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Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite

NCT07420777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-05-11

No results posted yet for this study

Summary

The goal of this randomised clinical trial study is to investigate 3D-printed shape memory aligners in the treatment of anterior dental open bite adult patients. The main questions it aims to answer are:

1. Do 3D-direct-printed shape memory aligners demonstrate potentiality in the management of AOB?
2. What is the effect of 3D-direct printed shape memory aligners on molar intrusion?
3. Can the 3D-direct printed shape memory aligners extrude anterior teeth without the use of attachments?
4. Do 3D-direct printed shape memory aligners generate greater/higher stress distribution and initial teeth displacement compared to conventional clear aligners? Researchers will compare three groups: Group I: Patients treated with conventional clear aligners with attachments; Group II: Patients treated with 3D direct-printed shape-memory aligner without attachment; Group III: Patients treated with 3D direct-printed shape memory clear aligners with attachments and see its effect on anterior open bite treatment.

Participants will wear a clear aligner for about 6-8 months. Then

Conditions

  • Open Bite

Interventions

DEVICE

SMA with attachment

3D direct-printed shape memory clear aligner with horizontal rectangular attachment

DEVICE

SMA without attachments

3D direct-printed shape memory clear aligner without horizontal rectangular attachment

DEVICE

CA with attachment

Thermoformed conventional clear aligner with horizontal rectangular attachment

Sponsors & Collaborators

  • Kufa University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-26
Completion
2027-03-27

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07420777 on ClinicalTrials.gov