TerminatedNot Applicable

A Study to Compare Nighttime Aligners to Daytime Aligners

Stopped: Sponsor's decision to terminate study.

United States7 participantsStarted 2024-09-04

Plain-language 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

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Subject willing to participate in the clinical study and able to understand the content of the clinical study.
✓. Subject must have permanent dentition (i.e. all second molars).
✓. Subject must be 12 years of age or older.
✓. 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).
✓. The subject requires correction of teeth without planned extrusive movements on either or both arches.
✓. The subject has no greater than 5 mm of crowding and/or spacing (based on estimation by Investigator).
✓. The subject does not require planned correction of molar tooth positions, posterior bite or molar classic relationship corrections. Subjects with Class II or Class III malocclusions requiring posterior bite / class correction are not eligible.
✓. Subjects without prior orthodontic treatment within the past 18 months.

Exclusion criteria

What they're measuring

Peer Assessment Rating (PAR) Index

Timeframe: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)

Trial details

NCT IDNCT06539676

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-17

Results submitted2025-05-23

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