Phase
Condition
N/ATreatment
Daytime Aligners
Nighttime Aligners
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject willing to participate in the clinical study and able to understand thecontent 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 requiringconsent to be given by a legally authorized representative. Parental consent is alsorequired for all participants who are not of the legal age to provide consentthemselves (based on participant state of residence).
The subject requires correction of teeth without planned extrusive movements oneither or both arches.
The subject has no greater than 5 mm of crowding and/or spacing (based on estimationby Investigator).
The subject does not require planned correction of molar tooth positions, posteriorbite or molar classic relationship corrections. Subjects with Class II or Class IIImalocclusions 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 fororthodontic treatment with aligners.
Subjects with a treatment plan that does not include the use of elastics.
Exclusion
Exclusion Criteria:
Unlikely to be able to comply with clinical study procedures according toInvestigator'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 bothSponsor personnel and the clinical study site)
Participation in another clinical study that may interfere with the present clinicalstudy.
Subjects who have active carries, where there is no plan to correct them prior tothe 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. clinicallysignificant periodontal disease or gingivitis, interproximal decay, etc.).
The subject require interproximal reduction or attachments to obtain a correctedmalocclusion.
In addition to the criteria listed above, this product is contraindicated for use inadult 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.
Study Design
Connect with a study center
Fulbright Dental
Redondo Beach, California 90277
United StatesSite Not Available
3D Dental
Miami Beach, Florida 33140
United StatesSite Not Available
Elite Dental of Towson
Towson, Maryland 21204
United StatesSite Not Available
Cedars Family Dental
Plainville, Massachusetts 02762
United StatesSite Not Available
R. Lobato & Associates
Las Vegas, Nevada 89117
United StatesSite Not Available
Aesthetic Dental
North Bergen, New Jersey 07047
United StatesSite Not Available
Huerta Dentistry
New York, New York 10001
United StatesSite Not Available
Brush365
Frisco, Texas 75035
United StatesSite Not Available
Gustafson Dental
Humble, Texas 77396
United StatesSite Not Available
SKM Dentistry d/b/a brush365 Dental
Hurst, Texas 76003
United StatesSite Not Available
Northwest Dental Medicine
Puyallup, Washington 98372
United StatesSite Not Available
Gregson Family Dentistry
Milwaukee, Wisconsin 17655
United StatesSite Not Available
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