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Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement

NCT ID: NCT06516185

Last Updated: 2024-12-12

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

RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.

Detailed Description

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Once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. They will also be informed that they may cancel their participation in the study at any time. Patient will be allocated randomly in two groups: The first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.

Conditions

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Crowding, Tooth Tipped Tooth or Teeth Rotation of Tooth Malocclusion, Angle's Class

Keywords

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clear aligner therapy direct-printed aligner predictability shape memory stratification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is designed following CONSORT guidelines as a randomized equivalence clinical trial, controlled, with two parallel arms, and single-blind.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Direct-printed aligner

The experimental group will be treated with the aligner system fabricated by direct printing. The current protocols described in the literature and by the manufacturer for the fabrication of the printed orthodontic devices will be followed.

Group Type EXPERIMENTAL

direct-printed aligner

Intervention Type DEVICE

Patients will be treated with direct-printed aligners until dental alignment is achieved.

Thermoformed aligner

The control group will be treated with the thermoformed or gold standard aligner system. The established protocols for treatment with thermoformed clear aligners will be followed.

Group Type ACTIVE_COMPARATOR

thermoformed aligner

Intervention Type DEVICE

Patients will be treated with thermoformed aligners until dental alignment is achieved.

Interventions

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direct-printed aligner

Patients will be treated with direct-printed aligners until dental alignment is achieved.

Intervention Type DEVICE

thermoformed aligner

Patients will be treated with thermoformed aligners until dental alignment is achieved.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment
* Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries.
* No history of previous orthodontic treatment.
* Complete permanent dentition (excluding third molars, their presence or absence being irrelevant).

Exclusion Criteria

* Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs).
* Pregnant women.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Complutense University of Madrid

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alejandro Piñeda-Zayas

Role: CONTACT

Phone: +34626923397

Email: [email protected]

Alejandro Iglesias-Linares

Role: CONTACT

Email: [email protected]

Facility Contacts

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Alejandro Piñeda-Zayas

Role: primary

Alejandro Iglesias-Linares

Role: backup

Other Identifiers

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24/098-EC_P

Identifier Type: REGISTRY

Identifier Source: secondary_id

125-120324

Identifier Type: -

Identifier Source: org_study_id