Rotation of ToothNCT07881146
A Novel Attachment Design for Tooth Rotation With Clear Aligner Therapy
A study testing novel attachment configuration in people with Rotation of Tooth, run by Boston University at 1 site in United States.
Trial summary
Clear aligners are thin, transparent plastic trays that straighten teeth gradually and are a popular, more discreet alternative to traditional braces. To help the traOptionalys grip and move the teeth, dentists usually bond small tooth-colored bumps, called "attachments," onto the front or back surfaces of the teeth. Read more about this study
- Who is it for?
- Ages 22 to 35 years
- Conditions the study is for
- Rotation of Tooth
- What is being tested?
- novel attachment configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged between 22 and 35 years, at the start of their orthodontic treatment, with fully erupted permanent dentition.
- Presence of at least one maxillary or mandibular canines and/or premolar with a clinically significant rotation (>10o) that is considered suitable for correction with clear aligner therapy.
- Mild to moderate crowding or spacing compatible with comprehensive clear aligner treatment, with no need for extractions.
- Good general and oral health without any active periodontal disease or untreated caries, requiring urgent care.
- Patient complaint to willingly wear and able to comply with the aligner wear instructions, follow-up appointments, and study procedures, including digital scanning and patient-reported outcome assessments.
Who cannot join
- Previous orthodontic treatment within the past 5 years, as this is likely to affect tooth movement response or complicate measurement.
- Patients with rotated teeth (canines or premolars) restored with onlays, inlays, or ceramic crowns or extensive restorations that would make it difficult to access or reliably bond attachments to the occlusal surface.
- Need for adjunctive orthodontic appliances (e.g.: Temporary Anchorage Devices (TADs), fixed appliances) that would confound interpretation of the attachments' rotational effect during the T0 to Ti phase.
- Requirement for extractions as part of the planned aligner treatment, particularly involving the premolars or adjacent teeth.
- Active periodontal disease, significant root resorption, or other oral pathologies that contraindicate orthodontic tooth movement.
- Systemic conditions or medications known to affect bone metabolism or orthodontic tooth movement (e.g. bisphosphonates, long-term use of corticosteroids).
- Poor anticipated compliance (e.g.: inability to attend scheduled visits, unwillingness to wear aligners as instructed) as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston University Henry M Goldman School of Dental Medicine, Orthodontic Clinic
Boston, Massachusetts, 02118
Alexandros Tsouknidas, PhD, 617-460-7336, atsouk@bu.edu
About this study
Clear aligners are thin, transparent plastic trays that straighten teeth gradually and are a popular, more discreet alternative to traditional braces. To help the traOptionalys grip and move the teeth, dentists usually bond small tooth-colored bumps, called "attachments," onto the front or back surfaces of the teeth. Although aligners work well for many types of tooth movement, they are much less reliable at turning (rotating) teeth that are twisted out of position, especially rounded teeth such as premolars and canines. Teeth often turn less than planned or tip and shift in unwanted directions. As a result, patients may need extra sets of aligners or a period of conventional braces, which takes away the main reason many people choose aligners.
This study will evaluate the clinical performance of the proposed occlusal attachment designed by the investigators, quantifying rotational correction along with any unintended movements of the target and adjacent teeth. The study is not designed as a device trial of the aligner system, but as an evaluation of a modified attachment configuration within routine clear aligner treatment.
The Primary Objective is to determine the degree of rotational correction that can be achieved in rotated canines and/or premolars using clear aligners with occlusal surface attachments. The Secondary Objective is to assess any unintended tooth movements, including buccolingual tipping, mesiodistal translation and vertical displacement.
