Trial Outcomes & Findings for Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later (NCT NCT00711425)

Last Updated: 2013-09-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

At 5 year follow-up

Results posted on

2013-09-09

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	45
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	4

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 Protocol Violation	1
Overall Study Death	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsseoSpeed n=44 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	57 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	22 Participants n=93 Participants
Sex: Female, Male Male	22 Participants n=93 Participants
Region of Enrollment United States	29 participants n=93 Participants
Region of Enrollment Germany	15 participants n=93 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 (134 implants in 44 patients).

Outcome measures

Outcome measures
Measure	OsseoSpeed n=134 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	100 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 (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.

Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.

Outcome measures

Outcome measures
Measure	OsseoSpeed n=130 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	77.4 ISQ Standard Deviation 7.1

PRIMARY outcome

Timeframe: At 5 year follow-up

Population: Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.

Marginal bone adaptation will be 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 will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.

Outcome measures

Outcome measures
Measure	OsseoSpeed n=123 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	-0.05 Millimeter Standard Deviation 1.96

Adverse Events

OsseoSpeed

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OsseoSpeed n=45 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.
Renal and urinary disorders KIDNEY ABCESS	2.2% 1/45 • Number of events 1
Musculoskeletal and connective tissue disorders LOWER LUMBAR PAIN	2.2% 1/45 • Number of events 1
Vascular disorders AORTIC ANEURYSM	2.2% 1/45 • Number of events 1
Musculoskeletal and connective tissue disorders SHOULDER PAIN	2.2% 1/45 • Number of events 1
Cardiac disorders HEART ATTACK	4.4% 2/45 • Number of events 2
Gastrointestinal disorders INTESTINAL PAIN	2.2% 1/45 • Number of events 1
Investigations PT HAD MRI, CT SCAN + COLON OSCOPY DUE TO PAIN ON R ABDOMEN	2.2% 1/45 • Number of events 1
Respiratory, thoracic and mediastinal disorders BACTERIAL LUNG INFECTION LED TO COLLAPSED LUNG	2.2% 1/45 • Number of events 1
Surgical and medical procedures FLUID MASS REMOVED FROM LUNG AFTER INFECTION CLEARED	2.2% 1/45 • Number of events 1
Surgical and medical procedures HYSTERECTOMY	2.2% 1/45 • Number of events 1
Surgical and medical procedures HEART SURGERY (4 BYPASSES)	2.2% 1/45 • Number of events 1
Infections and infestations TOXAEMIA AT RIGHT FOOT	2.2% 1/45 • Number of events 1
Surgical and medical procedures INJECTIONS BECAUSE OF PAIN IN THE LUMBAR SPINE	2.2% 1/45 • Number of events 1
Surgical and medical procedures OPERATION, SECOND STENT	2.2% 1/45 • Number of events 1
Surgical and medical procedures CLEANSING OF FRONTAL SINUS	2.2% 1/45 • Number of events 1
Surgical and medical procedures CYSTECTOMIA, ABLATION OF WISDOM TEETH	2.2% 1/45 • 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