Status:
TERMINATED
A Study to Compare Nighttime Aligners to Daytime Aligners
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Teeth Straightening
Aligner Therapy
Eligibility:
All Genders
12+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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.
- Subjects who have not had or do not require tooth extractions in preparation for orthodontic treatment with aligners.
- Subjects with a treatment plan that does not include the use of elastics.
Exclusion
- 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
- 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
- Known pregnancy, pregnancy tests will be performed as per local requirements.
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06539676
Start Date
September 4 2024
End Date
January 17 2025
Last Update
July 16 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Fulbright Dental
Redondo Beach, California, United States, 90277
2
3D Dental
Miami Beach, Florida, United States, 33140
3
Elite Dental of Towson
Towson, Maryland, United States, 21204
4
Cedars Family Dental
Plainville, Massachusetts, United States, 02762