Trial Outcomes & Findings for A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases (NCT NCT00723944)

Last Updated: 2022-04-19

Results Overview

Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.

Recruitment status

COMPLETED

Study phase

Target enrollment

102 participants

Primary outcome timeframe

1 year

Results posted on

2022-04-19

Participant Flow

A minimum of 100 patients were enrolled across all participating centers, with enrollment beginning in January 2005. Enrollment period remained open until April 2006. Three participating sites were Universities and seven were private practices.

Pre-treatment included a screening visit (enroll those meeting all inclusion criteria), signing informed consent, and pre-surgical data collection.Patients returned for implant placement surgery, followed by temporary prosthesis placement at 2 months.

Participant milestones

Participant milestones
Measure	Osseotite Certain Prevail Implant Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
Implant Placement Surgery STARTED	52	50
Implant Placement Surgery COMPLETED	52	50
Implant Placement Surgery NOT COMPLETED	0	0
Permanent Prosthesis Placement STARTED	52	50
Permanent Prosthesis Placement COMPLETED	49	41
Permanent Prosthesis Placement NOT COMPLETED	3	9
One Year Post Placement Follow-up STARTED	49	41
One Year Post Placement Follow-up COMPLETED	48	37
One Year Post Placement Follow-up NOT COMPLETED	1	4
Two Year Post Placement Follow-up STARTED	48	37
Two Year Post Placement Follow-up COMPLETED	48	37
Two Year Post Placement Follow-up NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Osseotite Certain Prevail Implant Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
Permanent Prosthesis Placement Adverse Event	1	7
Permanent Prosthesis Placement Lost to Follow-up	2	2
One Year Post Placement Follow-up Lost to Follow-up	1	4

Baseline Characteristics

A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Osseotite Certain Prevail Implant n=52 Participants Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant n=50 Participants Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Italy	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants
Region of Enrollment France	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Germany	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Sweden	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: population represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.

Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.

Outcome measures

Outcome measures
Measure	Osseotite Certain Prevail Implant n=130 implants Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant n=108 implants Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit	-0.7705 millimeters Standard Error 0.1567	-0.6648 millimeters Standard Error .1158

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

Adverse Events

Osseotite Certain Prevail Implant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Osseotite Certain Implant

Serious events: 0 serious events

Other events: 19 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=52 participants at risk Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant n=50 participants at risk Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
Surgical and medical procedures Loss of implant integration	7.7% 4/52 • Number of events 4 • Adverse event reporting is collected from day of the study to present, currently 4 years study duration. Adverse event data is collected by patient questionaire and visual inspection (assessment) of patient's mouth during each study event visit.	38.0% 19/50 • Number of events 19 • Adverse event reporting is collected from day of the study to present, currently 4 years study duration. Adverse event data is collected by patient questionaire and visual inspection (assessment) of patient's mouth during each study event visit.

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