Tooth CrowdingNCT05356780
Predictability of Orthodontic Tooth Movement With Invisalign Aligners
An observational study of Tooth Crowding and Malocclusion, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Together with the increased adult patient demand for orthodontic treatment and the push toward increasingly personalized treatment, technology developments have resulted in a growing worldwide demand for clear aligners, to the point that they are now an essential part of any orthodontic practice. Read more about this study
- Who is it for?
- Ages 11 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Crowding, Malocclusion, Malocclusion, Angle Class II
- What is being tested?
- Aligner
- Type of treatment
- Medical device
- How many people
- 98 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2019to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 77 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: orthodontic patients affering to the department of Turin and patients affering to 5 private orthodontics offices across Italy
Who may be able to join
- complete permanent dentition, with the exception of third molars;
- Invisalign treatment in both arches;
- active tooth movements programmed at the standard rate recommended by the Align Tech technician;
- no intermediate corrections or additional aligners;
- aligners change every 7 to 14 days;
- good patient compliance.
Who cannot join
- need for oral surgery or dental restorations;
- failure to complete the initial series of aligners;
- combo treatments (i.e. combination of aligners with any other orthodontic appliance);
- poor patient cooperation;
- previous orthodontic treatment;
- presence of prosthetic restorations and/or periodontal problems
- signs and/or symptoms of temporomandibular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictability of Orthodontic Tooth Movement With Invisalign Aligners: Effect of Treatment Design and Operator Experience
Together with the increased adult patient demand for orthodontic treatment and the push toward increasingly personalized treatment, technology developments have resulted in a growing worldwide demand for clear aligners, to the point that they are now an essential part of any orthodontic practice.
Despite the widespread use of the technique, the existing literature about reliability of orthodontic tooth movement with Invisalign aligners seems not encouraging. Several papers have demonstrated that what is virtually planned is not what is clinically achievable. However, it should be considered that clear aligner orthodontics techniques are customized not only for the patients but for orthodontists too. Therefore, virtual treatment plan design, in terms of attachments' design and placement, orthodontic tooth movement (OTM) staging and aligner deformation overengineering, or in other words aligners biomechanics knowledge, plays a crucial role in defining the quality of the orthodontic treatment with Invisalign aligners.
Read more
Based on these considerations the present study was designed to answer two research-clinical questions: 1) which are the less predictable orthodontic movements with Invisalign aligners when the treatment plan is designed by expert operators? and 2) which is the impact of the orthodontist experience, in terms of patient motivation, on the predictability of orthodontic tooth movement with Invisalign aligners? To answer those questions, the predictability of OTM in a sample of Invisalign patients treated by expert operators was compared with the predictability of OTM in a sample treated by post-graduate students.
The null hypothesis for question 1 is that all the prescribed orthodontic tooth movements are predictable, while the null hypothesis for question 2 is that the reliability of orthodontic tooth movement is not affected by operator experience.
98 patients (31 M, 67 F; mean age 28 ± 12 years) were selected among those in treatment at the Department of Orthodontics of the University of Turin, which is the coordinating center, and at 5 private orthodontics offices across Italy. The inclusion criteria for practitioners were as follows: orthodontist with huge and renewed experience in Invisalign treatments; has the ability to scan plaster model or to collect intraoral scans and upload (via internet) the files obtained to a central repository; affirms that the practice can devote sufficient time in patient scheduling to allow focused recording of all data required for the study; and does not anticipate retiring, selling the practice, or moving during the study. Signed, written informed consent was required before inclusion in the trial.
All participants included in this prospective observational study had Class I or mild Class II malocclusion with mild to moderate crowding or spacing in the maxillary and mandibular dental arches (nonextraction cases). Interproximal enamel reduction was performed as prescribed in each patient's virtual treatment plan.
The average treatment time was 10 ± 5 months. The sample considered a total of 2716 teeth that were analyzed overlapping the real post-treatment .stl file obtained with the final intra-oral scan to the planned post-treatment .stl file obtained exporting the final stage of the virtual setup.
