NCT07273552

Brief Summary

This study aims to three-dimensionally evaluate the efficiency of direct 3D printed aligners in achieving the planned root torque by using CBCT and to assess the associated bone thickness changes and root resorption.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
14

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 Root Torque

Keywords

Direct printed aligners torque

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors .

    9-12 months

Secondary Outcomes (2)

  • Change in the bone thickness (measured in mm) around the upper and lower incisors associated with the achieved root torque.

    9-12 months

  • Assessment of amount of root resorption (measured in mm) of upper and lower incisors associated with root torque.

    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

After intraoral scanning and CBCT taking, patients will receive Direct printed aligners, each set will be changed after 10 days, till the patients finish their treatment, then a post-CBCT 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 (6)

  • Iglesias-Linares A, Sonnenberg B, Solano B, Yanez-Vico RM, Solano E, Lindauer SJ, Flores-Mir C. Orthodontically induced external apical root resorption in patients treated with fixed appliances vs removable aligners. Angle Orthod. 2017 Jan;87(1):3-10. doi: 10.2319/02016-101.1. Epub 2016 Aug 9.

    PMID: 27504821RESULT

  • Li Y, Deng S, Mei L, Li Z, Zhang X, Yang C, Li Y. Prevalence and severity of apical root resorption during orthodontic treatment with clear aligners and fixed appliances: a cone beam computed tomography study. Prog Orthod. 2020 Jan 6;21(1):1. doi: 10.1186/s40510-019-0301-1.

    PMID: 31903505RESULT

  • Lacruz RS, de Castro JM, Martinon-Torres M, O'Higgins P, Paine ML, Carbonell E, Arsuaga JL, Bromage TG. Facial morphogenesis of the earliest europeans. PLoS One. 2013 Jun 6;8(6):e65199. doi: 10.1371/journal.pone.0065199. Print 2013.

    PMID: 23762314RESULT

  • Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.

    PMID: 26629473RESULT

  • Sfondrini MF, Gandini P, Castroflorio T, Garino F, Mergati L, D'Anca K, Trovati F, Scribante A. Buccolingual Inclination Control of Upper Central Incisors of Aligners: A Comparison with Conventional and Self-Ligating Brackets. Biomed Res Int. 2018 Nov 29;2018:9341821. doi: 10.1155/2018/9341821. eCollection 2018.

    PMID: 30627583RESULT

  • Tartaglia GM, Mapelli A, Maspero C, Santaniello T, Serafin M, Farronato M, Caprioglio A. Direct 3D Printing of Clear Orthodontic Aligners: Current State and Future Possibilities. Materials (Basel). 2021 Apr 5;14(7):1799. doi: 10.3390/ma14071799.

    PMID: 33916462RESULT

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

00201005230669rehababdelrazek@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)