Malocclusion, Angle Class INCT07687329
Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic Treatment
A study testing Direct In-House Clear Aligners, Indirect In-House Clear Aligners and Fixed Orthodontic Appliances in people with Malocclusion, Angle Class I, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Clear aligner therapy has become increasingly popular as an esthetic alternative to conventional braces in orthodontic treatment. While clear aligners are traditionally manufactured by commercial laboratories using a thermoforming technique, recent advances in 3D printing technology now allow clinicians to produce… Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Malocclusion, Angle Class I
- What is being tested?
- Direct In-House Clear Aligners, Indirect In-House Clear Aligners and Fixed Orthodontic Appliances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of permanent dentition (no primary teeth remaining)
- Non-extraction orthodontic treatment plan
- Age between 12 and 30 years
- Mild to moderate dental crowding (0-6 mm)
- Skeletal Class I classification (ANB: 2±2°)
- Normal vertical growth direction (Sn-GoGn: 32±6°)
Show all 12Show fewer
- No congenital tooth agenesis (excluding third molars)
- No atypical tooth shapes
- No extracted permanent teeth
- No dental caries
- Good oral hygiene
- Healthy periodontal tissues
Who cannot join
- Presence of craniofacial anomalies
- Systemic disease or condition
- Previous fixed orthodontic treatment
- History of allergy to dental materials
- History of xerostomia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University, Faculty of Dentistry, Department of Orthodontics
Kayseri, Melikgazi
About this study
Official title: Comparison Of Efficiency And Treatment Duration Between Clear Aligners Manufactured Directly And Indirectly By The Clinician And Fixed Orthodontic Treatment: An In Vivo Randomized Clinical Trial
Clear aligner therapy has become increasingly popular as an esthetic alternative to conventional braces in orthodontic treatment. While clear aligners are traditionally manufactured by commercial laboratories using a thermoforming technique, recent advances in 3D printing technology now allow clinicians to produce aligners directly in their own clinic, either by printing the aligner itself (direct method) or by printing a model and then thermoforming the aligner over it (indirect method)." "This study compares three approaches to orthodontic treatment in patients with mild to moderate dental crowding who do not require tooth extraction: clear aligners produced directly in-house using 3D printing with a shape-memory resin, clear aligners produced indirectly in-house using a 3D-printed model and thermoforming, and conventional fixed orthodontic treatment with metal brackets and wires." "A total of 36 patients aged 12 to 30 years were randomly assigned to one of these three treatment groups, and 33 patients completed the study. Treatment quality was evaluated using the American Board of Orthodontics Objective Grading System (ABO-OGS), an objective scoring method based on dental models obtained at the end of treatment. The total duration of treatment, from the start of active treatment to its completion, was also compared among the three groups." "The findings of this study may help clinicians and patients better understand the advantages and limitations of in-house clear aligner production compared to conventional fixed appliances, particularly regarding treatment efficiency and duration.
- Conditions
- Malocclusion, Angle Class I
- Being tested
- Direct In-House Clear Aligners, Indirect In-House Clear Aligners, Fixed Orthodontic Appliances
- Keywords
- Clear aligners, Fixed orthodontic appliance, 3D Printing, In-House Aligners, Orthodontic Treatmen Duration, ABO Objective Grading System
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct In-House Clear AlignersDevice
Clear aligners fabricated directly by the clinician using a stereolithography (SLA) 3D printer (Asiga MAX UV) with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea). The shell of the aligner was designed digitally using Direct Aligner Designer software and printed directly, without the need for a physical model. Printed aligners were post-processed by centrifugation to remove excess resin, followed by UV light curing.
Indirect In-House Clear AlignersDevice
Clear aligners fabricated indirectly by the clinician via 3D-printed dental models (Asiga MAX UV printer) followed by thermoforming using CA Pro+ sheets (0.75 x 120 mm, SCHEU-DENTAL GmbH, Iserlohn, Germany) with a pressure-forming machine (MINISTAR S). The thermoformed aligners were trimmed from the printed model after shaping.
Fixed Orthodontic AppliancesDevice
Conventional fixed orthodontic treatment using metal brackets (AO, Mini Master Roth 018, ) bonded to the upper and lower dental arches with stainless steel archwires.
| Study group | Role | What they receive |
|---|---|---|
| Group A ( Direct - In-House) | Experimental | Participants received clear aligners manufactured directly by the clinician using 3D printing with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea). Receives: Device: Direct In-House Clear Aligners |
| Group B ( Indirect - In-House) | Experimental | Participants received clear aligners manufactured indirectly by the clinician via 3D-printed models followed by thermoforming with CA Pro+ sheets (SCHEU-DENTAL GmbH, Iserlohn, Germany). Receives: Device: Indirect In-House Clear Aligners |
| Group C (Fixed Orthodontic Treatment) | Active comparator | Participants received conventional fixed orthodontic treatment with metal brackets (AO Mini Master Roth 018). Receives: Device: Fixed Orthodontic Appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS)
Post-treatment dental models were evaluated using the ABO Objective Grading System, which scores eight criteria: tooth alignment, marginal ridge height, buccolingual inclination, overjet, occlusal contacts, occlusal relationships, interproximal contacts, and root angulation. Lower total scores indicate better treatment quality. Scores were classified as successful (<20), borderline (20-30), or unsuccessful (>30).
Measured: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months
Secondary outcomes (1)
Total Treatment Duration
The total duration of treatment was calculated as the time interval between treatment initiation (aligner delivery or bracket bonding) and treatment completion (final day of aligner use or bracket debonding)
Measured: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start15 Feb 2024
- 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.
