NCT07431333

Brief Summary

Innovative recent materials are trying to achieve the most of orthodontic movements using the least number of aligner, also trying to reduce the manufacturing steps combined by enhancing the accuracy of each aligner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 18, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

April 8, 2025

Last Update Submit

February 23, 2026

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

Directly 3d printed clear alignersclear alignersdigital orthodonticslower anterior crowdingshape memoryshape shifting4d technology

Outcome Measures

Primary Outcomes (1)

  • The efficiency of both directly printed and thermoformed aligners

    the relief of mandibular anterior teeth crowding per duration of treatment measured in millimeters per total months

    from 6 to 8 months

Secondary Outcomes (3)

  • compliance

    from 6-8 months

  • color stability

    from 6 to 8 months

  • aligners comfortability

    from 6 to 8 months

Study Arms (2)

Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment

ACTIVE COMPARATOR
Device: shape memory clear aligners

Thermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment

ACTIVE COMPARATOR
Device: shape memory clear aligners

Interventions

shape memory clear alignersDEVICE

the usage of shape memory thermoformed clear aligners and the shape memory directly 3d printed clear aligners helps to achieve more biologic tooth movement for the patients

Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatmentThermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Crowding in lower anterior teeth ranging from 4 to 6 mm.
  • Participants whose treatment plan need lower anterior teeth alignment.
  • Presence of permanent teeth except for lower premolar extraction performed for orthodontic purposes.
  • Participants who need orthodontic treatment after relapse in lower anterior teeth take place one-year post retention.

You may not qualify if:

  • Active systemic diseases that affect tooth movement (e.g. osteoporosis, bisphosphonate therapy, etc...).
  • Patients with biting habits (clinching, bruxism, etc…)
  • Patients with bad oral hygiene or high caries index or periodontal inflammation or gingival recession.
  • Presence of active labial caries or class V restorations or enamel hypoplasia in lower anterior teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British university in egypt

Cairo, Egypt

Location

Related Publications (3)

  • Spangler T, Ammoun R, Carrico CK, Bencharit S, Tufekci E. The effect of crowding on the accuracy of 3-dimensional printing. Am J Orthod Dentofacial Orthop. 2023 Dec;164(6):879-888. doi: 10.1016/j.ajodo.2023.08.005. Epub 2023 Sep 1.

    PMID: 37656070BACKGROUND

  • Elshazly, T. M. et al. Primary evaluation of shape recovery of orthodontic aligners fabricated from shape memory polymer (A typodont study). Dent. J. 9, (2021).

    BACKGROUND

  • Tartaglia, G. M. et al. Direct 3D printing of clear orthodontic aligners: Current state and future possibilities. Materials 14, (2021).

    BACKGROUND

Related Links

Study Officials

  • Islam tarek Hassan, Professor of Orthodontics

    British University In Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

February 24, 2026

Study Start

September 18, 2022

Primary Completion

March 15, 2025

Study Completion

March 15, 2025

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

EG(1)