Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1) Device placement: B (Brånemark® dental implant) placed at two sites, SW (Swede-Vent® dental implant) placed at two sites, SC (Screw-Vent® dental implant) placed at one site |
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)
|
| Experimental: Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2) Device placement: B (Brånemark® dental implant) placed at one site, SW (Swede-Vent® dental implant) placed at two sites, SC (Screw-Vent® dental implant) placed at two sites |
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)
|
| Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3) Device placement: B (Brånemark® dental implant) placed at two sites, SW (Swede-Vent® dental implant) placed at one site, SC (Screw-Vent® dental implant) placed at two sites |
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)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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: 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)
- 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)
Other Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Université de Montréal | Montreal | Quebec | Canada | H3C 3J7 |
Sponsors and Collaborators
- Université de Montréal
Investigators
- Principal Investigator: Aldo J Camarda, DDS, MSc, Université de Montréal
- Principal Investigator: Robert Durand, DMD, MSc, Université de Montréal
- Principal Investigator: Marwa Benkarim, Université de Montréal
- Principal Investigator: Pierre Rompré, MSc, Université de Montréal
- Principal Investigator: Geneviève Guertin, DMD, MSc, Université de Montréal
- Study Director: Hugo Ciaburro, DMD, MSc, Université de Montréal
Study Documents (Full-Text)
More Information
Publications
- Adell, R. (1987). Long-term treatment results. In: Brånemark, P-I., Zarb, G.A., Albrektsson, T. (Eds.). Tissue-integrated prostheses: osseointegration in clinical dentistry (pp. 175-285). Quintessence Publishing Co. Inc.
- Albrektsson T, Brånemark PI, Hansson HA, Lindström J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70.
- Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. Review.
- Bhaskaran V, Qualtrough AJ, Rushton VE, Worthington HV, Horner K. A laboratory comparison of three imaging systems for image quality and radiation exposure characteristics. Int Endod J. 2005 Sep;38(9):645-52.
- Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Brånemark P-I. (1987). Introduction to osseointegration. In Brånemark, P-I., Zarb, G.A., Albrektsson, T. (Eds.). Tissue-integrated prostheses: osseointegration in clinical dentistry (pp. 11-76). Quintessence Publishing Co. Inc.
- Brånemark PI. Osseointegration and its experimental background. J Prosthet Dent. 1983 Sep;50(3):399-410. Review.
- De Bruyn H, Collaert B, Lindén U, Flygare L. A comparative study of the clinical efficacy of Screw Vent implants versus Brånemark fixtures, installed in a periodontal clinic. Clin Oral Implants Res. 1992 Mar;3(1):32-41.
- Galgut P. A comparison of different indices used in the clinical assessment of plaque and gingival bleeding. Clin Oral Investig. 1999 Jun;3(2):96-9.
- Niznick, G. A. (1989). Open letters no. 1 and no. 2 to the dental profession, Core-Vent Corporation Newsletter and manufacturer's product description. Encino, California USA.
- CERC-19-015-P
Study Results
Participant Flow
| Recruitment Details | Recruitment date: May 1st - May 30th, 2019. Recruitment location: Faculty of Dental Medicine |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Active Comparator: Brånemark® (B) 2, Swede-Vent® (SW) 2, Screw-Vent® (SC) 1 (Configuration 1) | Experimental: Brånemark® (B) 1, Swede-Vent® (SW) 2, Screw-Vent® (SC) 2 (Configuration 2) | Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3) |
|---|---|---|---|
| Arm/Group Description | 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) between mandibular foramen | 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) between mandibular foramen | 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) between mandibular foramen |
| Period Title: Overall Study | |||
| STARTED | 8 | 8 | 6 |
| COMPLETED | 8 | 8 | 6 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1) | Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2) | Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3) | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | Total of all reporting groups |
| Overall Participants | 8 | 8 | 6 | 22 |
| Overall Implants | 40 | 40 | 30 | 110 |
| Age, Customized (years) [Mean (Standard Deviation) ] | ||||
| Age (Years): Mean ± Standard Deviation |
69.4
(6.12)
|
71.5
(5.09)
|
70.5
(4.11)
|
70.45
(5.34)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
4
50%
|
5
62.5%
|
2
33.3%
|
11
50%
|
| Male |
4
50%
|
3
37.5%
|
4
66.7%
|
11
50%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
8
100%
|
8
100%
|
6
100%
|
22
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Total number of implant units per study arm (Number count) [Number] | ||||
| Number [Number count] |
40
|
40
|
30
|
110
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Participants (Configurations 1, 2, and 3) |
|---|---|
| Arm/Group Description | Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) |
| Measure Participants | 22 |
| Measure Implants | 107 |
| Total 35 Brånemark® dental implant units analyzed for all three Configurations |
-0.85
(0.18)
|
| Total 36 Swede-Vent® dental implant units analyzed for all three Configurations |
-1.00
(0.18)
|
| Total 36 Screw-Vent® dental implant units analyzed for all three Configurations |
-1.77
(0.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | All Participants (Configurations 1, 2, and 3) |
|---|---|---|
| Comments | 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) | |
| Type of Statistical Test | Equivalence | |
| Comments | Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | Bonferroni correction was applied for pairwise comparisons | |
| Method | ANOVA | |
| Comments | Repeated measures ANOVA. Dahlberg measurement error | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.85 | |
| Confidence Interval |
(2-Sided) 95% -1.22 to -0.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | All Participants (Configurations 1, 2, and 3) |
|---|---|---|
| Comments | 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) | |
| Type of Statistical Test | Equivalence | |
| Comments | Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | Bonferroni correction was applied for pairwise comparisons | |
| Method | ANOVA | |
| Comments | Repeated measures ANOVA. Dahlberg measurement error | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.00 | |
| Confidence Interval |
