Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study

NCT06561945 | Not Yet Recruiting

• 1 other identifier: CA-001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  18 months

Secondary Outcomes (3)

• Evaluate accuracy of 3d printed aligners on transversal dental angular movements

  18 months

• Evaluate accuracy of 3d printed aligners on sagittal dental angular movements

  18 months

• Evaluate accuracy of 3d printed aligners on vertical dental angular movements

  18 months

Study Arms (1)

orthodontic patients

Patients who need orthodontic treatment.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Related Publications (5)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Giorgio Gastaldi, MD, DDS

  Vita-Salute San Raffaele University Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Boggio, dds,phd

CONTACT

00393339019030; a.boggio@docenti.unisr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: August 20, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share