NCT07496892

Brief Summary

The goal of this randomized clinical trial is to compare the accuracy of tooth movement achieved by 3D printed aligners versus thermoformed aligners in patients with lower anterior crowding. The study aims to evaluate whether directly printed aligners provide more accurate and predictable orthodontic tooth movement compared to conventional thermoformed aligners.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

March 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Last Updated

March 27, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

March 17, 2026

Last Update Submit

March 23, 2026

Conditions

Lower Anterior Crowding

Outcome Measures

Primary Outcomes (1)

  • accuracy of tooth movement

    The accuracy of tooth movement will be assessed by comparing the predicted tooth position from the digital treatment plan (TP) with the actual post-treatment position (T1) using 3D superimposition techniques. Measurements will include linear and angular differences for each tooth using digital software analysis.

    6 month

Secondary Outcomes (1)

  • Patient reported Pain

    6 month

Study Arms (2)

3D printed aligner

EXPERIMENTAL

Participants will receive orthodontic treatment using directly 3D printed aligners fabricated with shape memory resin.

Device: 3d printed aligner

thermoformed aligner

ACTIVE COMPARATOR

Participants will receive orthodontic treatment using conventional thermoformed aligners fabricated using vacuum forming techniques.

Device: thermoformed aligner

Interventions

3d printed alignerDEVICE

direct printed aligner will be used

3D printed aligner
thermoformed alignerDEVICE

conventional thermoformed aligner will be the gold standard

thermoformed aligner

Eligibility Criteria

Age11 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non-extraction orthodontic treatment cases
  • Mild to moderate lower anterior crowding (\<5 mm)
  • Age between 12 and 25 years
  • Dental rotation less than 30 degrees
  • Relapse cases with crowding less than 5 mm

You may not qualify if:

  • Active or history of periodontal disease
  • Presence of systemic disease
  • Temporomandibular joint disorders (TMJ)
  • Missing teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, Cairo Governorate, 12613, Egypt

Location

Related Publications (3)

  • Migliorati M et al. Accuracy of orthodontic movements with 3D printed aligners: A prospective observational pilot study. Korean J Orthod. 2024;54(3):160-170.

    BACKGROUND

  • Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernardi CL. Efficacy of clear aligners in controlling orthodontic tooth movement: A systematic review. Angle Orthod. 2015;85(5):881-889.

    BACKGROUND

  • Kesling HD. The philosophy of tooth positioning appliance. Am J Orthod Oral Surg. 1945;31:297-304.

    BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgrade student

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 20, 2026

Last Updated

March 27, 2026

Record last verified: 2025-12

Locations

EG(1)