Trial Outcomes & Findings for Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible (NCT NCT00728884)

NCT ID: NCT00728884

Last Updated: 2024-01-30

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 162 participants
• Primary outcome timeframe: one year
• Results posted on: 2024-01-30

Participant Flow

Up to 200 patients will be enrolled across all participating centers, with enrollment efforts beginning in August 2005. Enrollment period remained until February 2007. Ten participating sites are private practices and two are Universities.

Pre-treatment included a screening visit (enroll those meeting all inclusion criteria),signing informed consent, and per-surgical data collection. Patients are then scheduled for implant placement surgery.

Participant milestones

Measure	Certain Prevail Implants Osseotite surfaced implants with internal connection
Implant Placement Surgery STARTED	162
Implant Placement Surgery COMPLETED	162
Implant Placement Surgery NOT COMPLETED	0
Permanent Prosthesis Placement STARTED	162
Permanent Prosthesis Placement COMPLETED	149
Permanent Prosthesis Placement NOT COMPLETED	13
One Year Post Placement Follow-up STARTED	149
One Year Post Placement Follow-up COMPLETED	145
One Year Post Placement Follow-up NOT COMPLETED	4
Two Year Post Placement Follow-up STARTED	145
Two Year Post Placement Follow-up COMPLETED	145
Two Year Post Placement Follow-up NOT COMPLETED	0

Reasons for withdrawal

Measure	Certain Prevail Implants Osseotite surfaced implants with internal connection
Permanent Prosthesis Placement Lost to Follow-up	13
One Year Post Placement Follow-up Lost to Follow-up	4

Baseline Characteristics

Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible

Baseline characteristics by cohort

Measure	Certain Prevail Implants n=162 Participants Osseotite surfaced implants with internal connection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	135 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Region of Enrollment Austria	26 participants n=5 Participants
Region of Enrollment Australia	10 participants n=5 Participants
Region of Enrollment Ireland	14 participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Region of Enrollment Italy	52 participants n=5 Participants
Region of Enrollment France	9 participants n=5 Participants
Region of Enrollment Sweden	20 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.

Outcome measures

Measure	Certain Prevail Implants n=162 Participants Osseotite surfaced implants with internal connection
Osseous Integration	145 participants

SECONDARY outcome

Timeframe: four years

Crestal bone level measures- changes from baseline to last study visit

Outcome measures

Outcome data not reported

Adverse Events

Certain Prevail Implants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Manager

Biomet 3i LLC

Phone: 5617766722

Email: cristina.matthews@biomet.com

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