Trial Outcomes & Findings for A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs (NCT NCT00726063)

NCT ID: NCT00726063

Last Updated: 2022-03-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 241 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2022-03-28

Participant Flow

Up to 165 patients are expected to be enrolled across all centers, with enrollment efforts beginning in August 2008. Enrollment period remained opent until December 2010.

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

Participant milestones

Measure	Nanotite Implant Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant	Osseotite Implant Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant
Overall Study STARTED	122	119
Overall Study COMPLETED	113	112
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Measure	Nanotite Implant Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant	Osseotite Implant Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant
Overall Study Adverse Event	9	7

Baseline Characteristics

A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs

Baseline characteristics by cohort

Measure	Nanotite Implant n=122 Participants Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant	Osseotite Implant n=119 Participants Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant	Total n=241 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	63 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical >=65 years	60 Participants n=5 Participants	56 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	64 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	55 Participants n=7 Participants	116 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Number of implants surviving (lack of mobility) at the end of the study (time of analysis)

Outcome measures

Measure	Nanotite Implant n=239 Implants Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant	Osseotite Implant n=246 Implants Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant
Integration Success of the Implant	230 implants	239 implants

Adverse Events

Nanotite Implant

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Osseotite Implant

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nanotite Implant n=122 participants at risk Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant	Osseotite Implant n=119 participants at risk Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant
Surgical and medical procedures Loss of integration of implant	7.4% 9/122 • Number of events 9 • Adverse events are collected and reported throughout the duration of the study, an average of 2 years. Adverse event data is collected by patient questioning,visual examination, and radiologic assessment of patient's treatment area each study event visit.	5.9% 7/119 • Number of events 7 • Adverse events are collected and reported throughout the duration of the study, an average of 2 years. Adverse event data is collected by patient questioning,visual examination, and radiologic assessment of patient's treatment area each study event visit.

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