contact-point and the crestal-microgap (fBIC-MG) was measured (mm) at the mesial and distal aspects of each implant/abutment unit after 25 years of function. Values (Mean ± SE) fBIC-MG were recorded for each of the two measurement systems. ICC (Intraclass Correlation Coefficient, two-way, mixed effect model) and Bland-Altman Limits of agreement (Bland & Altman, 1986) were used to evaluate the level of agreement between the two systems

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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