Evaluation of Clear Aligner Trays to Straighten Teeth
Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study
1 other identifier
interventional
52
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2017
CompletedFirst Submitted
Initial submission to the registry
April 27, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2019
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedDecember 2, 2024
November 1, 2024
2.7 years
April 27, 2017
September 14, 2020
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful Correction of Malocclusion
Achievement of target setup per treatment plan as determined by Orthodontist.
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 (11)
Individual Tooth Movement
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.
Treatment Time for Tooth Movement
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.
Effective Use of Attachments
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.
Orthodontist Satisfaction
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.
Software Satisfaction
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.
- +6 more secondary outcomes
Study Arms (1)
3M Clear Aligner
OTHERClear Aligner for Orthodontic Treatment
Interventions
Clear Aligner used to straighten teeth to desired outcome
Eligibility Criteria
You may qualify if:
- Subject is at least 14 years of age.
- Subject is willing and able to give informed consent.
- Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
- Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
- Subject has good oral hygiene defined by the orthodontist.
- Subject has only permanent dentition.
You may not qualify if:
- Subject has skeletal discrepancies requiring surgery
- Subject is undergoing active dental work
- Subject has severe open bite \> 2 mm
- Subject has severe overjet \> 4 mm
- Subject has deep bite \> 3 mm
- Subject has over crowding per arch \> 4 mm
- Subject has dental prostheses/implants that will interfere with projected teeth movement
- Subject is taking systemic steroid medication
- Subject is taking Biphosphonates or any other medication for treatment of osteoporosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solventum Orthodontics Corporationlead
- 3Mcollaborator
Study Sites (9)
Benson Orthodontics
Denver, Colorado, 80209-3244, United States
Depew Orthodontics
Kennesaw, Georgia, 30144, United States
Orthodontics Associates
Catonsville, Maryland, 21228, United States
Henseler Orthodontics
Woodbury, Minnesota, 55125, United States
Horton Orthodontics
Woodbury, Minnesota, 55125, United States
Mellion Orthodontics
Fairlawn, Ohio, 44333, United States
Wolf/Chhibber Orthodontics
Norwalk, Ohio, 44857, United States
Simply Smiles Orthodontics
McKinney, Texas, 75070, United States
Riolo Orthodontics
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elaine Egging
- Organization
- 3M
Study Officials
- STUDY DIRECTOR
Gail E Maxey, BA, CCRA
3M Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2017
First Posted
May 5, 2017
Study Start
January 30, 2017
Primary Completion
October 9, 2019
Study Completion
October 9, 2019
Last Updated
December 2, 2024
Results First Posted
November 4, 2020
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share