Trial Outcomes & Findings for A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases. (NCT NCT00728754)

Last Updated: 2024-08-20

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

61 participants

Primary outcome timeframe

1 year

Results posted on

2024-08-20

Participant Flow

Up to 120 patients were enrolled across all centers, with enrollment efforts beginning in February 2005. Enrollment period remained open until June 2006. Two participating sites were Universities and four 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 lateralized expanded platform design
Implant Placement Surgery STARTED	29	32
Implant Placement Surgery COMPLETED	29	32
Implant Placement Surgery NOT COMPLETED	0	0
Permanent Prosthesis Placement STARTED	29	32
Permanent Prosthesis Placement COMPLETED	25	28
Permanent Prosthesis Placement NOT COMPLETED	4	4
One Year Post Placement Follow-up STARTED	25	28
One Year Post Placement Follow-up COMPLETED	24	28
One Year Post Placement Follow-up NOT COMPLETED	1	0
Two Year Post Placement Follow-up STARTED	24	28
Two Year Post Placement Follow-up COMPLETED	24	28
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 lateralized expanded platform design
Permanent Prosthesis Placement Adverse Event	1	1
Permanent Prosthesis Placement Lost to Follow-up	3	3
One Year Post Placement Follow-up Adverse Event	1	0

Baseline Characteristics

A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Osseotite Certain Prevail Implant n=29 Participants Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant n=32 Participants Patients with dental implant with internal connection and without the lateralized expanded platform design	Total n=61 Participants Total of all reporting groups
Age, Customized <=18 years	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Age, Customized Between 18 and 65 years	18 participants n=99 Participants	21 participants n=107 Participants	39 participants n=206 Participants
Age, Customized >=65 years	11 participants n=99 Participants	11 participants n=107 Participants	22 participants n=206 Participants
Sex/Gender, Customized Female	14 participants n=99 Participants	15 participants n=107 Participants	29 participants n=206 Participants
Sex/Gender, Customized Male	15 participants n=99 Participants	17 participants n=107 Participants	32 participants n=206 Participants
Region of Enrollment United States	6 participants n=99 Participants	8 participants n=107 Participants	14 participants n=206 Participants
Region of Enrollment Italy	15 participants n=99 Participants	15 participants n=107 Participants	30 participants n=206 Participants
Region of Enrollment Sweden	5 participants n=99 Participants	4 participants n=107 Participants	9 participants n=206 Participants
Region of Enrollment Australia	3 participants n=99 Participants	5 participants n=107 Participants	8 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Population: population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).

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=65 implants Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant n=68 implants Patients with dental implant with internal connection and without the lateralized expanded platform design
Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit	-0.7440 millimeters Standard Error 0.1881	-0.8445 millimeters Standard Error 0.1439

SECONDARY outcome

Timeframe: four years

Outcome measures

Outcome data not reported

Adverse Events

Osseotite Certain Prevail Implant

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Osseotite Certain Implant

Serious events: 0 serious events

Other events: 5 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=29 participants at risk Patients with dental implant with internal connection and expanded, lateralized design at coronal portion	Osseotite Certain Implant n=32 participants at risk Patients with dental implant with internal connection and without the lateralized expanded platform design
Surgical and medical procedures Loss of integration of implant	17.2% 5/29 • Number of events 5 • Adverse events are collected and reported from day 1 of the study to present, 4 years of study duration to date. Adverse event data is collected by patient questioning and visual examination of patient's mouth each study event visit.	15.6% 5/32 • Number of events 5 • Adverse events are collected and reported from day 1 of the study to present, 4 years of study duration to date. Adverse event data is collected by patient questioning and visual examination of patient's mouth 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