MalocclusionNCT06561945
Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study
An observational study of Malocclusion, run by IRCCS Ospedale San Raffaele.
Trial summary
The aim of the present prospective observational study is to evaluate the accuracy of dental movements in the three planes of space, assessing the correspondence between the virtual planned movements and the clinical outcomes achieved using thermoformed or 3D printed orthodontic aligners. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be selected from patients aged 18 years and older who require orthodontic treatment with clear aligners. One hundred patients will be enrolled, without distinction based on gender.
Who may be able to join
- Age between 18 and 65 years
- Good general health
- Presence of a dental/skeletal malocclusion
- Permanent dentition with second molars completely erupted in the arch
- Correct tooth shape, with sufficient height of the clinical crowns
- Good compliance during treatment
Who cannot join
- Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement
- Orofacial malformations or syndromes
- Periodontal disease
- Smoke
- Pregnancy
- Signs and/or symptoms of temporomandibular disorders
- Absence of teeth (except for third molars)
- Dental Implants
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the present prospective observational study is to evaluate the accuracy of dental movements in the three planes of space, assessing the correspondence between the virtual planned movements and the clinical outcomes achieved using thermoformed or 3D printed orthodontic aligners. The study will include patients who are candidates for aligner orthodontics treatment. After having acquired the standard initial diagnostic data (clinical examination, intra- and extra-oral photographs, intra- and extra-oral scans, orthopantomography and lateral-lateral teleradiography of the skull), the digital impressions of the arches will be used to plan the dental movements necessary for correction of malocclusion.
The aligners will then be designed using orthodontic CAD software and realized using a thermoformed and direct 3D printing process.
All patients will be treated following current recommendations relating to the orthodontic treatments in question. After delivery of the aligners, during each check-up, intra-oral and extra-oral scans will be acquired to evaluate the actual position of the teeth and, using special software will be compare the virtually designed position with tooth with the clinical outcomes. Any discrepancies will be recorded and statistically analyzed.There are no additional invasive procedures. Intra- and extra-oral scans will be acquired regularly to monitor the extent of tooth movement over time.
- Conditions
- Malocclusion
- Keywords
- clear aligner, malocclusion, direct print aligner
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| orthodontic patients | Patients who need orthodontic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate accuracy aligners of on transversal dental linear movements
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the transversal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Measured: 18 months
Evaluate accuracy aligners of on vertical dental linear movements
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the vertical plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Measured: 18 months
Evaluate accuracy aligners of on sagittal dental linear movements
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the sagittal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Measured: 18 months
Secondary outcomes (3)
Evaluate accuracy of 3d printed aligners on transversal dental angular movements
Correspondence between virtual planned angular movements (in degrees) and clinical outcomes achieved using aligners evaluated on the transversal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Measured: 18 months
Evaluate accuracy of 3d printed aligners on sagittal dental angular movements
Correspondence between virtual planned angular movements (in degrees) and clinical outcomes achieved using aligners evaluated on the sagittal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Measured: 18 months
Evaluate accuracy of 3d printed aligners on vertical dental angular movements
Correspondence between virtual planned angular movements (in degrees) and clinical outcomes achieved using aligners evaluated on the vertical plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Gastaldi, IRCCS Ospedale San Raffaele
- Investigators
- Giorgio Gastaldi, MD, DDS, Principal investigator, Vita-Salute San Raffaele University Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561945
- Sponsor's protocol ID
- CA-001
- Status last verified
- Oct 2024
- First submitted
- 14 Jul 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferlias N, Dalstra M, Cornelis MA, Cattaneo PM. In Vitro Comparison of Different Invisalign(R) and 3Shape(R) Attachment Shapes to Control Premolar Rotation. Front Bioeng Biotechnol. 2022 Mar 16;10:840622. doi: 10.3389/fbioe.2022.840622. eCollection 2022.
PubMed 35372304Grunheid T, Loh C, Larson BE. How accurate is Invisalign in nonextraction cases? Are predicted tooth positions achieved? Angle Orthod. 2017 Nov;87(6):809-815. doi: 10.2319/022717-147.1. Epub 2017 Jul 7.
PubMed 28686090Houle JP, Piedade L, Todescan R Jr, Pinheiro FH. The predictability of transverse changes with Invisalign. Angle Orthod. 2017 Jan;87(1):19-24. doi: 10.2319/122115-875.1. Epub 2016 Jun 15.
