Trial Outcomes & Findings for An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation (NCT NCT00725049)
NCT ID: NCT00725049
Last Updated: 2024-02-20
Results Overview
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
3 years
Results posted on
2024-02-20
Participant Flow
Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began February 2009 and ended February 2011. All study patients were enrolled at 3 European Universities (dental clinics).
Participant milestones
| Measure |
Dental Implant (Nanotite)
Dental implants of short length placed without sinus lifts
|
Control Group
Dental implants of standard length placed simultaneously with sinus augmentation
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation
Baseline characteristics by cohort
| Measure |
Dental Implant (Nanotite)
n=17 Participants
Dental implants of short length placed without sinus lifts
|
Control Group
n=20 Participants
Dental implants of standard length placed simultaneously with sinus augmentation
|
Total
n=37 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
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Number of participants used in analysis selected as per protocol
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
Outcome measures
| Measure |
Dental Implant (Nanotite)
n=31 Dental implants
Dental implants of short length placed without sinus lifts
|
Control Group
n=35 Dental implants
Dental implants of standard length placed simultaneously with sinus augmentation
|
|---|---|---|
|
Integration Success of Implant
|
17 participants
|
20 participants
|
Adverse Events
Dental Implant (Nanotite)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dental Implant (Nanotite)
n=17 participants at risk
Dental implants of short length placed without sinus lifts
|
Control Group
n=20 participants at risk
Dental implants of standard length placed simultaneously with sinus augmentation
|
|---|---|---|
|
Surgical and medical procedures
Mobility
|
35.3%
6/17 • Number of events 6 • Adverse events are collected and reported from day 1 of the study to present time (entire duration of study).
Adverse event data is collected by patient questioning and visual examination of patient's mouth during each study visit.
|
25.0%
5/20 • Number of events 5 • Adverse events are collected and reported from day 1 of the study to present time (entire duration of study).
Adverse event data is collected by patient questioning and visual examination of patient's mouth during each study visit.
|
Additional Information
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