Every virtual treatment plan was designed by orthodontists with a huge and renewed experience in Invisalign treatments. While in the private practices the treatment was directly conducted by 5 expert orthodontist (mean age 45.6 ± 8.2) who controlled the patient at every appointment, in the University setting the treatment was conducted by 5 post-graduate students at the last year of their program (mean age 26.4± 1.4). Control appointments were fixed at 6 weeks interval in both the University and the private settings.
Posttreatment digital models and final virtual treatment plan models were exported from ClinCheck® software as stereolithography files and subsequently imported into Geomagic Qualify software (3D Systems(r), Rock Hill, South Carolina, USA), in order to compare individual tooth positions between digital models of each patient. The dental arches were superimposed using the landmark-based method and the surface-based method (Best Fit Alignment). So that the differences between the tooth positions could be calculated, 3 reference planes were identified on the virtual treatment plan model. Differences between the actual treatment outcome and the predicted outcome were calculated and tested for statistical significance for each tooth in the mesial-distal, vestibular-lingual, and occlusal-gingival directions, as well as for angulation, inclination, and rotation. Differences greater than 0.5 mm for linear measurements and 2° for angular measurements were considered clinically significant. In addition, the statistical significance of categorical variables was tested for each previously calculated difference in tooth movement.
- Being tested
- Aligner
- Keywords
- Biomechanics, Aligner orthodontics, Adult patients, Orthodontic Tooth Movement predictability
- Medical subject headings
- Malocclusion, Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlignerDevice
A method of straightening teeth without fixed braces
| Study group | Role | What they receive |
|---|---|---|
| Expert operators | Not described Receives: Device: Aligner | |
| Post-graduate students | Not described Receives: Device: Aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictable orthodontic movements with Invisalign aligners
Differences between the actual treatment outcome and the predicted outcome were calculated and tested for statistical significance for each tooth in the mesial-distal, vestibular-lingual, and occlusal-gingival directions, as well as for angulation, inclination, and rotation. Differences greater than 0.5 mm for linear measurements and 2° for angular measurements were considered clinically significant. In addition, the statistical significance of categorical variables was tested for each previously calculated difference in tooth movement.
Measured: 1 month
Secondary outcomes (1)
The impact of the orthodontist experience, on the predictability of orthodontic tooth movement with Invisalign aligners
The predictability of OTM in a sample of Invisalign patients treated by expert operators was compared with the predictability of OTM in a sample treated by post-graduate students
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start12 Oct 2019
- Primary completion21 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth CrowdingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Castroflorio, University of Turin, Italy
- Investigators
- Tommaso Castroflorio, DDS, PhD, Study chair, Department of Orthodontics of the University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356780
- Sponsor's protocol ID
- 157/2020
- Status last verified
- May 2022
- First submitted
- 26 Apr 2022
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Orthodontic Tooth Movement With Invisalign Aligners: Effect of Treatment Design and Operator Experience
- ClinicalTrials.gov ID
- NCT05356780
- Acronym / sponsor ID
- 157/2020
- Keywords
- Biomechanics, Aligner orthodontics, Adult patients, Orthodontic Tooth Movement predictability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Together with the increased adult patient demand for orthodontic treatment and the push toward increasingly personalized treatment, technology developments have resulted in a growing worldwide demand for clear aligners, to the point that they are now an essential part of any orthodontic practice.
Despite the widespread use of the technique, the existing literature about reliability of orthodontic tooth movement with Invisalign aligners seems not encouraging. Several papers have demonstrated that what is virtually planned is not what is clinically achievable. However, it should be considered that clear aligner orthodontics techniques are customized not only for the patients but for orthodontists too. Therefore, virtual treatment plan design, in terms of attachments' design and placement, orthodontic tooth movement (OTM) staging and aligner deformation overengineering, or in other words aligners biomechanics knowledge, plays a crucial role in defining the quality of the orthodontic treatment with Invisalign aligners.
Based on these considerations the present study was designed to answer two research-clinical questions: 1) which are the less predictable orthodontic movements with Invisalign aligners when the treatment plan is designed by expert operators? and 2) which is the impact of the orthodontist experience, in terms of patient motivation, on the predictability of orthodontic tooth movement with Invisalign aligners? To answer those questions, the predictability of OTM in a sample of Invisalign patients treated by expert operators was compared with the predictability of OTM in a sample treated by post-graduate students.
