A Study to Compare Nighttime Aligners to Daytime Aligners

Last updated: February 10, 2025
Sponsor: Dentsply Sirona Implants and Consumables
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Daytime Aligners

Nighttime Aligners

Clinical Study ID

NCT06539676
C-OR-24-017
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subject willing to participate in the clinical study and able to understand thecontent 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 requiringconsent to be given by a legally authorized representative. Parental consent is alsorequired for all participants who are not of the legal age to provide consentthemselves (based on participant state of residence).

  5. The subject requires correction of teeth without planned extrusive movements oneither or both arches.

  6. The subject has no greater than 5 mm of crowding and/or spacing (based on estimationby Investigator).

  7. The subject does not require planned correction of molar tooth positions, posteriorbite or molar classic relationship corrections. Subjects with Class II or Class IIImalocclusions requiring posterior bite / class correction are not eligible.

  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 fororthodontic treatment with aligners.

  12. Subjects with a treatment plan that does not include the use of elastics.

Exclusion

Exclusion Criteria:

  1. Unlikely to be able to comply with clinical study procedures according toInvestigator'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 bothSponsor personnel and the clinical study site)

  5. Participation in another clinical study that may interfere with the present clinicalstudy.

  6. Subjects who have active carries, where there is no plan to correct them prior tothe start of aligner therapy.

  7. Other dental or clinical pathologies, which in the judgment of the Investigator,deem the candidates inappropriate for participation in the study (e.g. clinicallysignificant periodontal disease or gingivitis, interproximal decay, etc.).

  8. The subject require interproximal reduction or attachments to obtain a correctedmalocclusion.

  9. In addition to the criteria listed above, this product is contraindicated for use inadult and adolescent subjects presenting with the following dental conditions:

  • Active periodontal disease

  • Severe open bite or severe overjet

  • Tooth malocclusion requiring surgical correction

  • Subject with mixed dentition

  • Subject with a skeletally narrow jaw

  • Dental prosthetics/implants or significant number of missing teeth

  1. Known pregnancy, pregnancy tests will be performed as per local requirements.

Study Design

Total Participants: 7
Treatment Group(s): 2
Primary Treatment: Daytime Aligners
Phase:
Study Start date:
September 04, 2024
Estimated Completion Date:
January 17, 2025

Connect with a study center

  • Fulbright Dental

    Redondo Beach, California 90277
    United States

    Site Not Available

  • 3D Dental

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Elite Dental of Towson

    Towson, Maryland 21204
    United States

    Site Not Available

  • Cedars Family Dental

    Plainville, Massachusetts 02762
    United States

    Site Not Available

  • R. Lobato & Associates

    Las Vegas, Nevada 89117
    United States

    Site Not Available

  • Aesthetic Dental

    North Bergen, New Jersey 07047
    United States

    Site Not Available

  • Huerta Dentistry

    New York, New York 10001
    United States

    Site Not Available

  • Brush365

    Frisco, Texas 75035
    United States

    Site Not Available

  • Gustafson Dental

    Humble, Texas 77396
    United States

    Site Not Available

  • SKM Dentistry d/b/a brush365 Dental

    Hurst, Texas 76003
    United States

    Site Not Available

  • Northwest Dental Medicine

    Puyallup, Washington 98372
    United States

    Site Not Available

  • Gregson Family Dentistry

    Milwaukee, Wisconsin 17655
    United States

    Site Not Available

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