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

NCT06516185 | Recruiting

• 2 other identifiers: 125-12032424/098-EC_P
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

clear aligner therapy; direct-printed aligner; predictability; shape memory; stratification

Outcome Measures

Primary Outcomes (2)

• Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners.

  The primary outcome will be quantified through a continuous numerical variable, tooth movement efficiency or predictability (%) measured as the change between the final, intra-treatment and initial position for each of the individual movements studied, expressed as a percentage (%). The end of treatment or endpoint (E1) of this study will be established when the measurement of Little's Irregularity Index (hereafter LII) LII=0.

  Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.

• impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries.

  This will be assessed by quantifying the change between the predictability with auxiliaries and without auxiliaries for each of the individual movements studied respectively, expressed as a percentage (%).

  Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.

Secondary Outcomes (2)

• PROMs of the patient undergoing direct-printed aligner treatment compared to the control group.

  These should be completed five times after each visit (at 24 hours, 48 hours, 72 hours, 7 days and 14 days of aligner use) until reaching the defined endpoint (crowding resolution, LII=0), an average of 6 months.

• influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print.

  Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.

Study Arms (2)

Direct-printed aligner

EXPERIMENTAL

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.

Device: direct-printed aligner

Thermoformed aligner

ACTIVE COMPARATOR

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.

Device: thermoformed aligner

Interventions

direct-printed aligner DEVICE

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

Direct-printed aligner

thermoformed aligner DEVICE

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

Thermoformed aligner

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University of Madrid

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Alejandro Piñeda-Zayas

CONTACT

+34626923397; apined01@ucm.es

Alejandro Iglesias-Linares

CONTACT

aleigl01@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 23, 2024
• Study Start: October 22, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available at the end of the clinical trial in June 2026
• Access Criteria: Upon request of the interested party

Locations

ES (1)