Trial Outcomes & Findings for Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw (NCT NCT00646113)

Last Updated: 2019-11-18

Results Overview

Overall implant survival rate evaluated clinically and radiographically

Recruitment status

COMPLETED

Study phase

Target enrollment

72 participants

Primary outcome timeframe

Evaluated at implant placement and at the 5 years follow-up after implant placement

Results posted on

2019-11-18

Unit of analysis: Implants

Participant milestones
Measure	OsseoSpeed™ TX 3.0 OsseoSpeed™ TX 3.0 mm diameter implants (lengths 11 mm, 13 mm and 15 mm).
Overall Study STARTED	69 97
Overall Study COMPLETED	61 86
Overall Study NOT COMPLETED	8 11

Reasons for withdrawal
Measure	OsseoSpeed™ TX 3.0 OsseoSpeed™ TX 3.0 mm diameter implants (lengths 11 mm, 13 mm and 15 mm).
Overall Study Lost to Follow-up	5
Overall Study Adverse Event	3

Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw

Baseline characteristics by cohort
Measure	OsseoSpeed™ TX 3.0S n=97 Implants OsseoSpeed™ TX 3.0 mm diameter
Age, Continuous	32.5 years STANDARD_DEVIATION 15.11 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment Sweden	15 participants n=5 Participants
Region of Enrollment Denmark	14 participants n=5 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants
Region of Enrollment Italy	10 participants n=5 Participants
Region of Enrollment Germany	4 participants n=5 Participants
Region of Enrollment Spain	14 participants n=5 Participants

Timeframe: Evaluated at implant placement and at the 5 years follow-up after implant placement

Population: A total of 69 subjects were enrolled in the study and received a total of 97 implants.

Overall implant survival rate evaluated clinically and radiographically

Outcome measures
Measure	OsseoSpeed™ n=97 Implants OsseoSpeed™ TX 3.0 mm diameter
Implant Survival Rate	93 Implants

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	OsseoSpeed™ TX 3.0S n=69 participants at risk OsseoSpeed™ TX 3.0 mm diameter
Product Issues Crown loss	14.5% 10/69 • Number of events 10 • 5 years
Product Issues Abutment fractures	10.1% 7/69 • Number of events 7 • 5 years
Product Issues Implant lost	5.8% 4/69 • Number of events 4 • 5 years
Infections and infestations Common cold	20.3% 14/69 • Number of events 30 • 5 years
General disorders Headache	5.8% 4/69 • Number of events 8 • 5 years

Dentsply Sirona Implants, Mölndal, SWEDEN

Phone: 0046313763500

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