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Shape Memory Orthodontic Aligners

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07431333
Enrollment
16
Registered
2026-02-24
Start date
2022-09-18
Completion date
2025-03-15
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

Directly 3d printed clear aligners, clear aligners, digital orthodontics, lower anterior crowding, shape memory, shape shifting, 4d technology

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.

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.

Interventions

DEVICEshape 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

Sponsors

British University In Egypt
Lead SponsorOTHER
Ain Shams University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The efficiency of both directly printed and thermoformed alignersfrom 6 to 8 monthsthe relief of mandibular anterior teeth crowding per duration of treatment measured in millimeters per total months

Secondary

MeasureTime frameDescription
compliancefrom 6-8 monthspatient 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
color stabilityfrom 6 to 8 monthscolor stability will be measured through patient questionnaire ( yes or no)
aligners comfortabilityfrom 6 to 8 monthsaligners comfortability will be evaluated by patient questionnaire through choosing emoji faces

Countries

Egypt

Contacts

STUDY_DIRECTORIslam tarek Hassan, Professor of Orthodontics

British University In Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026