Nighttime vs Daytime Clear Aligners
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on orthodontic aligners, it's unlikely that most medications would interfere. It's best to discuss your specific medications with the study team.
What data supports the idea that Nighttime vs Daytime Clear Aligners is an effective treatment?
What safety data exists for clear aligners?
Safety data for clear aligners, including direct-to-consumer (DTC) options, is available from the FDA's MAUDE database. Reports indicate adverse events such as bite problems, orofacial pain, and periodontal issues, especially when used without dental supervision. A study found 104 reports related to DTC aligners, with common issues being bite problems (41.3%), pain (29.8%), and periodontal sequelae (26.6%).678910
Is the treatment of Daytime Aligners and Nighttime Aligners a promising treatment?
What is the purpose of this trial?
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
Research Team
Jay Khorsandi, Dr
Principal Investigator
BYTE
Eligibility Criteria
This trial is for adults and children aged 12 or older with permanent teeth, needing mild dental corrections without prior orthodontic treatment in the last 18 months. Participants should not have severe crowding/spacing (>5mm), need molar position corrections, or have plastic allergies. They must understand the study and consent to participate.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive orthodontic aligner therapy with either Daytime or Nighttime Aligners, randomly assigned
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of satisfaction and adverse events
Treatment Details
Interventions
- Daytime Aligners
- Nighttime Aligners
Daytime Aligners is already approved in European Union, United States, Canada for the following indications:
- Mild to severe tooth misalignment
- Overcrowding
- Gaps between teeth
- Overbites
- Underbites
- Mild to severe tooth misalignment
- Overcrowding
- Gaps between teeth
- Overbites
- Underbites
- Mild to severe tooth misalignment
- Overcrowding
- Gaps between teeth
- Overbites
- Underbites
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dentsply Sirona Implants and Consumables
Lead Sponsor
Simon Campion
Dentsply Sirona Implants and Consumables
Chief Executive Officer since 2022
PhD in Chemistry from Texas A&M University
Dr. Patrizia Cavazzoni
Dentsply Sirona Implants and Consumables
Chief Medical Officer
MD from Harvard Medical School