Trial Outcomes & Findings for Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later (NCT NCT00711113)

Results Overview

An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

At 5 year follow-up

Results posted on

2014-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	OsseoSpeed Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Overall Study STARTED	47
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	OsseoSpeed Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Overall Study Lost to Follow-up	9
Overall Study Implant lost	2

Baseline Characteristics

Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsseoSpeed n=32 Participants Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Age, Continuous	59 years STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	19 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Region of Enrollment United States	30 participants n=99 Participants
Region of Enrollment Germany	2 participants n=99 Participants

PRIMARY outcome

Timeframe: At 5 year follow-up

Population: Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.

An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.

Outcome measures

Outcome measures
Measure	OsseoSpeed n=80 Implants Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Implant Survival Rate	96.25 percentage of implants

PRIMARY outcome

Timeframe: At 1 year follow-up

Population: Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.

Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (\<60) indicate low stability, medium values (60-70) indicate medium stability and high values (\>70) indicate high stability.

Outcome measures

Outcome measures
Measure	OsseoSpeed n=80 Implants Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Implant Stability	68.3 units on a scale Standard Deviation 6.7

PRIMARY outcome

Timeframe: At baseline (loading) and at 5 year follow-up

Population: Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.

Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.

Outcome measures

Outcome measures
Measure	OsseoSpeed n=68 Implants Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Marginal Bone Adaptation	0.3 Millimeter Standard Deviation 0.9

Adverse Events

OsseoSpeed

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OsseoSpeed n=47 participants at risk Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Cardiac disorders Heart attack	2.1% 1/47 • Number of events 2
Vascular disorders Subdural hematoma	2.1% 1/47 • Number of events 1
Vascular disorders Blod clot in lower leg	2.1% 1/47 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Manager Global Clinical Operations

DENTSPLY Implants

Phone: +46313763500

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60