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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Biomet, Inc.

ClinicalTrials.gov Identifier:

NCT00723944

First received: July 25, 2008

Last updated: October 17, 2011

Last verified: October 2011

History of Changes

Results First Received: June 26, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Partial Edentulism Tooth Disease
Interventions:	Device: Osseotite Prevail Certain Prevail Device: Osseotite Certain

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow for 4 periods

Period 1: Implant Placement Surgery

	Osseotite Certain Prevail Implant	Osseotite Certain Implant
STARTED	52 ^[1]	50 ^[2]
COMPLETED	52 ^[3]	50 ^[4]
NOT COMPLETED	0	0

[1]	number of individual implant units is 148
[2]	number of individual implant units is 138
[3]	number of individual implant units completing is 148
[4]	number of individual implant units completing is 138

Period 2: Permanent Prosthesis Placement

	Osseotite Certain Prevail Implant	Osseotite Certain Implant
STARTED	52 ^[1]	50 ^[2]
COMPLETED	49 ^[3]	41 ^[4]
NOT COMPLETED	3	9
Adverse Event	1	7
Lost to Follow-up	2	2

[1]	number of individual implant units is 148
[2]	number of individual implant units is 138
[3]	number of individual implant units completing is 134
[4]	number of individual implant units completing is 112

Period 3: One Year Post Placement Follow-up

	Osseotite Certain Prevail Implant	Osseotite Certain Implant
STARTED	49 ^[1]	41 ^[2]
COMPLETED	48 ^[3]	37 ^[4]
NOT COMPLETED	1	4
Lost to Follow-up	1	4

[1]	number of individual implant units is 134
[2]	number of individual implant units is 112
[3]	number of individual implant units completing is 130
[4]	number of individual implant units completing is 108

Period 4: Two Year Post Placement Follow-up

	Osseotite Certain Prevail Implant	Osseotite Certain Implant
STARTED	48 ^[1]	37 ^[2]
COMPLETED	48 ^[3]	37 ^[4]
NOT COMPLETED	0	0

[1]	number of individual implant units is 130
[2]	number of individual implant units is 108
[3]	number of individual implant units completing is 130
[4]	number of individual implant units completing is 108

Baseline Characteristics

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Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	Osseotite Certain Prevail Implant	Osseotite Certain Implant	Total
Number of Participants [units: participants]	52	50	102
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	40	38	78
>=65 years	12	12	24
Gender [units: participants]
Female	21	19	40
Male	31	31	62
Region of Enrollment [units: participants]
United States	14	16	30
Italy	19	17	36
France	6	5	11
Germany	8	8	16
Sweden	5	4	9

Outcome Measures

1. Primary:

Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit [ Time Frame: 1 year ]

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Measure Type	Primary
Measure Title	Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
Measure Description	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.
Time Frame	1 year
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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

Measured Values

	Osseotite Certain Prevail Implant	Osseotite Certain Implant
Number of Participants Analyzed [units: participants]	48	37
Number of implants Analyzed [units: implants]	130	108
Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit [units: millimeters] Mean ± Standard Error	-0.7705 ± 0.1567	-0.6648 ± .1158

No statistical analysis provided for Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit

2. Secondary:

Osseous Integration [ Time Frame: 4 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: James N. Kenealy, Pharm.D.
Organization: Biomet 3i LLC
phone: 5617766817
e-mail: jim.kenealy@biomet.com

No publications provided

Responsible Party:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00723944 History of Changes
Other Study ID Numbers:	2302
Study First Received:	July 25, 2008
Results First Received:	June 26, 2009
Last Updated:	October 17, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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