Angle Class I MalocclusionNCT07637227
Clinical Performance of Direct-Printed Versus Thermoformed Aligners
A study testing Direct-Printed Aligner and Thermoformed aligner in people with Angle Class I Malocclusion and Dental Crowding, run by University of Baghdad at 3 sites in Iraq.
Trial summary
The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Angle Class I Malocclusion, Dental Crowding, Tooth Spacing
- What is being tested?
- Direct-Printed Aligner and Thermoformed aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesIraq
- Study dates
- Jun 2026to Oct 2027
- Phase
- Interventional
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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult patient with an age range of 15-30 with fully erupted all permanent dentitions excluding third molars, and a willingness to participate in the trial.
- Angle Class I non-extraction cases, presented with mild crowding or spacing (<5 mm) and dental rotation <30° .
- Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption.
Who cannot join
- Pregnancy, smoking, and systemic conditions affecting bone remodeling.
- Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene \& Vermillion, 1963).
- Patient with malposed lower second molars (need orthodontic alignment).
- Allergy to materials used (resins, plastics, solvents).
- History of trauma, root resorption, and dilacerated roots.
- Previous extraction or history of previous orthodontic treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq3 sites, 3 recruiting
- Recruiting
Specialized Dental Center for Prosthodontics and Orthodontics
Baghdad, Bab Al-Muadham, 10047
Ali Rahman Issa, 009647801218939, ali.hassan1902@codental.uobaghdad.edu.iq
- Recruiting
Z Orchida Clinic
Baghdad, 10013
Ali Rahman isaa, 009647801218939, ali.abdolrahman@gmail.com
- Recruiting
Orthodontic department, College of dentistry, university of Baghdad.
Baghdad, 10047
Ali Rahman Issa, PhD. student, 009647801218939, ali.hassan1902@codental.uobaghdad.edu.iq
About this study
Official title: Clinical Performance of In-Office Directly Printed Versus Thermoformed Aligners: A Randomized Clinical Trial
The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners.
The main question it aims to answer is:
Read more
Does the use of in-office direct-printed shape-memory aligners result in superior clinical effectiveness, compared to established multilayer thermoformed aligner systems?
Researchers will compare a Direct-Printed Aligner (DPA) group using Senertek Clear-A V2 resin to a Thermoformed Aligner (TFA) group using Zendura FLX multilayer sheets to see if the additive manufacturing process improves clinical outcomes and patient satisfaction.
Participants will:
- Undergo initial records including intraoral digital scans, photos, and a panoramic radiograph for treatment planning.
- Wear their assigned clear aligners (either direct-printed or thermoformed) for at least 22 hours per day, changing them every 7 days.
- Attend follow-up appointments every 5 weeks.
Read the detailed description
This is a prospective, parallel-arm randomized controlled multi-center clinical trial, to assess and compare the clinical effectiveness of in-office 3D-printed clear aligners with multilayered thermoformed aligners.
The subject population for this study will be male and female subjects aged 16-30 years who have fully erupted permanent dentition and mild dental crowding or spacing.
Methodology:
Patients requiring orthodontic treatment are randomly allocated into two groups.
Experimental Group (DPA): Aligners are fabricated using additive manufacturing (direct 3D printing) with Senertek Clear-A V2 shape-memory resin. This process eliminates the intermediate physical model, potentially reducing cumulative manufacturing errors.
Control Group (TFA): Aligners are fabricated by thermoforming multilayered thermoplastic sheets (Zendura FLX) over 3D-printed resin molds.
Assessment:
Digital models (STL files) will be obtained at the start (T0) and at the end of the treatment (T1). These will be compared to the digital treatment plan (Tp) using 3D superimposition and trigonometric analysis. Stable anatomical structures, such as the palatal rugae, will serve as reference points for superimposition. The primary outcome is the "Tracking Accuracy Percentage," which measures how closely the actual clinical tooth movement matches the digitally predicted movement. Secondary outcomes include clinical efficiency, patient-reported pain levels, and Manufacturing complexity, including total fabrication time.
