7 Participants Needed

Nighttime vs Daytime Clear Aligners

Recruiting at 11 trial locations
UB
AL
Overseen ByAnnaKarin Lundgren
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Dentsply Sirona Implants and Consumables
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The available research does not provide any data on the effectiveness of Nighttime vs Daytime Clear Aligners. The studies focus on topics like school performance, sleep patterns, and circadian preferences, but do not mention clear aligners or their effectiveness as a treatment.12345

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?

The information provided does not include any relevant research articles about Daytime Aligners or Nighttime Aligners, so we cannot determine if they are a promising treatment based on this data.1112131415

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

JK

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

I haven't had braces or any orthodontic treatment in the last 18 months.
I am 12 years old or older.
I am willing and able to participate in the study.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orthodontic aligner therapy with either Daytime or Nighttime Aligners, randomly assigned

8-10 months
Approximately 5 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of satisfaction and adverse events

2-8 months

Treatment Details

Interventions

  • Daytime Aligners
  • Nighttime Aligners
Trial Overview The study compares two types of aligners: Nighttime Aligners worn for 10-12 hours a night versus standard Daytime Aligners worn for 20-22 hours a day. It will assess how well each aligner moves teeth compared to planned movements, any device-related side effects, and satisfaction levels.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Nighttime AlignersExperimental Treatment1 Intervention
Nighttime Aligners worn 10-12 hours per day or night
Group II: Daytime AlignersActive Control1 Intervention
Daytime aligners worn 20-22 hours day and night

Daytime Aligners is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Invisalign for:
  • Mild to severe tooth misalignment
  • Overcrowding
  • Gaps between teeth
  • Overbites
  • Underbites
🇺🇸
Approved in United States as Invisalign for:
  • Mild to severe tooth misalignment
  • Overcrowding
  • Gaps between teeth
  • Overbites
  • Underbites
🇨🇦
Approved in Canada as Invisalign for:
  • 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

Trials
68
Recruited
4,800+

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

Findings from Research

The 'Better Nights/Better Days' intervention significantly reduced sleep problems and improved psychosocial functioning in school-aged children, regardless of ADHD diagnosis, based on a randomized controlled trial with 61 participants.
Actigraphy data showed that while the intervention improved sleep onset, it did not affect sleep duration, indicating a targeted effect on how quickly children fall asleep.
Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial.Corkum, P., Lingley-Pottie, P., Davidson, F., et al.[2019]
In a study of 280 adolescents aged 14-16, evening-oriented individuals reported lower health-related quality of life (HRQoL) and more insomnia symptoms compared to morning-oriented peers, highlighting a negative correlation between eveningness and overall well-being.
Insomnia symptoms were found to mediate the relationship between chronotype and HRQoL, with sleep-related dysfunctional cognitions being a strong predictor for evening types, while self-efficacy was a key predictor for morning types, suggesting tailored interventions could improve HRQoL based on circadian preference.
Health-related quality of life in adolescent chronotypes--a model for the effects of sleep problems, sleep-related cognitions, and self-efficacy.Roeser, K., Brückner, D., Schwerdtle, B., et al.[2015]
A systematic review of 26 studies found that students who prefer mornings tend to achieve better academically, while those who prefer evenings tend to perform worse, with these effects mediated by factors like conscientiousness and motivation.
In a longitudinal study of 764 German high school students, morningness was shown to positively influence academic performance over time, indicating a reciprocal relationship where better grades can also lead to a stronger morning preference.
Circadian preference and academic achievement in school-aged students: a systematic review and a longitudinal investigation of reciprocal relations.Scherrer, V., Preckel, F.[2021]

References

Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. [2019]
Health-related quality of life in adolescent chronotypes--a model for the effects of sleep problems, sleep-related cognitions, and self-efficacy. [2015]
Circadian preference and academic achievement in school-aged students: a systematic review and a longitudinal investigation of reciprocal relations. [2021]
Interaction between personal sleep-wake rhythms and psychiatric hospital rest-activity schedule. [2006]
School start times matter, eveningness does not. [2019]
Adverse Events Related to Direct-To-Consumer Sequential Aligners-A Study of the MAUDE Database. [2023]
3D Printing of Clear Orthodontic Aligners: Where We Are and Where We Are Going. [2020]
Analysis of adverse events with use of orthodontic sequential aligners as reported in the manufacturer and user facility device experience database. [2017]
Periodontal health during orthodontic treatment with clear aligners and fixed appliances: A meta-analysis. [2022]
Treatment outcome with orthodontic aligners and fixed appliances: a systematic review with meta-analyses. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
The predictability of expansion with Invisalign: A retrospective cohort study. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. [2020]
14.United Statespubmed.ncbi.nlm.nih.gov
Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). [2020]
15.United Statespubmed.ncbi.nlm.nih.gov
Comparison of neointimal coverage between durable-polymer everolimus-eluting stents and bioresorbable-polymer everolimus-eluting stents 1 year after implantation using high-resolution coronary angioscopy. [2020]
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