NCT06539676
Terminated
Not Applicable
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)
Dentsply Sirona Implants and Consumables12 sites in 1 country7 target enrollmentStarted: September 4, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Dentsply Sirona Implants and Consumables
- Enrollment
- 7
- Locations
- 12
- Primary Endpoint
- Peer Assessment Rating (PAR) Index
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Peer Assessment Rating (PAR) Index
Time Frame: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device
Secondary Outcomes
- 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).)
Investigators
Study Sites (12)
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