Trial Outcomes & Findings for The Use of Clear Aligners With Movement Enhancement Techniques (NCT NCT02087163)

Results Overview

Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

Baseline and end of treatment, an average of 78 weeks

Results posted on

2020-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Movement Enhancement Technique Movement Enhancement Technique Clear Aligner Movement Enhancement Technique: Conventional Orthodontic treatment Clear Aligner: Orthodontic treatment with Clear Aligner
Overall Study STARTED	90
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Movement Enhancement Technique n=90 Participants Movement Enhancement Technique Clear Aligner Movement Enhancement Technique: Conventional Orthodontic treatment Clear Aligner: Orthodontic treatment with Clear Aligner
Age, Categorical <=18 years	0 Participants n=90 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=90 Participants
Age, Categorical >=65 years	0 Participants n=90 Participants
Sex: Female, Male Female	70 Participants n=90 Participants
Sex: Female, Male Male	20 Participants n=90 Participants
Region of Enrollment United States	90 participants n=90 Participants

PRIMARY outcome

Timeframe: Baseline and end of treatment, an average of 78 weeks

Population: all completed subjects

Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner.

Outcome measures

Outcome measures
Measure	Movement Enhancement Technique n=73 Participants Movement Enhancement Technique Clear Aligner Movement Enhancement Technique: Conventional Orthodontic treatment Clear Aligner: Orthodontic treatment with Clear Aligner
Tooth Movement Change	0.363 millimeters Interval -0.22 to 0.45

SECONDARY outcome

Timeframe: Baseline and end of treatment, an average of 78 weeks

Population: all completed subjects

Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner.

Outcome measures

Outcome measures
Measure	Movement Enhancement Technique n=73 Participants Movement Enhancement Technique Clear Aligner Movement Enhancement Technique: Conventional Orthodontic treatment Clear Aligner: Orthodontic treatment with Clear Aligner
Length of Treatment Change	342 days Interval -37.08 to 441.27

Adverse Events

Movement Enhancement Technique

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison Mossing

Align Technology

Phone: 4084701056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place