Dentition/Teeth Measurement
Conditions
Brief summary
The purpose of this study is to evaluate the validity, reliability and reproducibility of digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster models.
Detailed description
The primary objective of this study is to evaluate the validity, reliability and reproducibility of the dental measurements obtained on the digital models with iTero® in comparison with those obtained on the plaster models (gold standard) and on the digital models with Lava Digital®. The secondary objective is to compare two different impression materials (i.e. alginate and polyvinylsiloxane (PVS)) and determine whether the impression material used affects the accuracy of the measurements. Statistical analysis: * Intraclass correlation coefficient (ICC) will be used to evaluate the intra- and inter-operator reliability of the measurements for each method, i.e. the plaster models and the digital models. * A paired t-test will be used to determine the validity of the digital measurements with iTero®, and to compare the impression materials (alginate and PVS). * A Bland-Altman plot will also be used to compare the two digital methods (Lava Digital® et iTero®) with the plaster models. * Dahlberg coefficient will be used to evaluate the technical error associated with the measurements that will be made.
Interventions
None listed
Sponsors
Université de Montréal
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 12 and 30 years old (male or female) * complete permanent dentition from first molar to the other first molar * no interproximal modifications (e.g. decay, large restorations, abnormal tooth morphology) which could affect the mesio-distal width of the teeth
Exclusion criteria
* Dentition with severe crowding (that could therefore affect the mesio-distal width of the teeth)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overjet | one year | 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iTero, Lava Digital and Plaster Models All study participants: iTero, LavaDigital and plaster models (single-group study) | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | iTero, Lava Digital and Plaster Models |
|---|---|
| Age, Categorical <=18 years | 23 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment Canada | 25 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Overjet
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
Time frame: one year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iTero Models | Overjet | 0.25 mm |
| Plaster Models | Overjet | 0.27 mm |
| Lava Digital Models | Overjet | 0.28 mm |