PubMed 27304231Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.
PubMed 19121497Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.
PubMed 30264270
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06561945
- Acronym / sponsor ID
- CA-001
- Conditions
- Malocclusion
- Keywords
- clear aligner, malocclusion, direct print aligner
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Aug 2024 (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.
The aim of the present prospective observational study is to evaluate the accuracy of dental movements in the three planes of space, assessing the correspondence between the virtual planned movements and the clinical outcomes achieved using thermoformed or 3D printed orthodontic aligners. The study will include patients who are candidates for aligner orthodontics treatment. After having acquired the standard initial diagnostic data (clinical examination, intra- and extra-oral photographs, intra- and extra-oral scans, orthopantomography and lateral-lateral teleradiography of the skull), the digital impressions of the arches will be used to plan the dental movements necessary for correction of malocclusion.
The aligners will then be designed using orthodontic CAD software and realized using a thermoformed and direct 3D printing process.
All patients will be treated following current recommendations relating to the orthodontic treatments in question. After delivery of the aligners, during each check-up, intra-oral and extra-oral scans will be acquired to evaluate the actual position of the teeth and, using special software will be compare the virtually designed position with tooth with the clinical outcomes. Any discrepancies will be recorded and statistically analyzed.There are no additional invasive procedures. Intra- and extra-oral scans will be acquired regularly to monitor the extent of tooth movement over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orthodontic patients | – | –Patients who need orthodontic treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from patients aged 18 years and older who require orthodontic treatment with clear aligners. One hundred patients will be enrolled, without distinction based on gender.
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Good general health
- Presence of a dental/skeletal malocclusion
- Permanent dentition with second molars completely erupted in the arch
- Correct tooth shape, with sufficient height of the clinical crowns
Key exclusion criteria (8 listed)
- Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement
- Orofacial malformations or syndromes
- Periodontal disease
- Smoke
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate accuracy aligners of on transversal dental linear movements
Time frame: 18 months
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the transversal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Evaluate accuracy aligners of on vertical dental linear movements
Time frame: 18 months
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the vertical plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
Evaluate accuracy aligners of on sagittal dental linear movements
Time frame: 18 months
Correspondence between virtual planned linear movements (in millimetres) and clinical outcomes achieved using aligners evaluated on the sagittal plane. Post-treatment digital models and final virtual treatment plan models will be exported as STL files and subsequently imported into Geomagic Qualify ®software, to compare final teeth positions
3 secondary outcomes
Evaluate accuracy of 3d printed aligners on transversal dental angular movements
Time frame: 18 months
Evaluate accuracy of 3d printed aligners on sagittal dental angular movements
Time frame: 18 months
Evaluate accuracy of 3d printed aligners on vertical dental angular movements
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Results publication: PubMed 35372304Ferlias N, Dalstra M, Cornelis MA, Cattaneo PM. In Vitro Comparison of Different Invisalign(R) and 3Shape(R) Attachment Shapes to Control Premolar Rotation. Front Bioeng Biotechnol. 2022 Mar 16;10:840622. doi: 10.3389/fbioe.2022.840622. eCollection 2022.
- Results publication: PubMed 28686090Grunheid T, Loh C, Larson BE. How accurate is Invisalign in nonextraction cases? Are predicted tooth positions achieved? Angle Orthod. 2017 Nov;87(6):809-815. doi: 10.2319/022717-147.1. Epub 2017 Jul 7.
- Results publication: PubMed 27304231Houle JP, Piedade L, Todescan R Jr, Pinheiro FH. The predictability of transverse changes with Invisalign. Angle Orthod. 2017 Jan;87(1):19-24. doi: 10.2319/122115-875.1. Epub 2016 Jun 15.
- Results publication: PubMed 19121497Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.
- Results publication: PubMed 30264270Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.
- Individual participant dataSharing planned: No
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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.
Giorgio Gastaldi, MD, DDS principal investigator
Vita-Salute San Raffaele University Milan
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by IRCCS Ospedale San Raffaele.
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 8 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: opening soon, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Boggio, dds,phd (00393339019030, a.boggio@docenti.unisr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate accuracy aligners of on transversal dental linear movements (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561945, which also lists 5 linked publications.
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 21 Oct 2024.