A Study to Compare Nighttime Aligners to Daytime Aligners

NCT06539676 | Terminated Results FDA Device

• 1 other identifier: C-OR-24-017
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (1)

• Peer Assessment Rating (PAR) Index

  Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device

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

Secondary Outcomes (3)

• Subject Satisfaction With the Treatment

  At the final visit (2-8 months post day 0)

• Dentist (Investigator) Satisfaction With the Treatment

  At the final visit (2-8 months post day 0)

• Subject Self-reported Pain/Discomfort

  At each follow-up visit (Follow-up visits every 4-6 weeks post Day 0 during a 2-8 months period) and at the final visit (Day 0 + 2-8 months).

Study Arms (2)

Nighttime Aligners

EXPERIMENTAL

Nighttime Aligners worn 10-12 hours per day or night

Device: Nighttime Aligners

Daytime Aligners

ACTIVE COMPARATOR

Daytime aligners worn 20-22 hours day and night

Device: Daytime Aligners

Interventions

Nighttime Aligners DEVICE

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

Nighttime Aligners

Daytime Aligners DEVICE

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

Daytime Aligners

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects who are periodontally stable.
• Subjects without a known history of plastic allergies.
• Subjects who have not had or do not require tooth extractions in preparation for orthodontic treatment with aligners.
• Subjects with a treatment plan that does not include the use of elastics.

You may not qualify if:

• Unlikely to be able to comply with clinical study procedures according to Investigator's judgement.
• Unable or unwilling to return for follow-up visits.
• Previous enrolment in the present clinical study.
• Involvement in the planning and conduct of the clinical study (applies to both Sponsor personnel and the clinical study site)
• Participation in another clinical study that may interfere with the present clinical study.
• Subjects who have active carries, where there is no plan to correct them prior to the start of aligner therapy.
• Other dental or clinical pathologies, which in the judgment of the Investigator, deem the candidates inappropriate for participation in the study (e.g. clinically significant periodontal disease or gingivitis, interproximal decay, etc.).
• The subject require interproximal reduction or attachments to obtain a corrected malocclusion.
• In addition to the criteria listed above, this product is contraindicated for use in adult 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

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (12)

Fulbright Dental

Redondo Beach, California, 90277, United States

Location

3D Dental

Miami Beach, Florida, 33140, United States

Location

Elite Dental of Towson

Towson, Maryland, 21204, United States

Location

Cedars Family Dental

Plainville, Massachusetts, 02762, United States

Location

R. Lobato & Associates

Las Vegas, Nevada, 89117, United States

Location

Aesthetic Dental

North Bergen, New Jersey, 07047, United States

Location

Huerta Dentistry

New York, New York, 10001, United States

Location

Brush365

Frisco, Texas, 75035, United States

Location

Gustafson Dental

Humble, Texas, 77396, United States

Location

SKM Dentistry d/b/a brush365 Dental

Hurst, Texas, 76003, United States

Location

Northwest Dental Medicine

Puyallup, Washington, 98372, United States

Location

Gregson Family Dentistry

Milwaukee, Wisconsin, 17655, United States

Location

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Dentsply IH AB d.b.a Dentsply Sirona Implants

freja.freedman@dentsplysirona.com

+4631 3763191

Study Officials

• Jay Khorsandi, Dr

  BYTE

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: August 6, 2024
• Study Start: September 4, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)