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

NCT07420777 | Not Yet Recruiting

• 1 other identifier: MEC-271
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Do 3D-direct-printed shape memory aligners demonstrate potentiality in the management of AOB?
2. 2.What is the effect of 3D-direct printed shape memory aligners on molar intrusion?
3. 3.Can the 3D-direct printed shape memory aligners extrude anterior teeth without the use of attachments?
4. 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.

Conditions

Open Bite

Keywords

open bite; clear aligner; memory shape; 3D direct printed

Outcome Measures

Primary Outcomes (1)

• Patient-reported outcomes measures (PROMs)

  Participants will complete a set of Patient-Reported Outcome Measures (PROMs). Initially, participants will be required to provide several pieces of information, including name, date of birth, gender, residential address, phone number, email address, and date of consultation. Subsequently, participants from all three study groups will respond to ten PROM items assessing various aspects of outcome measures: "I feel pain", "I can move more easily", "I feel strong", "I feel coordinated", "I feel tired", "I can sleep", "I can do activities of daily living", "I can return to work and sports", "I am satisfied with my care", and "I would recommend physical therapy to others". Each item will be rated using a 5-point Likert scale, with response options ranging from 1 (strongly disagree) to 5 (strongly agree). All personal and response data will be treated with strict confidentiality. This interview questioner will take before and after the treatment.

  perioperative

Study Arms (3)

SM A

ACTIVE COMPARATOR

Patients with anterior open bite will wear a 3D direct-printed shape memory clear aligner (SMA) with a horizontal rectangular attachment for about 6-8 months

Device: SMA with attachment

SM

ACTIVE COMPARATOR

Patients with anterior open bite will wear a 3D direct-printed shape memory clear aligner (SMA) without a horizontal rectangular attachment for about 6-8 months

Device: SMA without attachments

CA

ACTIVE COMPARATOR

Patients with anterior open bite will wear a thermoformed conventional clear aligner (CA) with a horizontal rectangular attachment for about 6-8 months

Device: CA with attachment

Interventions

SMA with attachment DEVICE

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

SM A

SMA without attachments DEVICE

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

SM

CA with attachment DEVICE

Thermoformed conventional clear aligner with horizontal rectangular attachment

CA

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-35 years,
• Both genders.
• The patient is well fitted with no systemic disease.
• Mild-moderate dental anterior open bite.
• Well-aligned or mildly crowded dentition.

You may not qualify if:

• Patient with a history of trauma to the molars or incisors.
• Patient with a history of endodontic treatment to the maxillary first molar or incisors.
• Patient with a systemic disease related to bone metabolism.
• Patient taking immunosuppressive drugs or drugs inhibiting or accelerating tooth movement; and
• Patient with neuromuscular deficiencies.

Sponsors & Collaborators

• Kufa University: lead

MeSH Terms

Conditions

Open Bite

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Hasan S. Al-Nuaimi, Ph.D.

CONTACT

+9647711227788; hsh.ortho@yahoo.com

Mamun K. Sujon, Ph.D

CONTACT

00601156867681; mamunkhan@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): March 2, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share