Lower Anterior CrowdingAlignerNCT07496892
Evaluation of Accuracy of 3D Printed Aligners in Comparison to Thermoformed Aligners in Orthodontic Patients
A study testing 3d printed aligner and thermoformed aligner in people with Lower Anterior Crowding, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to compare the accuracy of tooth movement achieved by 3D printed aligners versus thermoformed aligners in patients with lower anterior crowding. Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- Lower Anterior Crowding
- What is being tested?
- 3d printed aligner and thermoformed aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non-extraction orthodontic treatment cases
- Mild to moderate lower anterior crowding (<5 mm)
- Age between 12 and 25 years
- Dental rotation less than 30 degrees
- Relapse cases with crowding less than 5 mm
Who cannot join
- Active or history of periodontal disease
- Presence of systemic disease
- Temporomandibular joint disorders (TMJ)
- Missing teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Oral and Dental Medicine
Cairo, Cairo Governorate, 12613
Farouk Khaled Ismail, Postgraduate, 00201002487056, farouk.khaled@dentistry.cu.edu.eg
About this study
Official title: Assessment of the Accuracy of Tooth Movement of 3D Printed Versus Thermoformed Aligners in Patients With Lower Anterior Crowding: A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare the accuracy of tooth movement achieved by 3D printed aligners versus thermoformed aligners in patients with lower anterior crowding. The study aims to evaluate whether directly printed aligners provide more accurate and predictable orthodontic tooth movement compared to conventional thermoformed aligners.
Read the detailed description
Recently, a new resin for 3D direct printed aligners (DPA) has been introduced. This resin, characterized by its viscoelastic properties, allows for precise control over material dimensions, structure, and properties. This enables the aligners to exert constant and gradual forces within the physiological limits of tooth movements .
Tera Harz Tc-58, a new direct-printed resin material introduced by Graphy Company, exhibits a significant shape memory effect. Approximately 90% of the deformation is recovered within 10 minutes, while 96% recovered after 60 minutes, whereas PETG maintains its deformed shape and shows no shape recovery.
DPA shows a significant enhancement in treating different moderate malocclusion cases by reducing the peer assessment rating (PAR) score by 86% and also reducing the need for attachment which simplifies treatment.
This study aims to determine the accuracy of DPA in facilitating tooth movement and to identify which types of tooth movements are more accurately achieved with DPA compared to conventional aligners.
- Conditions
- Lower Anterior Crowding
- Being tested
- 3d printed aligner, thermoformed aligner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed alignerDevice
direct printed aligner will be used
thermoformed alignerDevice
conventional thermoformed aligner will be the gold standard
| Study group | Role | What they receive |
|---|---|---|
| 3D printed aligner | Experimental | Participants will receive orthodontic treatment using directly 3D printed aligners fabricated with shape memory resin. Receives: Device: 3d printed aligner |
| thermoformed aligner | Active comparator | Participants will receive orthodontic treatment using conventional thermoformed aligners fabricated using vacuum forming techniques. Receives: Device: thermoformed aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of tooth movement
The accuracy of tooth movement will be assessed by comparing the predicted tooth position from the digital treatment plan (TP) with the actual post-treatment position (T1) using 3D superimposition techniques. Measurements will include linear and angular differences for each tooth using digital software analysis.
Measured: 6 month
Secondary outcomes (1)
Patient reported Pain
Pain levels will be evaluated using a Visual Analogue Scale questionnaire completed by participants during aligner therapy.
its score from 1 to 10 in which score 10 is the worst pain level
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
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 Lower Anterior CrowdingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farouk Khaled, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496892
- Sponsor's protocol ID
- 30-12-2025
- Acronym
- Aligner
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data is currently under consideration. Any data sharing will comply with institutional policies and participant confidentiality requirements.
Publications
Migliorati M, Drago S, Castroflorio T, Pesce P, Battista G, Campobasso A, Gastaldi G, Valvecchi FF, Mari A. Accuracy of orthodontic movements with 3D printed aligners: A prospective observational pilot study. Korean J Orthod. 2024 May 25;54(3):160-170. doi: 10.4041/kjod23.268. Epub 2024 Apr 8.
