Malocclusion; Displaced or Missing TeethCATNCT07053189
Evaluation of IPR and Attachments on Rotational Tooth Movement in Clear Aligner Therapy
A study testing Clear Aligner treatment in people with Malocclusion; Displaced or Missing Teeth, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
This study is testing whether clear aligners (Invisalign®) can help fix teeth that are rotated. The researchers want to learn if using two common methods-interproximal enamel reduction (IPR) and attachments-makes rotation correction more successful. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Malocclusion; Displaced or Missing Teeth
- What is being tested?
- Clear Aligner treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jul 2021
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with full permanent dentition (excluding wisdom teeth)
- Angle Class I malocclusion
- Mild to moderate crowding in the upper and lower arches
- Planned treatment with clear aligners for both jaws
- Rotated teeth within the correction limits recommended by Align Technology®
- Willing and able to wear aligners for 20-22 hours per day
- Able to attend follow-up visits every 2 aligners (~4 weeks)
- -
Who cannot join
- Previous orthodontic treatment
- Need for additional orthodontic appliances (e.g., elastics or rubber bands)
- Periodontal disease or other active oral health problems
- Presence of prosthetic dental work (e.g., crowns or bridges)
- Need for tooth extraction during aligner treatment
- Medical conditions that may interfere with orthodontic treatment compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Interproximal Reduction and Attachment Application on Effectiveness of Rotational Tooth Movement in Clear Aligner Therapy
This study is testing whether clear aligners (Invisalign®) can help fix teeth that are rotated. The researchers want to learn if using two common methods-interproximal enamel reduction (IPR) and attachments-makes rotation correction more successful.
Participants in the study will wear custom-made aligners for about 20 to 22 hours every day. They will switch to a new set of aligners every 2 weeks.
Read more
The study will look at tooth movement over time by using a digital planning tool called ClinCheck®, which helps plan and measure how much teeth have moved.
The researchers want to answer three main questions:
Do Invisalign® aligners work well for correcting rotated teeth?
Does IPR help improve rotation correction?
Do attachments help improve rotation correction?
The goal is to understand whether these tools work better together or separately to move teeth into better alignment.
Read the detailed description
This study is about clear aligners, which are plastic trays that gently move teeth. The researchers want to know how well aligners can fix teeth that are rotated (turned out of their normal position). They also want to test whether two common tools-interproximal enamel reduction (IPR) and attachments-help aligners work better when correcting rotated teeth.
IPR means gently shaving a small amount of enamel between teeth to make space for movement.
Attachments are small, tooth-colored bumps added to teeth to help the aligners grip better and apply more force.
The study includes 35 participants who are being treated with Invisalign® clear aligners. All of them have full adult teeth (except wisdom teeth), mild to moderate crowding, and a type of bite called Class I malocclusion.
Participants wear their aligners for 20 to 22 hours a day, changing to a new set every 2 weeks. The average treatment includes about 18 aligners.
Each participant had a digital scan of their teeth taken at the beginning using an iTero Element® scanner. This scan was used to design a personalized treatment plan using ClinCheck® software, which predicts how the teeth should move.
During treatment, researchers place:
Rectangular attachments on some front and back teeth to improve control
Optimized attachments on teeth that are rotated more than 0.5°, especially premolars and canines
- Conditions
- Malocclusion; Displaced or Missing Teeth
- Being tested
- Clear Aligner treatment
- Keywords
- rotation, interproximal enamel reduction, attachment, clear aligner therapy, effectiveness
- Medical subject headings
- Malocclusion, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Aligner treatmentDevice
Interproximal enamel reduction and attachment impact
| Study group | Role | What they receive |
|---|---|---|
| Rotational tooth movement in clear aligner therapy | Experimental | Not described Receives: Device: Clear Aligner treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tooth rotation (degrees) from baseline (T0) to refinement (T1), measured from Clincheck software
Comparison of tooth rotation correction with IPR and attachments
Measured: 36,9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion; Displaced or Missing 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aylin Alaçam, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053189
- Sponsor's protocol ID
- IRB No: 100/050/REK.001
- Acronym
- CAT
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Protect personal data
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interproximal Reduction and Attachment Application on Effectiveness of Rotational Tooth Movement in Clear Aligner Therapy
- ClinicalTrials.gov ID
- NCT07053189
- Acronym / sponsor ID
- CAT / IRB No: 100/050/REK.001
- Conditions
- Malocclusion; Displaced or Missing Teeth
- Keywords
- rotation, interproximal enamel reduction, attachment, clear aligner therapy, effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 8 Jul 2025 (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.
