CClinicalTrials.gg
CompletedNCT07053189CATUpdated Jul 8, 2025

Evaluation of IPR and Attachments on Rotational Tooth Movement in Clear Aligner Therapy

An interventional study of Clear Aligner treatment in Malocclusion; Displaced or Missing Teeth, sponsored by Lokman Hekim University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Lokman Hekim University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2021, 5 years 9 months ago, and no results have been posted to the registry.
  • Registered 6 years 4 months after the study started (first participant enrolled Jan 2019, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

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.

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

02

Conditions studied

  • Malocclusion; Displaced or Missing Teeth

Keywords

  • rotation
  • interproximal enamel reduction
  • attachment
  • clear aligner therapy
  • effectiveness
03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 35 is close to the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Lokman Hekim University is the lead sponsor of 41 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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)

-

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Rotational tooth movement in clear aligner therapy

    Device: Clear Aligner treatment

Interventions

  • DeviceClear Aligner treatment

    Interproximal enamel reduction and attachment impact

06

What researchers measure

Primary outcomes

  1. Change in tooth rotation (degrees) from baseline (T0) to refinement (T1), measured from Clincheck software

    Comparison of tooth rotation correction with IPR and attachments

    Time frame: 36,9 weeks

07

Study locations

1 site
  • A special dental clinic
    Ankara, 06510, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Protect personal data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07053189
Lead sponsor
Lokman Hekim University
Responsible party
Aylin Alaçam (Asis.Prof.,Lokman Hekim University, Faculty of Dentistry, Department of Orthodontics, Lokman Hekim University) — Principal investigator
First posted
Jul 8, 2025
Start date
Jan 1, 2019
Primary completion
Jan 1, 2021
Completion
Jul 1, 2021
Last update
Jul 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion