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NCT Number: NCT07273435

Crown Movement in Cases Treated With Direct Printed Aligners

This study aims to evaluate the efficiency of direct 3D printed aligners in achieving the crown movement of upper and lower incisors in patients with spacing during space closure and to compare them with the predicted tooth movements

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University, Banī Suwayf, Egypt

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About this study

This study will be carried out on 23 patients seeking orthodontic treatment at the outpatient orthodontic clinics at the Faculty of Dentistry, Suez Canal, Beni Suef, and British Universities.

The inclusion criteria are: patients aged 18-45 years, with full permanent dentition (excluding third molars), generalized spacing or spacing between anterior teeth, normal skeletal relationships, and Angle Class I or mild Class II malocclusions. Patients with the following criteria will be excluded: patients with missing or extracted permanent teeth (excluding third molars), periodontally compromised teeth, who need any form of hybrid orthodontic treatment (a fixed appliance with aligners), any signs or symptoms of temporomandibular disorders, severe Angle Class II or Class III malocclusions, crowding, and Class II or Class III skeletal discrepancy.

Methods:

  • Intraoral scans will be obtained for the upper and lower arches followed by a 3D simulation before treatment to check the biomechanics and movements of the treatment.
  • After setting up the 3D digital design for treatment, we will begin the fabrication of 3D printed aligners.
  • The patient will be instructed to use the aligner, and instructions will be given to the patient to put aligners in warm water before wearing them. This activates their shape memory allowing them to fit more easily and comfortably, thus reducing stress on the aligners.
  • The Patient will change the aligners every week according to the manufacturer's instructions and at the end of treatment, a new 3D scanning for the patient's dental arches will be taken to obtain the actual model after treatment.
  • The virtual pre-treatment model obtained before, and the actual post-treatment model will be exported as STL files and imported into digital software as virtual pre-treatment and actual post-treatment models.
  • The virtual pre-treatment, virtual and achieved post-treatment models will be superimposed digitally.
  • After superimposition, a 3D coordinate system will be generated for tooth movement measurements. After determining the reference points on the pre-treatment model, they will be transferred onto actual and virtual post-treatment models through tooth crown surface superimposition. The achieved and predicted changes in crown movement of the upper and lower incisors will be calculated.

All numerical data will be collected for statistical analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18- 45 years old.
  • Non- extraction treatment.
  • Angle Class I or Class II dental malocclusion with generalized or localized anterior spacing.
  • Normal probing depth.

Exclusion criteria

  • Active periodontal disease.
  • Crowding cases.
  • Systemic diseases or medications that alter bone metabolism or tooth movement.

Treatment and study plan

Direct printed aligners

Other

Direct printed aligners After intraoral scanning, patients will receive Direct printed aligners, each set will be changed after 10 days, till the patients finish their treatment, then a post intraoral scan will be taken from each patient.

Primary outcomes

  1. Evaluation of the efficacy of direct 3D printed aligners in achieving the planned crown movement of upper and lower incisors ( measured in mm).

    Time frame: 9-12 months

    Compare the achieved crown movements with the predicted crown movements of the upper and lower incisors in spacing cases treated with Directed printed aligners by comparing the pre virtual set up with post treatment set up of the cases using superimposition digital software.

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Khalil, PhD of Orthodontics

CONTACT

[email protected]

Rim M Fathalla, PhD of Orthodontics

CONTACT

[email protected]

00201222726567

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • Beni-Suef University
  • British University In Egypt

Registry information

Official study title

Comparison of Predicted and Achieved Crown Movements in Adult Spacing Cases Treated With 3D Direct-printed Aligners: A Prospective Clinical Trial

Acronym: DPA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.