Clinical trial NCT06539676: A Study to Compare Nighttime Aligners to Daytime Aligners
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Teeth Straightening
Aligner Therapy
Orthodontic Aligner
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Peer Assessment Rating (PAR) index
timeFrame: From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
Secondary outcomes:
measure: Subject satisfaction with the treatment
timeFrame: At the final visit (2-8 months post day 0)
measure: Dentist (Investigator) satisfaction with the treatment
timeFrame: At the final visit (2-8 months post day 0)
measure: Occurrence of Adverse Events (AEs)
timeFrame: Continuously collected and reported AEs at each visit from day 0 up to 8 months post treatment start (Final visit)
measure: Subject self-reported pain/discomfort
timeFrame: At each follow-up visit and at the final visit (1-8 months post day 0)
Other outcomes:
Locations:
city: Redondo Beach
country: United States
facility: Fulbright Dental
state: California
city: Miami Beach
country: United States
facility: 3D Dental
state: Florida
city: Towson
country: United States
facility: Elite Dental of Towson
state: Maryland
city: Plainville
country: United States
facility: Cedars Family Dental
state: Massachusetts
city: Las Vegas
country: United States
facility: R. Lobato & Associates
state: Nevada
city: North Bergen
country: United States
facility: Aesthetic Dental
state: New Jersey
city: New York
country: United States
facility: Huerta Dentistry
state: New York
city: Frisco
country: United States
facility: Brush365
state: Texas
city: Humble
country: United States
facility: Gustafson Dental
state: Texas
city: Hurst
country: United States
facility: SKM Dentistry d/b/a brush365 Dental
state: Texas
city: Puyallup
country: United States
facility: Northwest Dental Medicine
state: Washington
city: Milwaukee
country: United States
facility: Gregson Family Dentistry
state: Wisconsin
Study officials:
affiliation: BYTE
name: Jay Khorsandi, Dr
role: STUDY_DIRECTOR
References: