Trial Outcomes & Findings for Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours (NCT NCT00711022)

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

51 participants

Primary outcome timeframe

At 5-year follow-up

Results posted on

2014-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	OsseoSpeed ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Overall Study STARTED	51
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsseoSpeed n=51 Participants ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Age, Continuous	65.8 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 5-year follow-up

Population: Per protocol analysis presented, this includes implants loaded within 24 hours from implant placement (306 implants in 51 subjects), of these 20 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=306 Implants ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Implant Survival Rate	93.10 percentage of implants

Adverse Events

OsseoSpeed

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OsseoSpeed n=51 participants at risk ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Gastrointestinal disorders Obstructed small intestine	2.0% 1/51
Vascular disorders Stroke	2.0% 1/51
Vascular disorders Cerebral vascular accident	2.0% 1/51
Gastrointestinal disorders Rectal issue	2.0% 1/51
General disorders Drug related reaction	2.0% 1/51

Other adverse events

Adverse event data not reported

Additional Information

Senior Manager Global Clinical Research

DENTSPLY Implants

Phone: +46313763500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60