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A Study to Compare Nighttime Aligners to Daytime Aligners

NCT06539676 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-07-16

Study results available
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Summary

The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per day), in adults and children from 12 years of age and older.

It will investigate the efficacy and performance of the treatments, as well as the safety of the investigational device and comparator.

The main objectives are:

* Comparison between the two groups concerning actual vs planned tooth movements (measured by changes in tooth position)
* Comparison between the two groups concerning the incidence of device or dental related AEs.
* Overall dentist and participant satisfaction with the treatment.

Participants will:

* Be given orthodontic aligner therapy with the Daytime (20-22h/day) or Nighttime (10-12h/day) Aligners (randomly assigned)
* Attend approximately 5 study during approximately 8-10 months

Conditions

  • Teeth Straightening
  • Aligner Therapy
  • Orthodontic Aligner

Interventions

DEVICE

Nighttime Aligners

Nighttime aligners worn 10-12 hours per day or night during 2-8 months

DEVICE

Daytime Aligners

Daytime aligners worn 20-22 hours per day or night during 2-8 months

Sponsors & Collaborators

  • Dentsply Sirona Implants and Consumables

    lead INDUSTRY

Principal Investigators

  • Jay Khorsandi, Dr · BYTE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2025-01-17
Completion
2025-01-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06539676 on ClinicalTrials.gov