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A Study to Compare Nighttime Aligners to Daytime Aligners | Clinical Trials | Clareo Health

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A Study to Compare Nighttime Aligners to Daytime Aligners

A Prospective, Two-armed, Multicenter Clinical Study to Evaluate Efficacy, Performance, and Safety of Nighttime Aligners (Worn 10-12 Hours Day or Night) Compared to Daytime Aligners (Worn 20-22 Hours Day/Night)

NCT06539676•Dentsply Sirona Implants and Consumables

View on ClinicalTrials.gov

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject willing to participate in the clinical study and able to understand the content of the clinical study.
•2. Subject must have permanent dentition (i.e. all second molars).
•3. Subject must be 12 years of age or older.
•4. Subject must be able to provide and sign consent for themselves, without requiring consent to be given by a legally authorized representative. Parental consent is also required for all participants who are not of the legal age to provide consent themselves (based on participant state of residence).
•5. The subject requires correction of teeth without planned extrusive movements on either or both arches.
•6. The subject has no greater than 5 mm of crowding and/or spacing (based on estimation by Investigator).

Exclusion Criteria

•8. Subjects without prior orthodontic treatment within the past 18 months.
•9. Subjects who are periodontally stable.
•10. Subjects without a known history of plastic allergies.
•11. Subjects who have not had or do not require tooth extractions in preparation for orthodontic treatment with aligners.
•12. Subjects with a treatment plan that does not include the use of elastics.
•1. Unlikely to be able to comply with clinical study procedures according to Investigator's judgement.
•2. Unable or unwilling to return for follow-up visits.
•3. Previous enrolment in the present clinical study.
•4. Involvement in the planning and conduct of the clinical study (applies to both Sponsor personnel and the clinical study site)
•5. Participation in another clinical study that may interfere with the present clinical study.
+11 more criteria

Locations (12)

Fulbright Dental

Redondo Beach, California, United States

3D Dental

Miami Beach, Florida, United States

Elite Dental of Towson

Towson, Maryland, United States

Cedars Family Dental

Plainville, Massachusetts, United States

R. Lobato & Associates

Las Vegas, Nevada, United States

Aesthetic Dental

North Bergen, New Jersey, United States

Huerta Dentistry

New York, New York, United States

Brush365

Frisco, Texas, United States

Gustafson Dental

Humble, Texas, United States

SKM Dentistry d/b/a brush365 Dental

Hurst, Texas, United States

Key Dates

Start Date

September 4, 2024

Primary Completion Date

January 17, 2025

Completion Date

January 17, 2025

Last Updated

July 16, 2025

Enrollment

ACTUAL participants

Conditions

Teeth StraighteningAligner TherapyOrthodontic Aligner

Interventions

Nighttime Aligners

DEVICE

Daytime Aligners

DEVICE

Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy

NCT06380946

Effect of Platelet Rich FibrinDuring Clear Aligner Therapy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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