- Conditions
- Angle Class I Malocclusion, Dental Crowding, Tooth Spacing
- Being tested
- Direct-Printed Aligner, Thermoformed aligner
- Keywords
- In office aligners, 3D printed aligners, Thermoformed Aligners, Tooth movement, Photopolymer Resin, Pain
- Medical subject headings
- Malocclusion, Angle Class I, Crowding, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct-Printed AlignerDevice
Participants in this group will receive clear aligner therapy fabricated via direct-printing, utilizing a specialized light-curable resin (Clear-A V2, Senertek, İzmir, Turkey).
Thermoformed alignerDevice
Participants in this group will treated with clear aligners fabricated via the conventional indirect method, involving the thermoforming of thermoplastic sheets (Zendura FLX, Zendura dental, Fremont, California) over 3D-printed dental molds.
| Study group | Role | What they receive |
|---|---|---|
| Direct-Printed Aligner | Experimental | Participants in this group will receive clear aligners manufactured using in-office 3D printing technology. This arm tests the effectiveness of additive manufacturing and the shape-memory properties of the resin in achieving programmed tooth movements. Receives: Device: Direct-Printed Aligner |
| Thermoformed Aligner | Active comparator | Participants in this group will receive conventional clear aligners manufactured using the vacuum-forming (thermoforming) process. This arm serves as the gold standard to which the experimental 3D-printed aligners are compared. Receives: Device: Thermoformed aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular tooth movement tracking accuracy
Digital models (Initial (T0), planned (Tp), and final (T1)) will be compared using trigonometry. Angular measurements of vestibulo-lingual tipping, mesio-distal tipping, and rotation, will be performed on the three digital casts that had been previously superimposed.
Measured: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Linear tooth movement tracking accuracy
Evaluation of the tracking accuracy of linear tooth movements (in millimeters) by superimposing three-dimensional digital dental models across three therapeutic stages: Initial (T0), Planned (Tp), and Final (T1). Trigonometric spatial analysis will be executed on the superimposed digital casts to quantify the absolute positional discrepancy between the virtually planned tooth position and the actual clinically achieved position.
Measured: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Secondary outcomes (6)
Clinical efficiency
The additional treatment time necessitated by refinements will be calculated and compared statistically between the study groups.
Measured: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Evaluate degree of conversion
The relative concentration of unreacted aliphatic carbon double bonds will be evaluated by measuring the peak areas of the aliphatic C=C stretching vibrations (at 1634 cm -1 and 1620 cm-1) and the stable internal standard (N-H bending absorption at 1523 cm-1) via the tangent baseline technique. These distinct spectral values will be mathematically aggregated using the standard normalized ratio equation: DC (%)=[1-(R cured/R monomer)]×100. Unit of Measure, percentage (%) of converted double bonds.
Measured: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Shape memory property
The percentage of shape recovery over time and the total deformation angles exhibited by both the direct-printed resin (Senertek Clear-A V2) and the thermoformed aligner sheets.Quantitative measurements will be recorded using a standardized thermo-mechanical bending test layout under controlled temperature intervals.
Measured: 3 months
Color stability assessment
Optical transmittance will be measured across the visible light spectrum to evaluate and compare the transparency degradation and color stability of direct-printed versus thermoformed aligners before and after in vivo aging.
Measured: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Manufacturing complexity and fabrication time
For each workflow, the total production time, hands-on labor, and material expenses will be recorded and analyzed.
Measured: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Patient-Reported Treatment Discomfort
Patient-reported pain or discomfort evaluated on a standard horizontal Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain). Unit of Measure, millimeters (mm) on a 100 mm scale.
Measured: The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class I MalocclusionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Rahman Issa, University of Baghdad
- Investigators
- Noor Muhammed Garma, Assistant Professor, Study director, University of Baghdad, College of Dentistry, Department of Orthodontic.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637227
- Sponsor's protocol ID
- 1197426
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No