Trial Outcomes & Findings for Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL) (NCT NCT00713206)

NCT ID: NCT00713206

Last Updated: 2023-07-13

Results Overview

All surviving implants at the end of study (3 years)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 122 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2023-07-13

Participant Flow

Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began September 2006 and ended May 2008.

Unit of analysis: dental implant

Participant milestones

Measure	Treatment Group Dental implants placed simultaneously with graft augmentation material.	Control Group Dental implants placed into graft augmentation material that has four months to heal.
Overall Study STARTED	65 158	57 140
Overall Study COMPLETED	60 152	53 131
Overall Study NOT COMPLETED	5 6	4 9

Reasons for withdrawal

Measure	Treatment Group Dental implants placed simultaneously with graft augmentation material.	Control Group Dental implants placed into graft augmentation material that has four months to heal.
Overall Study Lost to Follow-up	4	4
Overall Study Death	1	0

Baseline Characteristics

Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)

Baseline characteristics by cohort

Measure	Treatment Group n=62 Participants Dental implants placed simultaneously with graft augmentation material.	Control Group n=30 Participants Dental implants placed into graft augmentation material that has four months to heal.	Total n=92 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	60 Participants n=5 Participants	23 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	17 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	13 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment Italy	44 participants n=5 Participants	19 participants n=7 Participants	63 participants n=5 Participants
Region of Enrollment Spain	9 participants n=5 Participants	5 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Portugal	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: dental implants

All surviving implants at the end of study (3 years)

Outcome measures

Measure	Treatment Group n=158 dental implant Dental implants placed simultaneously with graft augmentation material.	Control Group n=140 dental implant Dental implants placed into graft augmentation material that has four months to heal.
Implants Not Mobile (Not Failing) at End of 3 Years	158 dental implant	140 dental implant

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 year

Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Group n=65 participants at risk Dental implants placed simultaneously with graft augmentation material.	Control Group n=57 participants at risk Dental implants placed into graft augmentation material that has four months to heal.
Surgical and medical procedures Mobility	3.1% 2/65 • Number of events 65 • Adverse events are collected and reported from day 1 up to 3 years (end of the study) Adverse event data is collected by patient questioning and visual examination of patient's mouth during each study visit	1.8% 1/57 • Number of events 57 • Adverse events are collected and reported from day 1 up to 3 years (end of the study) Adverse event data is collected by patient questioning and visual examination of patient's mouth during each study 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