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

NCT07053189 | Completed FDA Device

• 1 other identifier: IRB No: 100/050/REK.001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malocclusion; Displaced or Missing Teeth

Keywords

rotation; interproximal enamel reduction; attachment; clear aligner therapy; effectiveness

Outcome Measures

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

  36,9 weeks

Study Arms (1)

Rotational tooth movement in clear aligner therapy

EXPERIMENTAL

Device: Clear Aligner treatment

Interventions

Clear Aligner treatment DEVICE

Interproximal enamel reduction and attachment impact

Rotational tooth movement in clear aligner therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

A special dental clinic

Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion; Anodontia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asis.Prof.,Lokman Hekim University, Faculty of Dentistry, Department of Orthodontics

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: July 8, 2025
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)