- Other trials for Malocclusion, Angle Class IStudies 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
- Model description
- Participants were randomly assigned to one of three parallel groups: direct in-house clear aligners, indirect in-house clear aligners, or fixed orthodontic treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ahmet Yağcı, TC Erciyes University
- Investigators
- Ahmet Yağcı, Prof. Dr., Principal investigator, Erciyes University, Faculty of Dentistry, Department of OrthodonticsMusa Göksu, DDS, Study director, Erciyes University, Faculty of Dentistry, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687329
- Sponsor's protocol ID
- TDH-2024-14031
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Efficiency And Treatment Duration Between Clear Aligners Manufactured Directly And Indirectly By The Clinician And Fixed Orthodontic Treatment: An In Vivo Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07687329
- Acronym / sponsor ID
- TDH-2024-14031
- Conditions
- Malocclusion, Angle Class I
- Keywords
- Clear aligners, Fixed orthodontic appliance, 3D Printing, In-House Aligners, Orthodontic Treatmen Duration, ABO Objective Grading System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 7 Jul 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.
Clear aligner therapy has become increasingly popular as an esthetic alternative to conventional braces in orthodontic treatment. While clear aligners are traditionally manufactured by commercial laboratories using a thermoforming technique, recent advances in 3D printing technology now allow clinicians to produce aligners directly in their own clinic, either by printing the aligner itself (direct method) or by printing a model and then thermoforming the aligner over it (indirect method)." "This study compares three approaches to orthodontic treatment in patients with mild to moderate dental crowding who do not require tooth extraction: clear aligners produced directly in-house using 3D printing with a shape-memory resin, clear aligners produced indirectly in-house using a 3D-printed model and thermoforming, and conventional fixed orthodontic treatment with metal brackets and wires." "A total of 36 patients aged 12 to 30 years were randomly assigned to one of these three treatment groups, and 33 patients completed the study. Treatment quality was evaluated using the American Board of Orthodontics Objective Grading System (ABO-OGS), an objective scoring method based on dental models obtained at the end of treatment. The total duration of treatment, from the start of active treatment to its completion, was also compared among the three groups." "The findings of this study may help clinicians and patients better understand the advantages and limitations of in-house clear aligner production compared to conventional fixed appliances, particularly regarding treatment efficiency and duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups: direct in-house clear aligners, indirect in-house clear aligners, or fixed orthodontic treatment.
| Arm | Type | Receives |
|---|---|---|
| Group A ( Direct - In-House) | Experimental | Device: Direct In-House Clear AlignersParticipants received clear aligners manufactured directly by the clinician using 3D printing with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea). |
| Group B ( Indirect - In-House) | Experimental | Device: Indirect In-House Clear AlignersParticipants received clear aligners manufactured indirectly by the clinician via 3D-printed models followed by thermoforming with CA Pro+ sheets (SCHEU-DENTAL GmbH, Iserlohn, Germany). |
| Group C (Fixed Orthodontic Treatment) | Active comparator | Device: Fixed Orthodontic AppliancesParticipants received conventional fixed orthodontic treatment with metal brackets (AO Mini Master Roth 018). |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Presence of permanent dentition (no primary teeth remaining)
- Non-extraction orthodontic treatment plan
- Age between 12 and 30 years
- Mild to moderate dental crowding (0-6 mm)
- Skeletal Class I classification (ANB: 2±2°)
Key exclusion criteria (5 listed)
- Presence of craniofacial anomalies
- Systemic disease or condition
- Previous fixed orthodontic treatment
- History of allergy to dental materials
- History of xerostomia
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 In-House Clear AlignersClear aligners fabricated directly by the clinician using a stereolithography (SLA) 3D printer (Asiga MAX UV) with a shape-memory resin (Tera Harz TC-85, Graphy Inc., Seoul, Korea). The shell of the aligner was designed digitally using Direct Aligner Designer software and printed directly, without the need for a physical model. Printed aligners were post-processed by centrifugation to remove excess resin, followed by UV light curing. | Device | Group A ( Direct - In-House) |
| Indirect In-House Clear AlignersClear aligners fabricated indirectly by the clinician via 3D-printed dental models (Asiga MAX UV printer) followed by thermoforming using CA Pro+ sheets (0.75 x 120 mm, SCHEU-DENTAL GmbH, Iserlohn, Germany) with a pressure-forming machine (MINISTAR S). The thermoformed aligners were trimmed from the printed model after shaping. | Device | Group B ( Indirect - In-House) |
| Fixed Orthodontic AppliancesConventional fixed orthodontic treatment using metal brackets (AO, Mini Master Roth 018, ) bonded to the upper and lower dental arches with stainless steel archwires. | Device | Group C (Fixed Orthodontic Treatment) |
Primary outcome
Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS)
Time frame: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months
Post-treatment dental models were evaluated using the ABO Objective Grading System, which scores eight criteria: tooth alignment, marginal ridge height, buccolingual inclination, overjet, occlusal contacts, occlusal relationships, interproximal contacts, and root angulation. Lower total scores indicate better treatment quality. Scores were classified as successful (<20), borderline (20-30), or unsuccessful (>30).
1 secondary outcome
Total Treatment Duration
Time frame: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ahmet Yağcı, Prof. Dr. principal investigator
Erciyes University, Faculty of Dentistry, Department of Orthodontics
Musa Göksu, DDS study director
Erciyes University, Faculty of Dentistry, Department of Orthodontics
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 In-House Clear Aligners, Indirect In-House Clear Aligners and Fixed Orthodontic Appliances in people with Malocclusion, Angle Class I, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 12 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: finished, as of the sponsor's last update on 7 Jul 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 Turkey (Türkiye). 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?
Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS) (time frame: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 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 7 Jul 2026.