Class I MalocclusionNCT07350343
The Predictability of Directly Printed Versus Thermoformed Clear Aligners
A study testing Direct-printed aligner (Graphy) and Thermoformed aligner in people with Class I Malocclusion and Crowded Teeth, run by University of Baghdad at 1 site in Iraq.
Trial summary
The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between actual and predicted dental movement in patients treated using direct printed aligners produced with Graphy™ Tera Harz TA-28 resin as compared to those treated with thermoformed clear aligners. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Class I Malocclusion, Crowded Teeth, Spacing of Anterior Teeth
- What is being tested?
- Direct-printed aligner (Graphy) and Thermoformed aligner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIraq
- Study dates
- 15 Feb 2026to 1 Jun 2027
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with mild to moderate malocclusion that can be treated by less than 40 steps of aligner treatment, including those with dental rotation of < 30°, diastema or crowding of < 8 mm.
- Patients aged ≥ 16 years with fully erupted permanent teeth (regardless of the third molar).
- No supernumerary teeth, no enamel malformation.
- No tooth shape anomalies
Who cannot join
- Systemic pathologies such as uncontrolled diabetes or heart diseases
- active or past periodontal disease
- previous orthodontic treatment
- temporomandibular joint disorders
- ongoing pharmacological treatment could influence orthodontic treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
The sample will be recruited from multicentre clinics (Private dental clinic, Orthodontic Department at Karbala Governmental Specialized Dental Centre, Orthodontic Department, College of Dentistry University of Baghdad).
Karbala
About this study
Official title: The Predictability of Directly Printed Shape Memory (Graphy) Versus Thermoformed Clear Aligners: A Randomized Clinical Trial
The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between actual and predicted dental movement in patients treated using direct printed aligners produced with Graphy™ Tera Harz TA-28 resin as compared to those treated with thermoformed clear aligners.
Read the detailed description
the patients will be randomly assigned to one of two study groups which either direct printed or thermoformed clear aligner. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.Teeth positions would be planned according to esthetic and functional principles, starting with the 3D T0 digital model and aligning and leveling dental arches following orthodontic aligner biomechanical principles. Each aligner had a planned movement speed of 0.2 mm linear displacement, 2° long-axis rotation, and a vestibulo-lingual inclination of 2.5°.
- Being tested
- Direct-printed aligner (Graphy), Thermoformed aligner
- Keywords
- direct printed graphy... thermoform
- Medical subject headings
- Malocclusion, Angle Class I, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct-printed aligner (Graphy)Device
intraoral scanner would be used to scan patient teeth then aligner fabrication by direct printing then the patient will be treated with direct-printed aligners(graphy) until dental levelling alignment; space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.
Thermoformed alignerDevice
An intraoral scanner would be used to scan patient teeth then aligner fabrication by thermoforming then the Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Direct-printed aligner (Graphy) | Experimental | Patients will be treated with direct-printed Graphy aligners until dental levelling alignment; space closure is finished. Receives: Device: Direct-printed aligner (Graphy) |
| Thermoformed aligner | Active comparator | Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished. Receives: Device: Thermoformed aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictability of tooth movement
The primary outcome will be calculated as the percentage difference between the final and initial positions for each individual tooth movement assessed and will be expressed as a continuous numerical variable representing tooth movement predictability (%).
Measured: 12 months
Secondary outcomes (4)
predictability within different types
- The secondary outcome will be assessed by comparing the predictability within different types of tooth movement of the same group.
Measured: 12 months
Colour change of clear aligners
UV-Visible spectrophotometer for samples from both groups before and after intraoral aging.
Measured: 12 months
Degree of Conversion
Assessment of the Degree of Conversion of direct printed Tera Harz TA-28 resin using Fourier-transform infrared (FTIR) spectroscopy for the liquid resin before curing and for samples after curing and post-processing.
Measured: 12 months
shape memory effect
Assessment of the shape memory effect of direct printed Tera Harz TA-28 aligners, the bending test would be used to investigate and directly visualize the shape recovery property.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Feb 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class I MalocclusionStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussin Anwar, University of Baghdad
- Investigators
- hussin anwar, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350343
- Sponsor's protocol ID
- 1154425
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictability of Directly Printed Shape Memory (Graphy) Versus Thermoformed Clear Aligners: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07350343
- Acronym / sponsor ID
- 1154425
- Keywords
- direct printed graphy... thermoform
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Jan 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 study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between actual and predicted dental movement in patients treated using direct printed aligners produced with Graphy™ Tera Harz TA-28 resin as compared to those treated with thermoformed clear aligners.
Detailed description
the patients will be randomly assigned to one of two study groups which either direct printed or thermoformed clear aligner. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.Teeth positions would be planned according to esthetic and functional principles, starting with the 3D T0 digital model and aligning and leveling dental arches following orthodontic aligner biomechanical principles. Each aligner had a planned movement speed of 0.2 mm linear displacement, 2° long-axis rotation, and a vestibulo-lingual inclination of 2.5°.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct-printed aligner (Graphy) | Experimental | Device: Direct-printed aligner (Graphy)Patients will be treated with direct-printed Graphy aligners until dental levelling alignment; space closure is finished. |
| Thermoformed aligner | Active comparator | Device: Thermoformed alignerPatients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with mild to moderate malocclusion that can be treated by less than 40 steps of aligner treatment, including those with dental rotation of < 30°, diastema or crowding of < 8 mm.
- Patients aged ≥ 16 years with fully erupted permanent teeth (regardless of the third molar).
- No supernumerary teeth, no enamel malformation.
- No tooth shape anomalies
Key exclusion criteria (5 listed)
- Systemic pathologies such as uncontrolled diabetes or heart diseases
- active or past periodontal disease
- previous orthodontic treatment
- temporomandibular joint disorders
- ongoing pharmacological treatment could influence orthodontic treatment.
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 |
|---|---|---|
| Direct-printed aligner (Graphy)intraoral scanner would be used to scan patient teeth then aligner fabrication by direct printing then the patient will be treated with direct-printed aligners(graphy) until dental levelling alignment; space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days. | Device | Direct-printed aligner (Graphy) |
| Thermoformed alignerAn intraoral scanner would be used to scan patient teeth then aligner fabrication by thermoforming then the Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days. | Device | Thermoformed aligner |
Primary outcome
predictability of tooth movement
Time frame: 12 months
The primary outcome will be calculated as the percentage difference between the final and initial positions for each individual tooth movement assessed and will be expressed as a continuous numerical variable representing tooth movement predictability (%).
4 secondary outcomes
predictability within different types
Time frame: 12 months
Colour change of clear aligners
Time frame: 12 months
Degree of Conversion
Time frame: 12 months
shape memory effect
Time frame: 12 months
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 15 Apr 2026.
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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.
hussin anwar principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct-printed aligner (Graphy) and Thermoformed aligner in people with Class I Malocclusion and Crowded Teeth, run by University of Baghdad at 1 site in Iraq.
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 5 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: enrolling by invitation, as of the sponsor's last update on 15 Apr 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 Iraq. 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?
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?
predictability of tooth movement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.