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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Nighttime aligners worn 10-12 hours per day or night during 2-8 months
Daytime aligners worn 20-22 hours per day or night during 2-8 months
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
...and 2 more locations
Peer Assessment Rating (PAR) Index
Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device
Time frame: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
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