Trial Outcomes & Findings for A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading. (NCT NCT00728962)

Last Updated: 2022-04-19

Results Overview

Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.

Recruitment status

COMPLETED

Target enrollment

75 participants

Primary outcome timeframe

1 year

Results posted on

2022-04-19

Participant Flow

Each site endeavored to enroll a maximum of 15 patients, with enrollment efforts beginning in March 2005. Enrollment period remained open at all sites until April 2006. Three participating sites are Universities and four are private practices.

Pre-treatment included a screening visit(enroll those meeting all study inclusion criteria), signing informed consent, and pre-surgical data collection. Within 48hrs., impressions of the patient's treatment areas are taken for making a temporary prosthesis. Patients are then scheduled for implant placement surgery.

Participant milestones

Participant milestones
Measure	Osseotite Certain Prevail Implant Internal connection implant with an expanded platform and lateralization with a tapered apex
Implant Placement Surgery STARTED	75
Implant Placement Surgery COMPLETED	65
Implant Placement Surgery NOT COMPLETED	10
Permanent Prosthesis Placement STARTED	65
Permanent Prosthesis Placement COMPLETED	62
Permanent Prosthesis Placement NOT COMPLETED	3
One Year Post Placement Follow-up STARTED	62
One Year Post Placement Follow-up COMPLETED	62
One Year Post Placement Follow-up NOT COMPLETED	0
Two Year Post Placement Follow-up STARTED	62
Two Year Post Placement Follow-up COMPLETED	59
Two Year Post Placement Follow-up NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Osseotite Certain Prevail Implant Internal connection implant with an expanded platform and lateralization with a tapered apex
Implant Placement Surgery Adverse Event	8
Implant Placement Surgery Lost to Follow-up	1
Implant Placement Surgery Protocol Violation	1
Permanent Prosthesis Placement Adverse Event	3
Two Year Post Placement Follow-up Lost to Follow-up	3

Baseline Characteristics

A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Osseotite Certain Prevail Implant n=75 Participants Internal connection implant with an expanded platform and lateralization with a tapered apex
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
Region of Enrollment Italy	17 participants n=5 Participants
Region of Enrollment Netherlands	7 participants n=5 Participants
Region of Enrollment France	16 participants n=5 Participants
Region of Enrollment Germany	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: total number of patients enrolled in the study was used for primary outcome analysis

Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.

Outcome measures

Outcome measures
Measure	Osseotite Certain Prevail Implant n=75 Participants Internal connection implant with an expanded platform and lateralization with a tapered apex
Patients With Implants Achieving Osseous Integration	59 participants

SECONDARY outcome

Timeframe: four years

Outcome measures

Outcome data not reported

Adverse Events

Osseotite Certain Prevail Implant

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Osseotite Certain Prevail Implant n=75 participants at risk Internal connection implant with an expanded platform and lateralization with a tapered apex
Surgical and medical procedures Loss of integration of implant	14.7% 11/75 • Number of events 11 • Adverse event reports are collected from day 1 to present; 4 years of study duration to date. Adverse event data is collected during each study event visit the patient is seen for.

Additional Information

Clinical Research Manager

Biomet 3i LLC

Phone: 5617766722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI shall furnish SPONSOR with a copy of any proposed publication thirty (30) days prior to submission for publication for review and comment. SPONSOR may request PI to delay publishing such proposed publication for a maximum of an additional sixty (60) days in order to protect the potential patentability of any invention described therein.
Publication restrictions are in place

Restriction type: OTHER