This Study Will Examine Shortened Treatment Wear Time for Patients With Mixed Dentition Using AirFlex Aligner, Sequential Dental Aligners.

NCT ID: NCT07220317

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief Summary

This study will examine shortened treatment wear time for patients with mixed dentition using sequential dental aligners. Using the existing AirFlex aligner design that patients with permanent dentition use, it may be possible to reduce the wear time and still provide dental realignment in an adequate treatment period for patients with mixed dentition. The Airflex aligner will be tested for a 9-12-hour patient wear time.

Detailed Description

The primary intervention is the change in active wear time. In current practice, sequential aligners are prescribed to be worn approximately 20 to 22 hours per day. In this study, the prescribed wear time will be reduced to 9 - 12 hours per day.

This study is intended to demonstrate effectiveness of AirFlex aligners, which have a reduced wear time compared to traditional aligners, in mixed dentition subjects. The study will be conducted using AirFlex aligners, which are currently cleared for treatment of patients with permanent dentition.

Conditions

Mixed Dentition Using Sequential Dental Aligners

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Short wear

Short wear

Group Type: EXPERIMENTAL

Sequential Aligners

Intervention Type: DEVICE

Treatment with sequential aligners in a shortened wear time with mixed dentition.

Interventions

Sequential Aligners

Treatment with sequential aligners in a shortened wear time with mixed dentition.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 7 to 21 years old
• Mixed dentition, as defined by the presence of at least one primary tooth present at the start of orthodontic treatment
• No untreated cavities
• Good Periodontal composition as determined by dental exam

Exclusion Criteria

• Skeletal discrepancies requiring surgery
• Is currently undergoing dental/orthodontic work
• Has dental prosthesis/implants that will interfere with projected tooth movement
• Ongoing use of medication affecting tooth movement or bone formation (NSAIDS, Steroids, Bisphosphonates, Levothyroxine, Teriparatides, etc.)
• Is currently pregnant or plans to become pregnant during treatment
• Current smoker or tobacco use within 2 years
• Presence of systemic diseases that could interfere with treatment
• Moderate or significant periodontal disease
• Any other physical exam finding that precludes participation

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrthoFX

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PRT-370

Identifier Type: -

Identifier Source: org_study_id