The null hypothesis for question 1 is that all the prescribed orthodontic tooth movements are predictable, while the null hypothesis for question 2 is that the reliability of orthodontic tooth movement is not affected by operator experience.
98 patients (31 M, 67 F; mean age 28 ± 12 years) were selected among those in treatment at the Department of Orthodontics of the University of Turin, which is the coordinating center, and at 5 private orthodontics offices across Italy. The inclusion criteria for practitioners were as follows: orthodontist with huge and renewed experience in Invisalign treatments; has the ability to scan plaster model or to collect intraoral scans and upload (via internet) the files obtained to a central repository; affirms that the practice can devote sufficient time in patient scheduling to allow focused recording of all data required for the study; and does not anticipate retiring, selling the practice, or moving during the study. Signed, written informed consent was required before inclusion in the trial.
All participants included in this prospective observational study had Class I or mild Class II malocclusion with mild to moderate crowding or spacing in the maxillary and mandibular dental arches (nonextraction cases). Interproximal enamel reduction was performed as prescribed in each patient's virtual treatment plan.
The average treatment time was 10 ± 5 months. The sample considered a total of 2716 teeth that were analyzed overlapping the real post-treatment .stl file obtained with the final intra-oral scan to the planned post-treatment .stl file obtained exporting the final stage of the virtual setup.
Every virtual treatment plan was designed by orthodontists with a huge and renewed experience in Invisalign treatments. While in the private practices the treatment was directly conducted by 5 expert orthodontist (mean age 45.6 ± 8.2) who controlled the patient at every appointment, in the University setting the treatment was conducted by 5 post-graduate students at the last year of their program (mean age 26.4± 1.4). Control appointments were fixed at 6 weeks interval in both the University and the private settings.
Posttreatment digital models and final virtual treatment plan models were exported from ClinCheck® software as stereolithography files and subsequently imported into Geomagic Qualify software (3D Systems(r), Rock Hill, South Carolina, USA), in order to compare individual tooth positions between digital models of each patient. The dental arches were superimposed using the landmark-based method and the surface-based method (Best Fit Alignment). So that the differences between the tooth positions could be calculated, 3 reference planes were identified on the virtual treatment plan model. Differences between the actual treatment outcome and the predicted outcome were calculated and tested for statistical significance for each tooth in the mesial-distal, vestibular-lingual, and occlusal-gingival directions, as well as for angulation, inclination, and rotation. Differences greater than 0.5 mm for linear measurements and 2° for angular measurements were considered clinically significant. In addition, the statistical significance of categorical variables was tested for each previously calculated difference in tooth movement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expert operators | – | Device: Aligner |
| Post-graduate students | – | Device: Aligner |
Who may qualify
- Ages
- 11 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- orthodontic patients affering to the department of Turin and patients affering to 5 private orthodontics offices across Italy
Key inclusion criteria (6 listed)
- complete permanent dentition, with the exception of third molars;
- Invisalign treatment in both arches;
- active tooth movements programmed at the standard rate recommended by the Align Tech technician;
- no intermediate corrections or additional aligners;
- aligners change every 7 to 14 days;
Key exclusion criteria (7 listed)
- need for oral surgery or dental restorations;
- failure to complete the initial series of aligners;
- combo treatments (i.e. combination of aligners with any other orthodontic appliance);
- poor patient cooperation;
- previous orthodontic treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlignerA method of straightening teeth without fixed braces | Device | Expert operators, Post-graduate students |
Primary outcome
Predictable orthodontic movements with Invisalign aligners
Time frame: 1 month
Differences between the actual treatment outcome and the predicted outcome were calculated and tested for statistical significance for each tooth in the mesial-distal, vestibular-lingual, and occlusal-gingival directions, as well as for angulation, inclination, and rotation. Differences greater than 0.5 mm for linear measurements and 2° for angular measurements were considered clinically significant. In addition, the statistical significance of categorical variables was tested for each previously calculated difference in tooth movement.
1 secondary outcome
The impact of the orthodontist experience, on the predictability of orthodontic tooth movement with Invisalign aligners
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
Related trials for Tooth Crowding
Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommaso Castroflorio, DDS, PhD study chair
Department of Orthodontics of the University of Turin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Crowding and Malocclusion, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictable orthodontic movements with Invisalign aligners (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.