Trial Outcomes & Findings for Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function (NCT NCT03862482)
NCT ID: NCT03862482
Last Updated: 2021-06-14
Results Overview
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
COMPLETED
NA
22 participants
After 25 years (24.6 ± 0.19 years, mean ± SE) of function
2021-06-14
Participant Flow
Recruitment date: May 1st - May 30th, 2019. Recruitment location: Faculty of Dental Medicine
Unit of analysis: Implants
Participant milestones
| Measure |
Active Comparator: Brånemark® (B) 2, Swede-Vent® (SW) 2, Screw-Vent® (SC) 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) between mandibular foramen
|
Experimental: Brånemark® (B) 1, Swede-Vent® (SW) 2, Screw-Vent® (SC) 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) between mandibular foramen
|
Experimental: 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) between mandibular foramen
|
|---|---|---|---|
|
Overall Study
STARTED
|
8 40
|
8 40
|
6 30
|
|
Overall Study
COMPLETED
|
8 39
|
8 38
|
6 30
|
|
Overall Study
NOT COMPLETED
|
0 1
|
0 2
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function
Baseline characteristics by cohort
| Measure |
Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)
n=40 Implants
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
|
Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)
n=40 Implants
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
|
Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)
n=30 Implants
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
n=110 Implants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age (Years): Mean ± Standard Deviation
|
69.4 years
STANDARD_DEVIATION 6.12 • n=5 Participants
|
71.5 years
STANDARD_DEVIATION 5.09 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 4.11 • n=5 Participants
|
70.45 years
STANDARD_DEVIATION 5.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Total number of implant units per study arm
|
40 Number count
n=63 Implants
|
40 Number count
n=85 Implants
|
30 Number count
n=148 Implants
|
110 Number count
n=110 Implants
|
PRIMARY outcome
Timeframe: After 25 years (24.6 ± 0.19 years, mean ± SE) of functionPopulation: 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.
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
Outcome measures
| Measure |
All Participants (Configurations 1, 2, and 3)
n=107 Implants
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)
|
|---|---|
|
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 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
|
|
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
|
SECONDARY outcome
Timeframe: After 25 years (24.6 ± 0.19 years, mean ± SE) of functionPopulation: 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
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)
Outcome measures
| Measure |
All Participants (Configurations 1, 2, and 3)
n=107 Implants
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)
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: After 25 years (24.6 ± 0.19 years, mean ± SE) of functionPopulation: 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
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)
Outcome measures
| Measure |
All Participants (Configurations 1, 2, and 3)
n=107 Implants
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)
|
|---|---|
|
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
|
|
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
|
|
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 0.10
|
SECONDARY outcome
Timeframe: After 25 years (24.6 ± 0.19 years, mean ± SE) of functionPopulation: 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
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)
Outcome measures
| Measure |
All Participants (Configurations 1, 2, and 3)
n=107 Implants
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)
|
|---|---|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: After 25 years (24.6 ± 0.19 years, mean ± SE) of functionPopulation: 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
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)
Outcome measures
| Measure |
All Participants (Configurations 1, 2, and 3)
n=107 Implants
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)
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: After 25 years (24.6 ± 0.19 years, mean ± SE) of functionPopulation: 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
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)
Outcome measures
| Measure |
All Participants (Configurations 1, 2, and 3)
n=107 Implants.
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)
|
|---|---|
|
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.
|
|
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.
|
|
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.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 25 years (24.6 ± 0.19 years, mean ± SE) of functionPopulation: 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
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
Outcome measures
| Measure |
All Participants (Configurations 1, 2, and 3)
n=95 Implants
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)
|
|---|---|
|
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
Interval -1.21 to 1.51
|
|
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
Interval 0.89 to 0.95
|
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).
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place