PubMed 38800861Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernardi CL. Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. Angle Orthod. 2015 Sep;85(5):881-9. doi: 10.2319/061614-436.1. Epub 2014 Nov 20.
PubMed 25412265Kesling HD. The philosophy of tooth positioning appliance. Am J Orthod Oral Surg. 1945;31:297-304.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of Tooth Movement of 3D Printed Versus Thermoformed Aligners in Patients With Lower Anterior Crowding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07496892
- Acronym / sponsor ID
- Aligner / 30-12-2025
- Conditions
- Lower Anterior Crowding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 27 Mar 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.
The goal of this randomized clinical trial is to compare the accuracy of tooth movement achieved by 3D printed aligners versus thermoformed aligners in patients with lower anterior crowding. The study aims to evaluate whether directly printed aligners provide more accurate and predictable orthodontic tooth movement compared to conventional thermoformed aligners.
Detailed description
Recently, a new resin for 3D direct printed aligners (DPA) has been introduced. This resin, characterized by its viscoelastic properties, allows for precise control over material dimensions, structure, and properties. This enables the aligners to exert constant and gradual forces within the physiological limits of tooth movements .
Tera Harz Tc-58, a new direct-printed resin material introduced by Graphy Company, exhibits a significant shape memory effect. Approximately 90% of the deformation is recovered within 10 minutes, while 96% recovered after 60 minutes, whereas PETG maintains its deformed shape and shows no shape recovery.
DPA shows a significant enhancement in treating different moderate malocclusion cases by reducing the peer assessment rating (PAR) score by 86% and also reducing the need for attachment which simplifies treatment.
This study aims to determine the accuracy of DPA in facilitating tooth movement and to identify which types of tooth movements are more accurately achieved with DPA compared to conventional aligners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed aligner | Experimental | Device: 3d printed alignerParticipants will receive orthodontic treatment using directly 3D printed aligners fabricated with shape memory resin. |
| thermoformed aligner | Active comparator | Device: thermoformed alignerParticipants will receive orthodontic treatment using conventional thermoformed aligners fabricated using vacuum forming techniques. |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Non-extraction orthodontic treatment cases
- Mild to moderate lower anterior crowding (<5 mm)
- Age between 12 and 25 years
- Dental rotation less than 30 degrees
- Relapse cases with crowding less than 5 mm
Key exclusion criteria (4 listed)
- Active or history of periodontal disease
- Presence of systemic disease
- Temporomandibular joint disorders (TMJ)
- Missing 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 |
|---|---|---|
| 3d printed alignerdirect printed aligner will be used | Device | 3D printed aligner |
| thermoformed alignerconventional thermoformed aligner will be the gold standard | Device | thermoformed aligner |
Primary outcome
accuracy of tooth movement
Time frame: 6 month
The accuracy of tooth movement will be assessed by comparing the predicted tooth position from the digital treatment plan (TP) with the actual post-treatment position (T1) using 3D superimposition techniques. Measurements will include linear and angular differences for each tooth using digital software analysis.
1 secondary outcome
Patient reported Pain
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 38800861Migliorati M, Drago S, Castroflorio T, Pesce P, Battista G, Campobasso A, Gastaldi G, Valvecchi FF, Mari A. Accuracy of orthodontic movements with 3D printed aligners: A prospective observational pilot study. Korean J Orthod. 2024 May 25;54(3):160-170. doi: 10.4041/kjod23.268. Epub 2024 Apr 8.
- Background: PubMed 25412265Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernardi CL. Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. Angle Orthod. 2015 Sep;85(5):881-9. doi: 10.2319/061614-436.1. Epub 2014 Nov 20.
- BackgroundKesling HD. The philosophy of tooth positioning appliance. Am J Orthod Oral Surg. 1945;31:297-304.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data is currently under consideration. Any data sharing will comply with institutional policies and participant confidentiality requirements.
Related trials for Lower Anterior Crowding
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
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 Micro-osteoperforations on Lower Anterior Crowding Using Clear Aligners
Mandibular Dental Crowding
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printed aligner and thermoformed aligner in people with Lower Anterior Crowding, run by Cairo University 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 5 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: opening soon, as of the sponsor's last update on 27 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of tooth movement (time frame: 6 month). 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 NCT07496892, 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 27 Mar 2026.