NCT07053189

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

Effects of Interproximal Reduction and Attachment Application on Effectiveness of Rotational Tooth Movement in Clear Aligner Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Lokman Hekim University · Other Government
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Clear Aligner treatment	Interproximal enamel reduction and attachment impact

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-01-01
• Completion: 2021-07-01
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study