(2-Sided) 95% -1.35 to -0.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | All Participants (Configurations 1, 2, and 3) |
|---|---|---|
| Comments | 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) | |
| Type of Statistical Test | Equivalence | |
| Comments | Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | Bonferroni correction was applied for pairwise comparisons | |
| Method | ANOVA | |
| Comments | Repeated measures ANOVA. Dahlberg measurement error | |
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -1.77 | |
| Confidence Interval |
(2-Sided) 95% -2.13 to -1.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
| Title | Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Participants (Configurations 1, 2, and 3) |
|---|---|
| Arm/Group Description | Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) |
| Measure Participants | 22 |
| Measure Implants | 107 |
| Total 35 Brånemark® implants analyzed for all 3 Configurations |
0
|
| Total 36 Swede-Vent® implants analyzed for all 3 Configurations |
0
|
| Total 36 Screw-Vent® implants analyzed for all 3 Configurations. |
0
|
| Title | Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Participants (Configurations 1, 2, and 3) |
|---|---|
| Arm/Group Description | Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) |
| Measure Participants | 22 |
| Measure Implants | 107 |
| Total 35 Brånemark® dental implant units analyzed for all three Configurations |
0.67
(0.08)
|
| Total 36 Swede-Vent® dental implant units analyzed for all three Configurations |
0.51
(0.08)
|
| Total 36 Screw-Vent® dental implant units analyzed for all three Configurations |
0.74
(0.10)
|
| Title | Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Participants (Configurations 1, 2, and 3) |
|---|---|
| Arm/Group Description | Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) |
| Measure Participants | 22 |
| Measure Implants | 107 |
| Total 35 Brånemark® dental implant units analyzed for all three Configurations |
2.09
(0.14)
|
| Total 36 Swede-Vent® dental implant units analyzed for all three Configurations |
2.34
(0.18)
|
| Total 36 Screw-Vent® dental implant units analyzed for all three Configurations |
2.29
(0.18)
|
| Title | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Participants (Configurations 1, 2, and 3) |
|---|---|
| Arm/Group Description | Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) |
| Measure Participants | 22 |
| Measure Implants | 107 |
| Total 35 Brånemark® dental implant units analyzed for all three Configurations. Plaque Mean dPI |
0.40
(0.06)
|
| Total 36 Swede-Vent® dental implant units analyzed for all three Configurations. Plaque Mean dPI |
0.42
(0.06)
|
| Total 36 Screw-Vent® dental implant units analyzed for all three Configurations. Plaque Mean dPI |
0.43
(0.06)
|
| Total 35 Brånemark® dental implant units analyzed for all three Configurations. Bleeding Mean dBI |
0.48
(0.06)
|
| Total 36 Swede-Vent dental implant units analyzed for all three Configurations. Bleeding Mean dBI |
0.47
(0.05)
|
| Total 36 Screw-Vent® dental implant units analyzed for all three Configurations. Bleeding Mean dBI |
0.44
(0.06)
|
| Title | Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Participants (Configurations 1, 2, and 3) |
|---|---|
| Arm/Group Description | Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) |
| Measure Participants | 22 |
| Measure Implants. | 107 |
| Total 35 Brånemark® dental implant units analyzed for all three Configurations. Purulent exudate |
0
|
| Total 36 Swede-Vent dental implant units analyzed for all three Configurations. Purulent exudate |
1
|
| Total 36 Screw-Vent® dental implant units analyzed for all three Configurations. Purulent exudate |
0
|
| Title | Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years of Function |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Participants (Configurations 1, 2, and 3) |
|---|---|
| Arm/Group Description | Configuration 1: Device placement: B (Brånemark® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 2: Device placement SW (Swede-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) Configuration 3: Device placement SC (Screw-Vent® dental implant unit) placed at sites 2 (left medial) and 5 (right distal) |
| Measure Participants | 22 |
| Measure Implants | 95 |
| ICC (Intraclass Correlation Coefficient two-way, mixed effect model) |
0.93
|
| Bland-Altman Limits of agreement (Bland & Altman,1986) |
0.15
|
Adverse Events
| Time Frame | After 25 years (24.6 ± 0.19 years, mean ± SE) of function. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All B,SW, and SC units (implants) surgically placed in participants' jaws, and restored with prostheses, at start of original project (ClinicalTrials.gov ID No. NCT01641198) 25 years previously have no possible adverse effects on the overall health of participants. B, SW, and SC implants were and remain FDA and Health and Welfare Canada approved, and have been and continue to be sold to this day internationally, with the exception of SW (Swede-Vent®) that has been discontinued. | |||||
| Arm/Group Title | Active Comparator: Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1). | Experimental: Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2). | Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3). | |||
| Arm/Group Description | 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). | 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 O(left distal) and 4 (right medial). | 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). | |||
All Cause Mortality |
||||||
| Active Comparator: Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1). | Experimental: Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2). | Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3). | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/6 (0%) | |||
Serious Adverse Events |
||||||
| Active Comparator: Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1). | Experimental: Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2). | Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3). | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/6 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Active Comparator: Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1). | Experimental: Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2). | Experimental: Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3). | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/6 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Aldo Joseph Camarda |
|---|---|
| Organization | Université de Montréal |
| Phone | 514-343-7124 |
| aj.camarda@umontreal.ca |
- CERC-19-015-P