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

December 11, 2024 updated by: Universidad Complutense de Madrid

Randomized Clinical Trial on the Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alejandro Piñeda-Zayas
  • Phone Number: +34626923397
  • Email: apined01@ucm.es

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Complutense University of Madrid
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alejandro Iglesias-Linares
        • Sub-Investigator:
          • Paula Angulo-Acosta
        • Sub-Investigator:
          • Alexandra Dehesa-Santos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: direct-printed aligner
Patients will be treated with direct-printed aligners until dental alignment is achieved.
Active Comparator: 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.
Device: thermoformed aligner
Patients will be treated with thermoformed aligners until dental alignment is achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
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.
Time Frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMs of the patient undergoing direct-printed aligner treatment compared to the control group.
Time Frame: 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.
Participants will complete a validated pre-defined questionnaire [Patient-reported outcome measures (PROMs)] on treatment use and perceptions. The level of pain will be assessed using questionnaires.
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.
Time Frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
This will be assessed by quantifying the change between the predictability, varying the degree of inclination of the aligner print, expressed as a percentage (%).
Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 125-120324
  • 24/098-EC_P (Registry Identifier: Ethics Committee for Research involving medicinal products (IECm))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

Data will be available at the end of the clinical trial in June 2026

IPD Sharing Access Criteria

Upon request of the interested party

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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