Trial Outcomes & Findings for An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration. (NCT NCT01641198)

Last Updated: 2020-12-17

Results Overview

Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest was measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded after 12 months of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3

Recruitment status

COMPLETED

Study phase

Target enrollment

58 participants

Primary outcome timeframe

After 12 months of function

Results posted on

2020-12-17

Participant Flow

Recruitment period: 1990 - 1992

Sixty participants were recruited; however, two participants opted out prior to informed consent and random assignment to an arm.

Unit of analysis: Implants

Participant milestones

Participant milestones
Measure	Configuration 1 Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3	Configuration 2 Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4	Configuration 3 Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
After 12 Months of Function STARTED	20 100	19 95	19 95
After 12 Months of Function COMPLETED	16 67	16 77	17 82
After 12 Months of Function NOT COMPLETED	4 33	3 18	2 13
After 24 Months of Function STARTED	16 67	16 77	17 82
After 24 Months of Function COMPLETED	12 57	7 35	11 53
After 24 Months of Function NOT COMPLETED	4 10	9 42	6 29
At 15-20 Years of Function STARTED	12 57	7 35	11 53
At 15-20 Years of Function COMPLETED	6 30	6 30	9 45
At 15-20 Years of Function NOT COMPLETED	6 27	1 5	2 8

Reasons for withdrawal

Reasons for withdrawal
Measure	Configuration 1 Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3	Configuration 2 Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4	Configuration 3 Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
After 12 Months of Function Lost to Follow-up	3	2	2
After 12 Months of Function Protocol Violation	1	0	0
After 12 Months of Function Adverse Event	0	1	0
After 24 Months of Function Lost to Follow-up	4	9	6
At 15-20 Years of Function Lost to Follow-up	5	1	1
At 15-20 Years of Function Death	1	0	1

Baseline Characteristics

An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Configuration 1 n=100 Implants Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3	Configuration 2 n=95 Implants Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4	Configuration 3 n=95 Implants Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5	Total n=290 Implants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 5.3 • n=5 Participants	45.5 years STANDARD_DEVIATION 5.6 • n=7 Participants	44.8 years STANDARD_DEVIATION 6.1 • n=5 Participants	45.2 years STANDARD_DEVIATION 5.6 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Region of Enrollment Canada	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Number of Participants with Health Status ASA Classification 1	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Number of Participants with Mandibular bone classification types 2 & 3	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Removable complete dental prostheses obligatory	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Specifically requesting a complete lower prosthesis on implants	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Accepting to sign informed consent documents	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants

PRIMARY outcome

Timeframe: After 12 months of function

Population: Reasons for decrease in population number: 7 did non-respect interval follow up protocol, 1 adverse event, 1 protocol violation. Reasons for decrease in number of units (implants): radiographs did not allow precise location of first bone-to-implant contact point (fBIC) and microgap (MG) due to technical reasons for 19 implants

Outcome measures

Outcome measures
Measure	Configuration 1 n=67 Implants. Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3	Configuration 2 n=77 Implants. Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4	Configuration 3 n=82 Implants. Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
Comparison of Quantitative Bone Healing	-1.18 mm Standard Error 0.15	-1.01 mm Standard Error 0.16	-0.91 mm Standard Error 0.17

PRIMARY outcome

Timeframe: After 24 months of function

Population: Reasons for decrease in the number of participants: 19 did not respect follow up interval. Reasons for decrease in number of units (implants): radiographs did not allow precise location of first bone-to-implant contact point (fBIC) and microgap (MG) due to technical reasons for 5 implants

Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded after 24 months of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3

Outcome measures

Outcome measures
Measure	Configuration 1 n=57 implants Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3	Configuration 2 n=35 implants Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4	Configuration 3 n=53 implants Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
Comparison of Quantitative Bone Healing	-1.16 mm Standard Error 0.18	-0.87 mm Standard Error 0.23	-1.33 mm Standard Error 0.18

PRIMARY outcome

Timeframe: At 15-20 years of function

Population: Reasons for decrease in the number of participants: 7 did not respect follow up interval, 2 unrelated deaths

Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded at 15 to 20 years of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3

Outcome measures

Outcome measures
Measure	Configuration 1 n=30 implants Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3	Configuration 2 n=30 implants Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4	Configuration 3 n=45 implants Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
Comparison of Quantitative Bone Healing	-1.32 mm Standard Error 0.27	-1.42 mm Standard Error 0.33	-1.54 mm Standard Error 0.33

Adverse Events

Configuration 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Configuration 2

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Configuration 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Configuration 1 n=20 participants at risk Surgical placement of devices (implants): B at sites 2 and 5, SW at sites 1 and 4, SC at site 3	Configuration 2 n=19 participants at risk Surgical placement of devices (implants): B at site 3, SW at sites 2 and 5, SC at sites 1 and 4	Configuration 3 n=19 participants at risk Surgical placement of devices (implants): B at sites 1 and 4, SW at site 3, SC at sites 2 and 5
Musculoskeletal and connective tissue disorders Loss of jaw implant	0.00% 0/20 • Adverse data collection after 12 and 24 months, and 15-20 years of function	5.3% 1/19 • Number of events 1 • Adverse data collection after 12 and 24 months, and 15-20 years of function	0.00% 0/19 • Adverse data collection after 12 and 24 months, and 15-20 years of function

Other adverse events

Adverse event data not reported

Additional Information

Dr. Aldo-Joseph Camarda

Université de Montréal

Phone: (514) 343-7124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place