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)

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

Study Overview

• Status: Terminated
• Conditions: Teeth Straightening; Aligner Therapy; Orthodontic Aligner
• Intervention / Treatment: Device: Nighttime Aligners; Device: Daytime Aligners

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redondo Beach, California, United States, 90277
      • Fulbright Dental
  • Florida
    • Miami Beach, Florida, United States, 33140
      • 3D Dental
  • Maryland
    • Towson, Maryland, United States, 21204
      • Elite Dental of Towson
  • Massachusetts
    • Plainville, Massachusetts, United States, 02762
      • Cedars Family Dental
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • R. Lobato & Associates
  • New Jersey
    • North Bergen, New Jersey, United States, 07047
      • Aesthetic Dental
  • New York
    • New York, New York, United States, 10001
      • Huerta Dentistry
  • Texas
    • Frisco, Texas, United States, 75035
      • Brush365
    • Humble, Texas, United States, 77396
      • Gustafson Dental
    • Hurst, Texas, United States, 76003
      • SKM Dentistry d/b/a brush365 Dental
  • Washington
    • Puyallup, Washington, United States, 98372
      • Northwest Dental Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 17655
      • Gregson Family Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).
7. 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.
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.

Exclusion Criteria:

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.
6. Subjects who have active carries, where there is no plan to correct them prior to the 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. clinically significant periodontal disease or gingivitis, interproximal decay, etc.).
8. The subject require interproximal reduction or attachments to obtain a corrected malocclusion.

9. 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
10. Known pregnancy, pregnancy tests will be performed as per local requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nighttime Aligners; Nighttime Aligners worn 10-12 hours per day or night	Device: Nighttime Aligners; Nighttime aligners worn 10-12 hours per day or night during 2-8 months
Active Comparator: Daytime Aligners; Daytime aligners worn 20-22 hours day and night	Device: Daytime Aligners; Daytime aligners worn 20-22 hours per day or night during 2-8 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction With the Treatment	Overall subject satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied).	At the final visit (2-8 months post day 0)
Dentist (Investigator) Satisfaction With the Treatment	Overall dentist (investigator) satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied).	At the final visit (2-8 months post day 0)
Subject Self-reported Pain/Discomfort	The subject self-reported values pertaining to pain/discomfort during treatment and comfort in wearing the aligners captured in a questionnaire with Visual Analogue Scale (VAS) with a Wong Baker face scale (score 0-10), where a higher score corresponds to a higher level of 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).

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Study Director: Jay Khorsandi, Dr, BYTE

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: C-OR-24-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No