Crowding of Anterior Mandibular TeethNCT07431333
Shape Memory Orthodontic Aligners
A study testing shape memory clear aligners in people with Crowding of Anterior Mandibular Teeth, run by British University In Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- shape memory clear aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Sep 2022to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- shape memory clear aligners
- Keywords
- Directly 3d printed clear aligners, clear aligners, digital orthodontics, lower anterior crowding, shape memory, shape shifting, 4d technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment | Active comparator | Not described Receives: Device: shape memory clear aligners |
| Thermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment | Active comparator | Not described Receives: Device: shape memory clear aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 6 to 8 months
Secondary outcomes (3)
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
Measured: from 6-8 months
color stability
color stability will be measured through patient questionnaire ( yes or no)
Measured: from 6 to 8 months
aligners comfortability
aligners comfortability will be evaluated by patient questionnaire through choosing emoji faces
Measured: from 6 to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start18 Sep 2022
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crowding of Anterior Mandibular TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor
- Investigators
- Islam tarek Hassan, Professor of Orthodontics, Study director, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431333
- Sponsor's protocol ID
- BUEASUPHD
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still thinking about it
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.
PubMed 37656070Elshazly TM, Keilig L, Alkabani Y, Ghoneima A, Abuzayda M, Talaat S, Bourauel CP. Primary Evaluation of Shape Recovery of Orthodontic Aligners Fabricated from Shape Memory Polymer (A Typodont Study). Dent J (Basel). 2021 Mar 10;9(3):31. doi: 10.3390/dj9030031.
PubMed 33801960Tartaglia 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.
PubMed 33916462
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Efficiency of Directly Printed Shape Memory Vs Thermoformed Shape Memory Orthodontic Aligners
- ClinicalTrials.gov ID
- NCT07431333
- Acronym / sponsor ID
- BUEASUPHD
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 18 Sep 2022 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shape memory clear alignersthe 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 | Device | Directly Printed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment, Thermoformed Shape Memory Orthodontic Aligners used in lower anterior crowding treatment |
Primary outcome
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
3 secondary outcomes
compliance
Time frame: from 6-8 months
color stability
Time frame: from 6 to 8 months
aligners comfortability
Time frame: from 6 to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 37656070Spangler 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.
- Background: PubMed 33801960Elshazly TM, Keilig L, Alkabani Y, Ghoneima A, Abuzayda M, Talaat S, Bourauel CP. Primary Evaluation of Shape Recovery of Orthodontic Aligners Fabricated from Shape Memory Polymer (A Typodont Study). Dent J (Basel). 2021 Mar 10;9(3):31. doi: 10.3390/dj9030031.
- Background: PubMed 33916462Tartaglia 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. still thinking about it
Related trials for Crowding of Anterior Mandibular Teeth
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Active, not recruiting
Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study
Malocclusion of Anterior Teeth
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Islam tarek Hassan, Professor of Orthodontics study director
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shape memory clear aligners in people with Crowding of Anterior Mandibular Teeth, run by British University In Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficiency of both directly printed and thermoformed aligners (time frame: from 6 to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07431333, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.