Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malocclusion. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Evaluate accuracy aligners of on transversal dental linear movements [Time frame: 18 months]
- Evaluate accuracy aligners of on vertical dental linear movements [Time frame: 18 months]
- Evaluate accuracy aligners of on sagittal dental linear movements [Time frame: 18 months]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 35372304
- Grunheid 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. PMID 28686090
- Houle 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. PMID 27304231
- Kravitz 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. PMID 19121497
- Papadimitriou 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. PMID 30264270
Identifiers
NCT: NCT06561945 · CA-001