NCT03141788

Evaluation of Clear Aligner Trays to Straighten Teeth

Completed NA Results posted Last updated 2 December 2024

What this trial tests

NA trial testing Clear Aligner in Malocclusion in 52 participants. Completed in 9 October 2019.

Timeline

30 January 2017

Primary endpoint
9 October 2019

9 October 2019

Quick facts

Lead sponsor	Solventum Orthodontics Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	30 January 2017
Primary completion	9 October 2019
Estimated completion	9 October 2019
Sites	9 locations across United States

Drugs / interventions tested

• Clear Aligner

Conditions studied

• Malocclusion — all drugs for Malocclusion →

Sponsor

Solventum Orthodontics Corporation

Who can join

14 and older, any sex, with Malocclusion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Successful Correction of Malocclusion Primary · 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.

Group	Value	95% CI
3M Clear Aligner	32
3M Clear Aligner	20

Treatment Time for Tooth Movement Secondary · 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

Group	Value	95% CI
3M Clear Aligner	443	14 – 853

Effective Use of Attachments Secondary · 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

Group	Value	95% CI
3M Clear Aligner	5.4	± 14.58

Orthodontist Satisfaction Secondary · 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

Group	Value	95% CI
3M Clear Aligner	5
3M Clear Aligner	33
3M Clear Aligner	7
3M Clear Aligner	2

Aligner Comfort Secondary · 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

Group	Value	95% CI
3M Clear Aligner	24
3M Clear Aligner	390
3M Clear Aligner	41
3M Clear Aligner	22

Appearance Satisfaction Secondary · 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

Group	Value	95% CI
3M Clear Aligner	470
3M Clear Aligner	9

Aligner Ease of Cleaning Secondary · 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

Group	Value	95% CI
3M Clear Aligner	436
3M Clear Aligner	43

Ease of Insertion Secondary · 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

Group	Value	95% CI
3M Clear Aligner	364
3M Clear Aligner	97
3M Clear Aligner	15
3M Clear Aligner	3

Mid Course Corrections/Refinements Needed Secondary · 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

Group	Value	95% CI
3M Clear Aligner	21
3M Clear Aligner	19
3M Clear Aligner	8
3M Clear Aligner	4

Ease of Aligner Removal Secondary · 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

Group	Value	95% CI
3M Clear Aligner	308
3M Clear Aligner	136
3M Clear Aligner	32
3M Clear Aligner	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 28 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

3M Clear Aligner

Serious: 0/52 (0%)

Deaths: 0/52

Other adverse events (2 terms — click to expand)

Reaction	System	3M Clear Aligner
Bleeding Gums	Gastrointestinal disorders	—
Filling Fell Off Tooth	Product Issues	—

Data from ClinicalTrials.gov NCT03141788 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.