Jaw, Edentulous
Conditions
Keywords
Dental Implants, Microtextured Fixture, Machined Collar
Brief 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.
Interventions
DEVICEBrånemark® 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)
DEVICEBrånemark® 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)
DEVICEBrånemark® 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
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
For the initial study, a statistician had prepared a sampling design that included three configuration diagrams. Each diagram identified five implants of the three types, and showed how one of each type was to be placed in a cyclical, side-by-side, rotating fashion at five sites between mental foramena. Allocation concealment by the project coordinator then allowed 20 participants to receive Configuration 1, 19 had Configuration 2, and 19 had Configuration 3. Configuration diagram (but not number) was stored inside each chart, and only shown to the operating team at the time of surgery. The present study is a continuation of this clinical trial, including data collected at the 25-year (24.6 ± 0.19 years, mean ± SE) follow-up. Twenty-two of the original participants (41.5%, age 71.1 ± 1.2 years, 11 women, 110 implants) were enrolled in this study. Eight participants (40 implants) received Configuration 1, 8 (40 implants) had Configuration 2, and 6 (30 implants) had Configuration 3.
Eligibility
Sex/Gender
ALL
Age
48 Years to 82 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function | 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) |
| Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function | 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) |
| Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function | 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) |
| Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function | 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) |
| Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years of Function | 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 |
Countries
Canada
Participant flow
Recruitment details
Recruitment date: May 1st - May 30th, 2019. Recruitment location: Faculty of Dental Medicine
Participants by arm
| Arm | Count |
|---|---|
| Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1) Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal), SW (Swede-Vent® dental implant unit) placed at sites 1 (left distal) and 4 (right medial), SC (Screw-Vent® dental implant unit) placed at site 3 (para symphysis) for a total of 40 dental implant units (16 B, 16 SW, 8 SC), all between mandibular foramen | 8 |
| Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1) Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal), SW (Swede-Vent® dental implant unit) placed at sites 1 (left distal) and 4 (right medial), SC (Screw-Vent® dental implant unit) placed at site 3 (para symphysis) for a total of 40 dental implant units (16 B, 16 SW, 8 SC), all between mandibular foramen | 40 |
| Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2) Device placement: B (Brånemark® dental implant unit) placed at site 3 (para symphysis), SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal), SC (Screw-Vent® dental implant unit) placed at sites 1 (left distal) and 4 (right medial) for a total of 40 dental implant units (eight B, 16 SW, 16 SC), all between mandibular foramen | 8 |
| Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2) Device placement: B (Brånemark® dental implant unit) placed at site 3 (para symphysis), SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal), SC (Screw-Vent® dental implant unit) placed at sites 1 (left distal) and 4 (right medial) for a total of 40 dental implant units (eight B, 16 SW, 16 SC), all between mandibular foramen | 40 |
| Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3) Device placement: B (Brånemark® dental implant unit) placed at sites 1 (left distal) and 4 (right medial), SW (Swede-Vent® dental implant unit) placed at site 3 (para symphysis), SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) for a total of 30 dental implant units (12 B, six SW, 12 SC), all between mandibular foramen | 6 |
| Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3) Device placement: B (Brånemark® dental implant unit) placed at sites 1 (left distal) and 4 (right medial), SW (Swede-Vent® dental implant unit) placed at site 3 (para symphysis), SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) for a total of 30 dental implant units (12 B, six SW, 12 SC), all between mandibular foramen | 30 |
| Total | 132 |
Baseline characteristics
| Characteristic | Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1) | Total | Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3) | Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2) |
|---|---|---|---|---|
| Age, Customized Age (Years): Mean ± Standard Deviation | 69.4 years STANDARD_DEVIATION 6.12 | 70.45 years STANDARD_DEVIATION 5.34 | 70.5 years STANDARD_DEVIATION 4.11 | 71.5 years STANDARD_DEVIATION 5.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 22 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 4 Participants | 3 Participants |
| Total number of implant units per study arm | 40 Number count | 110 Number count | 30 Number count | 40 Number count |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 6 |
Outcome results
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
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
Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Population: 22 participants in all Configurations contributed 110 implant units (40 Configuration 1, 40 Configuration 2, and 30 Configuration 3). One implant unit (SW, Configuration 1) had fractured, and two implant units (B and SW, Configuration 2) were excluded due to technical difficulties with radiographic technique. Consequently, 107 implant units were were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants (Configurations 1, 2, and 3) | 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 | Total 35 Brånemark® dental implant units analyzed for all three Configurations | -0.85 mm | Standard Error 0.18 |
| All Participants (Configurations 1, 2, and 3) | 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 | Total 36 Swede-Vent® dental implant units analyzed for all three Configurations | -1.00 mm | Standard Error 0.18 |
| All Participants (Configurations 1, 2, and 3) | 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 | Total 36 Screw-Vent® dental implant units analyzed for all three Configurations | -1.77 mm | Standard Error 0.18 |
Comparison: Total 35 Brånemark® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)p-value: <0.0595% CI: [-1.22, -0.49]ANOVA
Comparison: Total 36 Swede-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)p-value: <0.0595% CI: [-1.35, -0.64]ANOVA
Comparison: Total 36 Screw-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)p-value: <0.0595% CI: [-2.13, -1.41]ANOVA
Secondary
Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years 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)
Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Population: 22 participants in all Configurations contributed 110 implants (B=36, SW=38, SC=36). One implant (B Configuration 1) had fractured; two (B and SW Configuration 2) had technical issues. 107 implants were analysed after 25 years of function. Values (Mean ± SE) were calculated, recorded and compared between all B and all SW, between all B and all SC and between all SW and all SC implant units in all three Configurations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants (Configurations 1, 2, and 3) | Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function | Total 35 Brånemark® implants analyzed for all 3 Configurations | 0 Implants |
| All Participants (Configurations 1, 2, and 3) | Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function | Total 36 Swede-Vent® implants analyzed for all 3 Configurations | 0 Implants |
| All Participants (Configurations 1, 2, and 3) | Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function | Total 36 Screw-Vent® implants analyzed for all 3 Configurations. | 0 Implants |
Secondary
Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years 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)
Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Population: 22 participants in all Configurations contributed 110 units (B=36, SW=38, SC=36). 107 were analyzed (B=35. SW=36, SC=36). fBIC-MG was measured at mesial and distal sides of each unit after 25 years of function. Mean (Mean ± SE) values 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function | Total 35 Brånemark® dental implant units analyzed for all three Configurations. Plaque Mean dPI | 0.40 score on a scale | Standard Error 0.06 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function | Total 36 Swede-Vent® dental implant units analyzed for all three Configurations. Plaque Mean dPI | 0.42 score on a scale | Standard Error 0.06 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function | Total 36 Screw-Vent® dental implant units analyzed for all three Configurations. Plaque Mean dPI | 0.43 score on a scale | Standard Error 0.06 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function | Total 35 Brånemark® dental implant units analyzed for all three Configurations. Bleeding Mean dBI | 0.48 score on a scale | Standard Error 0.06 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function | Total 36 Swede-Vent dental implant units analyzed for all three Configurations. Bleeding Mean dBI | 0.47 score on a scale | Standard Error 0.05 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function | Total 36 Screw-Vent® dental implant units analyzed for all three Configurations. Bleeding Mean dBI | 0.44 score on a scale | Standard Error 0.06 |
Secondary
Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years 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)
Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Population: 22 participants in all Configurations contributed 110 units (B=36, SW=38, SC=36). 107 were analyzed (B=35. SW=36, SC=36). fBIC-MG was measured at mesial and distal sides of each unit after 25 years of function. Mean (Mean ± SE) values 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function | Total 35 Brånemark® dental implant units analyzed for all three Configurations. Purulent exudate | 0 Implants. |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function | Total 36 Swede-Vent dental implant units analyzed for all three Configurations. Purulent exudate | 1 Implants. |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function | Total 36 Screw-Vent® dental implant units analyzed for all three Configurations. Purulent exudate | 0 Implants. |
Secondary
Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years 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)
Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Population: 22 participants in all Configurations contributed 110 implants (B=36, SW=38, SC=36). One implant (B Configuration 1) had fractured; two (B and SW Configuration 2) had technical issues. 107 implants were analysed after 25 years of function. Mean (Mean ± SE) values were calculated, recorded and compared between all B and all SW, between all B and all SC and between all SW and all SC implant units in all three Configurations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function | Total 36 Screw-Vent® dental implant units analyzed for all three Configurations | 0.74 mm. | Standard Error 0.1 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function | Total 35 Brånemark® dental implant units analyzed for all three Configurations | 0.67 mm. | Standard Error 0.08 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function | Total 36 Swede-Vent® dental implant units analyzed for all three Configurations | 0.51 mm. | Standard Error 0.08 |
Secondary
Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years 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)
Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Population: 22 participants in all Configurations contributed 110 units (B=36, SW=38, SC=36). 107 were analyzed (B=35. SW=36, SC=36). fBIC-MG was measured at mesial and distal sides of each unit after 25 years of function. Mean (Mean ± SE) values 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function | Total 35 Brånemark® dental implant units analyzed for all three Configurations | 2.09 mm | Standard Error 0.14 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function | Total 36 Swede-Vent® dental implant units analyzed for all three Configurations | 2.34 mm | Standard Error 0.18 |
| All Participants (Configurations 1, 2, and 3) | Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function | Total 36 Screw-Vent® dental implant units analyzed for all three Configurations | 2.29 mm | Standard Error 0.18 |
Other Pre-specified
Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years 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
Time frame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Population: Each of the 22 participants contributed five implants for a total of 110 B=36, SW=38, SC=36) for all three configurations. However, only 95 implants (19 participants) were analyzed (B=32, SW=32, SC=31) for all three configurations in order to compare the two measurement systems. One implant (SW, Configuration 1) was fractured. Two implants (one B and one SW, both Configuration 2) had technical issues with radiographs. Twelve implants could not be measured due to participant refusal
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants (Configurations 1, 2, and 3) | Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years of Function | ICC (Intraclass Correlation Coefficient two-way, mixed effect model) | 0.93 Implants |
| All Participants (Configurations 1, 2, and 3) | Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years of Function | Bland-Altman Limits of agreement (Bland & Altman,1986) | 0.15 Implants |