This study is testing whether clear aligners (Invisalign®) can help fix teeth that are rotated. The researchers want to learn if using two common methods-interproximal enamel reduction (IPR) and attachments-makes rotation correction more successful.
Participants in the study will wear custom-made aligners for about 20 to 22 hours every day. They will switch to a new set of aligners every 2 weeks.
The study will look at tooth movement over time by using a digital planning tool called ClinCheck®, which helps plan and measure how much teeth have moved.
The researchers want to answer three main questions:
Do Invisalign® aligners work well for correcting rotated teeth?
Does IPR help improve rotation correction?
Do attachments help improve rotation correction?
The goal is to understand whether these tools work better together or separately to move teeth into better alignment.
Detailed description
This study is about clear aligners, which are plastic trays that gently move teeth. The researchers want to know how well aligners can fix teeth that are rotated (turned out of their normal position). They also want to test whether two common tools-interproximal enamel reduction (IPR) and attachments-help aligners work better when correcting rotated teeth.
IPR means gently shaving a small amount of enamel between teeth to make space for movement.
Attachments are small, tooth-colored bumps added to teeth to help the aligners grip better and apply more force.
The study includes 35 participants who are being treated with Invisalign® clear aligners. All of them have full adult teeth (except wisdom teeth), mild to moderate crowding, and a type of bite called Class I malocclusion.
Participants wear their aligners for 20 to 22 hours a day, changing to a new set every 2 weeks. The average treatment includes about 18 aligners.
Each participant had a digital scan of their teeth taken at the beginning using an iTero Element® scanner. This scan was used to design a personalized treatment plan using ClinCheck® software, which predicts how the teeth should move.
During treatment, researchers place:
Rectangular attachments on some front and back teeth to improve control
Optimized attachments on teeth that are rotated more than 0.5°, especially premolars and canines
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotational tooth movement in clear aligner therapy | Experimental | Device: Clear Aligner treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults with full permanent dentition (excluding wisdom teeth)
- Angle Class I malocclusion
- Mild to moderate crowding in the upper and lower arches
- Planned treatment with clear aligners for both jaws
- Rotated teeth within the correction limits recommended by Align Technology®
Key exclusion criteria (6 listed)
- Previous orthodontic treatment
- Need for additional orthodontic appliances (e.g., elastics or rubber bands)
- Periodontal disease or other active oral health problems
- Presence of prosthetic dental work (e.g., crowns or bridges)
- Need for tooth extraction during aligner 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 |
|---|---|---|
| Clear Aligner treatmentInterproximal enamel reduction and attachment impact | Device | Rotational tooth movement in clear aligner therapy |
Primary outcome
Change in tooth rotation (degrees) from baseline (T0) to refinement (T1), measured from Clincheck software
Time frame: 36,9 weeks
Comparison of tooth rotation correction with IPR and attachments
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 8 Jul 2025.
- Individual participant dataSharing planned: No. Protect personal data
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligner treatment in people with Malocclusion; Displaced or Missing Teeth, run by Lokman Hekim 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 8 inclusion and 6 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 8 Jul 2025. 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?
Change in tooth rotation (degrees) from baseline (T0) to refinement (T1), measured from Clincheck software (time frame: 36,9 weeks). 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 8 Jul 2025.