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Predictability of Orthodontic Tooth Movement With Invisalign Aligners

2 de mayo de 2022 actualizado por: Tommaso Castroflorio, University of Turin, Italy

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.

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.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Actual)

98

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Turin, Italia, 10126
        • Department of Orthodontics of the University of Turin

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

11 años a 77 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

orthodontic patients affering to the department of Turin and patients affering to 5 private orthodontics offices across Italy

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Expert operators
A method of straightening teeth without fixed braces
Post-graduate students
A method of straightening teeth without fixed braces

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Predictable orthodontic movements with Invisalign aligners
Periodo de tiempo: 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 month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The impact of the orthodontist experience, on the predictability of orthodontic tooth movement with Invisalign aligners
Periodo de tiempo: 1 months
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
1 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Tommaso Castroflorio, DDS, PhD, Department of Orthodontics of the University of Turin

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de octubre de 2019

Finalización primaria (Actual)

21 de diciembre de 2021

Finalización del estudio (Actual)

31 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

26 de abril de 2022

Primero enviado que cumplió con los criterios de control de calidad

26 de abril de 2022

Publicado por primera vez (Actual)

2 de mayo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

2 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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