Clinical trial NCT06561945: Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study
Official title: Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malocclusion
Keywords: clear aligner
malocclusion
direct print aligner
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65 years
2. Good general health
3. Presence of a dental/skeletal malocclusion
4. Permanent dentition with second molars completely erupted in the arch
5. Correct tooth shape, with sufficient height of the clinical crowns
6. Good compliance during treatment

Exclusion Criteria:

1. Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement
2. Orofacial malformations or syndromes
3. Periodontal disease
4. Smoke
5. Pregnancy
6. Signs and/or symptoms of temporomandibular disorders
7. Absence of teeth (except for third molars)
8. Dental Implants

Primary outcomes:
measure: Evaluate accuracy aligners of on transversal dental linear movements
timeFrame: 18 months
measure: Evaluate accuracy aligners of on vertical dental linear movements
timeFrame: 18 months
measure: Evaluate accuracy aligners of on sagittal dental linear movements
timeFrame: 18 months
Secondary outcomes:
measure: Evaluate accuracy of 3d printed aligners on transversal dental angular movements
timeFrame: 18 months
measure: Evaluate accuracy of 3d printed aligners on sagittal dental angular movements
timeFrame: 18 months
measure: Evaluate accuracy of 3d printed aligners on vertical dental angular movements
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Vita-Salute San Raffaele University Milan
name: Giorgio Gastaldi, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.