Shape Memory Orthodontic Aligners

Evaluation of The Efficiency of Directly Printed Shape Memory Vs Thermoformed 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.

Study Overview

• Status: Completed
• Conditions: Crowding of Anterior Mandibular Teeth
• Intervention / Treatment: Device: shape memory clear aligners

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • British University In Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment	Device: shape memory clear aligners; 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
Active Comparator: Thermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment	Device: shape memory clear aligners; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance	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	from 6-8 months
color stability	color stability will be measured through patient questionnaire ( yes or no)	from 6 to 8 months
aligners comfortability	aligners comfortability will be evaluated by patient questionnaire through choosing emoji faces	from 6 to 8 months

Collaborators and Investigators

• Sponsor: British University In Egypt
• Collaborators: Ain Shams University
• Investigators: Study Director: Islam tarek Hassan, Professor of Orthodontics, British University In Egypt

Publications and helpful links

General Publications

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

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2022
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lower anterior crowding; clear aligners; shape memory; digital orthodontics; Directly 3d printed clear aligners; shape shifting; 4d technology
• Other Study ID Numbers: BUEASUPHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: still thinking about it

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No