Clinical trial NCT03141788: Evaluation of Clear Aligner Trays to Straighten Teeth
Official title: Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Aligners
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2017-05-05
Enrollment: 52
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.

Detailed description: This is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3M Clear Aligners, with the use of attachments to correct teeth malocclusions.

The subject population for this study will be male and female subjects ≥ 14 years of age. Subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. Up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site).

The subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. Subjects will wear the Clear Aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. During each 6-week period between follow up visits, subjects will wear each set of Clear Aligners for 2 weeks, in the order indicated per the Orthodontists treatment plan.

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 14 years of age.
2. Subject is willing and able to give informed consent.
3. Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
4. Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
5. Subject has good oral hygiene defined by the orthodontist.
6. Subject has only permanent dentition.

Exclusion Criteria:

1. Subject has skeletal discrepancies requiring surgery
2. Subject is undergoing active dental work
3. Subject has severe open bite \> 2 mm
4. Subject has severe overjet \> 4 mm
5. Subject has deep bite \> 3 mm
6. Subject has over crowding per arch \> 4 mm
7. Subject has dental prostheses/implants that will interfere with projected teeth movement
8. Subject is taking systemic steroid medication
9. Subject is taking Biphosphonates or any other medication for treatment of osteoporosis

Primary outcomes:
measure: Successful Correction of Malocclusion
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Secondary outcomes:
measure: Individual Tooth Movement
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Treatment Time for Tooth Movement
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Effective Use of Attachments
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Orthodontist Satisfaction
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Software Satisfaction
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Aligner Comfort
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Appearance Satisfaction
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Aligner Ease of Cleaning
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Ease of Insertion
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Mid Course Corrections/Refinements Needed
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
measure: Ease of Aligner Removal
timeFrame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Benson Orthodontics
state: Colorado
city: Kennesaw
country: United States
facility: Depew Orthodontics
state: Georgia
city: Catonsville
country: United States
facility: Orthodontics Associates
state: Maryland
city: Woodbury
country: United States
facility: Henseler Orthodontics
state: Minnesota
city: Woodbury
country: United States
facility: Horton Orthodontics
state: Minnesota
city: Fairlawn
country: United States
facility: Mellion Orthodontics
state: Ohio
city: Norwalk
country: United States
facility: Wolf/Chhibber Orthodontics
state: Ohio
city: McKinney
country: United States
facility: Simply Smiles Orthodontics
state: Texas
city: Seattle
country: United States
facility: Riolo Orthodontics
state: Washington
Study officials:
affiliation: 3M Company
name: Gail E Maxey, BA, CCRA
role: STUDY_DIRECTOR
References: