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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2028-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Malocclusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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orthodontic patients

Patients who need orthodontic treatment.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes