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Completed

NCT Number: NCT03141788

Evaluation of Clear Aligner Trays to Straighten Teeth

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benson Orthodontics, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Clear aligner

Device

Clear Aligner used to straighten teeth to desired outcome

Other names: 3M Clear Aligner

Primary outcomes

  1. Successful Correction of Malocclusion

    Time frame: 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.

    Achievement of target setup per treatment plan as determined by Orthodontist.

Secondary outcomes

  1. Individual Tooth Movement

    Time frame: 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.

    Achievement of individual tooth movement measured per treatment plan and digital scan

  2. Treatment Time for Tooth Movement

    Time frame: 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.

    Achievement of individual tooth movement measured per treatment plan

  3. Effective Use of Attachments

    Time frame: 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 attachment by tracking attachment bond failures by visual assessment

  4. Orthodontist Satisfaction

    Time frame: 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 with treatment outcome

  5. Software Satisfaction

    Time frame: 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 with treatment management software -Ease of use in ordering products

  6. Aligner Comfort

    Time frame: 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.

    Aligner comfortable to wear

  7. Appearance Satisfaction

    Time frame: 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.

    Subject satisfaction with appearance during treatment

  8. Aligner Ease of Cleaning

    Time frame: 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.

    Subject satisfaction with ease of cleaning during treatment

  9. Ease of Insertion

    Time frame: 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.

    Subject satisfaction with treatment; specifically aligners easy to insert

  10. Mid Course Corrections/Refinements Needed

    Time frame: 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.

    Number of mid course refinements or corrections

  11. Ease of Aligner Removal

    Time frame: 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.

    Subject satisfaction with treatment; specifically with aligner removal

Sponsors and collaborators

Lead sponsor

Solventum Orthodontics Corporation

Industry

Collaborators

  • 3M

Registry information

Official study title

Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 5, 2017
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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