Maxillary Lateral Incisor Malocclusion
Conditions
Brief summary
The purpose of this research is to test which of four clear aligner attachment types is more efficient in extruding (erupting) maxillary lateral incisors vertically into correct position during orthodontic treatment.
Detailed description
Attachments are small tooth-colored shapes that are bonded (attached) to teeth before or during treatment with clear aligners. They are like handles, giving aligners something to gently push teeth into correct positions. There are 4 different shapes of attachments that are commonly used to extrude lateral incisors (incisally-beveled, gingivally-beveled, optimized and horizontal). All 4 of these attachments are successful in extruding lateral incisors but there is not enough research evidence to know for sure which attachment would be ideal for a specific circumstance.
Interventions
DEVICEIncisally-beveled attachment
Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
DEVICEGingivally-beveled attachment
Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
DEVICEOptimized attachment
Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
DEVICEHorizontal attachment
Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients 16 years or older to be treated with either Comprehensive Invisalign or Invisalign Teen, 2. Maxillary lateral incisor requiring 0.3 mm or more extrusion (as determined by ClinCheck), 3. Maxillary arch with less than 6 mm of crowding or spacing, 4. All teeth present and fully erupted (excluding third molars).
Exclusion criteria
1. Presence of anterior crossbite 2. Any missing teeth in the maxillary arch 3. Treatment plan includes surgery or extraction of any maxillary teeth, 4. Maxillary lateral incisors with pathology or large restorations (crowns) 5. Maxillary lateral incisors have a less than 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Vertical Tooth Movement | 6 months | Percent achieved of the vertical (inciso-gingival) tooth movement will be assessed by comparing the initial ClinCheck software estimate tooth movement required to the amount of tooth movement observed |
Countries
United States
Participant flow
Recruitment details
Recruitment began August, 2021 and final data collection was completed in June, 2022. Patients were recruited from 3 orthodontic practices. Units enrolled are counted as numbers of teeth. Potentially, 2 maxillary lateral incisors from each patient could have been enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Incisally-beveled Use of incisally-beveled attachment to extrude lateral incisor
Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | 15 |
| Gingivally-beveled Use of gingivally-beveled attachment to extrude lateral incisor
Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | 14 |
| Optimized Use of optimized attachment to extrude lateral incisor
Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | 22 |
| Horizontal Use of horizontal (unbeveled) attachment to extrude lateral incisor
Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | 19 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Non-compliance | 1 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Gingivally-beveled | Optimized | Horizontal | Incisally-beveled | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 9 Participants | 8 Participants | 2 Participants | 20 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 11 Participants | 12 Participants | 48 Participants |
| Age, Continuous | 31.2 years STANDARD_DEVIATION 15.6 | 32.1 years STANDARD_DEVIATION 14.26 | 30.4 years STANDARD_DEVIATION 15.16 | 31.4 years STANDARD_DEVIATION 15.3 | 31.3 years STANDARD_DEVIATION 15.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 15 Participants | 12 Participants | 9 Participants | 45 Participants |
| Region of Enrollment United States | 16 participants | 22 participants | 20 participants | 15 participants | 73 participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 13 Participants | 12 Participants | 49 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 6 Participants | 3 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 15 | 0 / 14 | 0 / 22 |
| other Total, other adverse events | 0 / 19 | 0 / 15 | 0 / 14 | 0 / 22 |
| serious Total, serious adverse events | 0 / 19 | 0 / 15 | 0 / 14 | 0 / 22 |
Outcome results
Primary
Percent of Vertical Tooth Movement
Percent achieved of the vertical (inciso-gingival) tooth movement will be assessed by comparing the initial ClinCheck software estimate tooth movement required to the amount of tooth movement observed
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Horizontal | Percent of Vertical Tooth Movement | 79 percentage of predicted |
| Incisally-beveled | Percent of Vertical Tooth Movement | 78 percentage of predicted |
| Gingivally-beveled | Percent of Vertical Tooth Movement | 78 percentage of predicted |
| Optimized | Percent of Vertical Tooth Movement | 62 percentage of predicted |