Trial Outcomes & Findings for Validity of Digital Models Obtained With iTero® and Lava Digital® in Comparison With Plaster Models. (NCT NCT01934517)
NCT ID: NCT01934517
Last Updated: 2016-02-15
Results Overview
Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor
Recruitment status
COMPLETED
Target enrollment
25 participants
Primary outcome timeframe
one year
Results posted on
2016-02-15
Participant Flow
Participant milestones
| Measure |
iTero, Lava Digital and Plaster Models: All Study Participants
Single-group study:
1. ITero models obtained from intraoral scans with iTero scanner
2. Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
3. Lava Digital models obtained from extraoral scans of plaster models
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validity of Digital Models Obtained With iTero® and Lava Digital® in Comparison With Plaster Models.
Baseline characteristics by cohort
| Measure |
iTero, Lava Digital and Plaster Models
n=25 Participants
All study participants: iTero, LavaDigital and plaster models (single-group study)
|
|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearOverjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor
Outcome measures
| Measure |
iTero Models
n=25 Participants
ITero models obtained from intraoral scans with iTero scanner
|
Plaster Models
n=25 Participants
Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
|
Lava Digital Models
n=25 Participants
Lava Digital models obtained from extraoral scans of plaster models
|
|---|---|---|---|
|
Overjet
|
0.25 mm
Interval -0.65 to 1.16
|
0.27 mm
Interval -0.78 to 1.25
|
0.28 mm
Interval -0.58 to 1.2
|
Adverse Events
iTero Models
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Plaster Models
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lava Digital Models
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place