Maxillary Lateral Incisor MalocclusionNCT04968353
Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors
A study testing Incisally-beveled attachment, Gingivally-beveled attachment and Optimized attachment in people with Maxillary Lateral Incisor Malocclusion, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maxillary Lateral Incisor Malocclusion
- What is being tested?
- Incisally-beveled attachment, Gingivally-beveled attachment and Optimized attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients 16 years or older to be treated with either Comprehensive Invisalign or Invisalign Teen,
- Maxillary lateral incisor requiring 0.3 mm or more extrusion (as determined by ClinCheck),
- Maxillary arch with less than 6 mm of crowding or spacing,
- All teeth present and fully erupted (excluding third molars).
Who cannot join
- Presence of anterior crossbite
- Any missing teeth in the maxillary arch
- Treatment plan includes surgery or extraction of any maxillary teeth,
- Maxillary lateral incisors with pathology or large restorations (crowns)
- Maxillary lateral incisors have a less than 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors: a Randomized Prospective Clinical Trial
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.
Read the 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.
- Conditions
- Maxillary Lateral Incisor Malocclusion
- Being tested
- Incisally-beveled attachment, Gingivally-beveled attachment, Optimized attachment, Horizontal attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisally-beveled attachmentDevice
Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Gingivally-beveled attachmentDevice
Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Optimized attachmentDevice
Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
Horizontal attachmentDevice
Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
| Study group | Role | What they receive |
|---|---|---|
| Incisally-beveled | Active comparator | Use of incisally-beveled attachment to extrude lateral incisor Receives: Device: Incisally-beveled attachment |
| Gingivally-beveled | Active comparator | Use of gingivally-beveled attachment to extrude lateral incisor Receives: Device: Gingivally-beveled attachment |
| Optimized | Active comparator | Use of optimized attachment to extrude lateral incisor Receives: Device: Optimized attachment |
| Horizontal | Active comparator | Use of horizontal (unbeveled) attachment to extrude lateral incisor Receives: Device: Horizontal attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Aug 2021
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary Lateral Incisor MalocclusionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Lindauer, DDS, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968353
- Sponsor's protocol ID
- HM20021396
- Status last verified
- Jun 2023
- First submitted
- 9 Jul 2021
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Groody JT, Lindauer SJ, Kravitz ND, Carrico CK, Madurantakam P, Shroff B, Darkazanli M, Gardner WG. Effect of clear aligner attachment design on extrusion of maxillary lateral incisors: A multicenter, single-blind randomized clinical trial. Am J Orthod Dentofacial Orthop. 2023 Nov;164(5):618-627. doi: 10.1016/j.ajodo.2023.07.011. Epub 2023 Aug 21.
PubMed 37610383
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors: a Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04968353
- Acronym / sponsor ID
- HM20021396
- Conditions
- Maxillary Lateral Incisor Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Incisally-beveled | Active comparator | Device: Incisally-beveled attachmentUse of incisally-beveled attachment to extrude lateral incisor |
| Gingivally-beveled | Active comparator | Device: Gingivally-beveled attachmentUse of gingivally-beveled attachment to extrude lateral incisor |
| Optimized | Active comparator | Device: Optimized attachmentUse of optimized attachment to extrude lateral incisor |
| Horizontal | Active comparator | Device: Horizontal attachmentUse of horizontal (unbeveled) attachment to extrude lateral incisor |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 16 years or older to be treated with either Comprehensive Invisalign or Invisalign Teen,
- Maxillary lateral incisor requiring 0.3 mm or more extrusion (as determined by ClinCheck),
- Maxillary arch with less than 6 mm of crowding or spacing,
- All teeth present and fully erupted (excluding third molars).
Key exclusion criteria (5 listed)
- Presence of anterior crossbite
- Any missing teeth in the maxillary arch
- Treatment plan includes surgery or extraction of any maxillary teeth,
- Maxillary lateral incisors with pathology or large restorations (crowns)
- Maxillary lateral incisors have a less than 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incisally-beveled attachmentIncisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | Device | Incisally-beveled |
| Gingivally-beveled attachmentGingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | Device | Gingivally-beveled |
| Optimized attachmentOptimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | Device | Optimized |
| Horizontal attachmentHorizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | Device | Horizontal |
Primary outcome
Percent of Vertical Tooth Movement
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37610383Groody JT, Lindauer SJ, Kravitz ND, Carrico CK, Madurantakam P, Shroff B, Darkazanli M, Gardner WG. Effect of clear aligner attachment design on extrusion of maxillary lateral incisors: A multicenter, single-blind randomized clinical trial. Am J Orthod Dentofacial Orthop. 2023 Nov;164(5):618-627. doi: 10.1016/j.ajodo.2023.07.011. Epub 2023 Aug 21.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Lindauer, DDS principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisally-beveled attachment, Gingivally-beveled attachment and Optimized attachment in people with Maxillary Lateral Incisor Malocclusion, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Vertical Tooth Movement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.