Crown Movement in Cases Treated With Direct Printed Aligners

NCT ID: NCT07273435

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-07-01

Brief Summary

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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

Detailed Description

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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:

1. 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.
2. After setting up the 3D digital design for treatment, we will begin the fabrication of 3D printed aligners.
3. 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.
4. 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.
5. 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.
6. The virtual pre-treatment, virtual and achieved post-treatment models will be superimposed digitally.
7. 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.

Conditions

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Effect of Direct Printed Aligners on Crown Movement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with spacing

Patients will receive direct printed aligners to treat the spacing

Group Type EXPERIMENTAL

Direct printed aligners

Intervention Type 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.

Interventions

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Direct printed aligners

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role collaborator

British University In Egypt

OTHER

Sponsor Role collaborator

Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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rim fathalla

Rim Mohamed Fathalla Eissa

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rim M Fathalla, PhD of Orthodontics

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

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Beni-Suef University

Banī Suwayf, , Egypt

Site Status RECRUITING

British University in Egypt

Cairo, , Egypt

Site Status RECRUITING

Suez Canal University

Ismailia, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rim M Fathalla, PhD of Orthodontics

Role: CONTACT

00201222726567

Rehab Khalil, PhD of Orthodontics

Role: CONTACT

Facility Contacts

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Rehab M Khalil, PhD of Orthodontics

Role: primary

01005230069

Ahmad Elshennawy, Master of Orthodontics

Role: primary

01003615662

Rim M Fathalla, PhD of Orthodontics

Role: primary

00201222726567

References

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Hertan E, McCray J, Bankhead B, Kim KB. Force profile assessment of direct-printed aligners versus thermoformed aligners and the effects of non-engaged surface patterns. Prog Orthod. 2022 Nov 29;23(1):49. doi: 10.1186/s40510-022-00443-2.

Reference Type RESULT
PMID: 36443390 (View on PubMed)

Lee SY, Kim H, Kim HJ, Chung CJ, Choi YJ, Kim SJ, Cha JY. Thermo-mechanical properties of 3D printed photocurable shape memory resin for clear aligners. Sci Rep. 2022 Apr 15;12(1):6246. doi: 10.1038/s41598-022-09831-4.

Reference Type RESULT
PMID: 35428796 (View on PubMed)

McKay A, McCray J, Bankhead B, Lee MM, Miranda G, Adel SM, Kim KB. Forces and moments generated during extrusion of a maxillary central incisor with clear aligners: an in vitro study. BMC Oral Health. 2023 Jul 17;23(1):495. doi: 10.1186/s12903-023-03136-2.

Reference Type RESULT
PMID: 37461004 (View on PubMed)

Kravitz ND, Kusnoto B, Agran B, Viana G. Influence of attachments and interproximal reduction on the accuracy of canine rotation with Invisalign. A prospective clinical study. Angle Orthod. 2008 Jul;78(4):682-7. doi: 10.2319/0003-3219(2008)078[0682:IOAAIR]2.0.CO;2.

Reference Type RESULT
PMID: 18302468 (View on PubMed)

Weir T. Clear aligners in orthodontic treatment. Aust Dent J. 2017 Mar;62 Suppl 1:58-62. doi: 10.1111/adj.12480.

Reference Type RESULT
PMID: 28297094 (View on PubMed)

Other Identifiers

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#REC-FDBSU/06032025-02/AR

Identifier Type: -

Identifier Source: org_study_id

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