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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:
Participants will:
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Volunteers
Inclusion criteria
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:
Known pregnancy, pregnancy tests will be performed as per local requirements.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
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Central trial contact
Ulrika Bonander; AnnaKarin Lundgren
Data sourced from clinicaltrials.gov
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