NCT07273435

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jun 2025

Geographic Reach
1 country

3 active sites

Status
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 Progress87%
Jun 2025Jul 2026

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 19, 2025

Last Update Submit

November 27, 2025

Conditions

Effect of Direct Printed Aligners on Crown Movement

Keywords

Direct printed aligners crown movement

Outcome Measures

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).

    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.

    9-12 months

Study Arms (1)

Patients with spacing

EXPERIMENTAL

Patients will receive direct printed aligners to treat the spacing

Other: Direct printed aligners

Interventions

Direct printed alignersOTHER

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.

Patients with spacing

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beni-Suef University

Banī Suwayf, Egypt

RECRUITING

British University in Egypt

Cairo, Egypt

RECRUITING

Suez Canal University

Ismailia, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 36443390RESULT

  • 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.

    PMID: 35428796RESULT

  • 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.

    PMID: 37461004RESULT

  • 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.

    PMID: 18302468RESULT

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

    PMID: 28297094RESULT

Study Officials

  • Rim M Fathalla, PhD of Orthodontics

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rim M Fathalla, PhD of Orthodontics

CONTACT

00201222726567rim_fathalla@dent.suez.edu.eg

Rehab Khalil, PhD of Orthodontics

CONTACT

rehababdelrazek@dent.bsu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rim Mohamed Fathalla Eissa

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 9, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)