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OpenTrials
Completed

NCT Number: NCT07431333

Shape Memory Orthodontic Aligners

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British university in egypt

Cairo, Egypt

About this study

The aim of many recent interdisciplinary research studies is to introduce novel materials that can play an active role in the appliances. These materials are called smart materials or stimuli-responsive materials which have the ability to react suitably with external stimuli, such as thermal, electrical, or magnetic input, producing a predictable repeatable output. Shape memory materials are subcategory of smart materials which have the ability of changing their macroscopic shape upon a proper stimulus. Unlike shape changing materials, shape memory materials have the capacity to maintain a stable temporary shape until they are appropriately activated to recover their original shape.

Additive manufacturing, also known as 3D printing, dates back to the 1980s and is now reaching a level of maturity where it is now increasingly being used in the fields of both dental and medical modeling. There are multiple applications in oral surgery, prosthodontics, restorative dentistry, orthodontics, implantology and instrument manufacturing. Three-dimensional printing enables the manufacturing of pieces' layer-by-layer instead of common manufacturing methods that rely on machining, molding, and subtractive methods.

-Primary outcomes: Evaluation of the efficiency of both linear and angular tooth movement using directly printed shape memory orthodontic aligners Vs thermoformed shape memory orthodontic aligners (predicted Vs actual tooth movement).

-Secondary outcome: Evaluation of patient's compliance, comfort and color stability via written questionnaire.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

shape memory clear aligners

Device

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

Primary outcomes

  1. The efficiency of both directly printed and thermoformed aligners

    Time frame: from 6 to 8 months

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

Secondary outcomes

  1. compliance

    Time frame: from 6-8 months

    patient compliance will be measured by scoring scale from 1 to 10, 1 represents least compliance - 10 represents highest compliance.

    Minimum compliance is 5 and maximum one is 10

  2. color stability

    Time frame: from 6 to 8 months

    color stability will be measured through patient questionnaire ( yes or no)

  3. aligners comfortability

    Time frame: from 6 to 8 months

    aligners comfortability will be evaluated by patient questionnaire through choosing emoji faces

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

Evaluation of The Efficiency of Directly Printed Shape Memory Vs Thermoformed Shape Memory Orthodontic Aligners

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

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.

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