- Conditions
- Rotation of Tooth
- Being tested
- novel attachment configuration
- Keywords
- Clear aligners, Tooth tipping, Bite ramps, Translation, Digital treatment plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel attachment configurationDevice
Standard clear aligner therapy using a commercially available system (e.g., Invisalign or equivalent) in which at least one rotated canine or premolar per subject will receive a conventional attachment placed on the occlusal surface and be designated as the index tooth for outcome assessment. No experimental materials will be used; only the attachment position differs from standard practice, and the aligners themselves are FDA- cleared devices manufactured according to existing protocols.
| Study group | Role | What they receive |
|---|---|---|
| clear aligners with occlusal surface attachments | Experimental | Participants will receive clear aligner treatment incorporating the investigational attachment design within the Prosthodontics Department by a clinician with appropriate training and experience in clear aligner therapy. Receives: Device: novel attachment configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tooth rotation
Change in tooth rotation will be measured in degrees, from baseline (T0) to complete rotational correction (Ti), using standardized angular measurements on digital models around the tooth's long axis.
Measured: baseline, 12 months
Secondary outcomes (4)
Change in buccolingual angulation
Change in buccolingual angulation (tipping) will be measured in degrees, from baseline (T0) to Ti (in degrees).
Measured: baseline, 12 months
Change in mesiodistal translation
Change in mesiodistal translation will be measured in degrees, from baseline (T0) to Ti (in degrees).
Measured: baseline, 12 months
Change in vertical position (intrusion/extrusion)
Change in vertical position (intrusion/extrusion) will be measured in degrees, from baseline (T0) to Ti (in degrees).
Measured: baseline, 12 months
Change observed during retention phase
Changes observed during retention phase (post orthodontic therapy - 6months)
Measured: 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotation of ToothStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandros Tsouknidas, PhD, Principal investigator, Boston University Henry M Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881146
- Sponsor's protocol ID
- H-47374
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Attachment Design for Tooth Rotation With Clear Aligner Therapy
- ClinicalTrials.gov ID
- NCT07881146
- Acronym / sponsor ID
- H-47374
- Conditions
- Rotation of Tooth
- Keywords
- Clear aligners, Tooth tipping, Bite ramps, Translation, Digital treatment plan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clear aligners are thin, transparent plastic trays that straighten teeth gradually and are a popular, more discreet alternative to traditional braces. To help the traOptionalys grip and move the teeth, dentists usually bond small tooth-colored bumps, called "attachments," onto the front or back surfaces of the teeth. Although aligners work well for many types of tooth movement, they are much less reliable at turning (rotating) teeth that are twisted out of position, especially rounded teeth such as premolars and canines. Teeth often turn less than planned or tip and shift in unwanted directions. As a result, patients may need extra sets of aligners or a period of conventional braces, which takes away the main reason many people choose aligners.
This study will evaluate the clinical performance of the proposed occlusal attachment designed by the investigators, quantifying rotational correction along with any unintended movements of the target and adjacent teeth. The study is not designed as a device trial of the aligner system, but as an evaluation of a modified attachment configuration within routine clear aligner treatment.
The Primary Objective is to determine the degree of rotational correction that can be achieved in rotated canines and/or premolars using clear aligners with occlusal surface attachments. The Secondary Objective is to assess any unintended tooth movements, including buccolingual tipping, mesiodistal translation and vertical displacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clear aligners with occlusal surface attachments | Experimental | Device: novel attachment configurationParticipants will receive clear aligner treatment incorporating the investigational attachment design within the Prosthodontics Department by a clinician with appropriate training and experience in clear aligner therapy. |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged between 22 and 35 years, at the start of their orthodontic treatment, with fully erupted permanent dentition.
- Presence of at least one maxillary or mandibular canines and/or premolar with a clinically significant rotation (>10o) that is considered suitable for correction with clear aligner therapy.
- Mild to moderate crowding or spacing compatible with comprehensive clear aligner treatment, with no need for extractions.
- Good general and oral health without any active periodontal disease or untreated caries, requiring urgent care.
- Patient complaint to willingly wear and able to comply with the aligner wear instructions, follow-up appointments, and study procedures, including digital scanning and patient-reported outcome assessments.
Key exclusion criteria (7 listed)
- Previous orthodontic treatment within the past 5 years, as this is likely to affect tooth movement response or complicate measurement.
- Patients with rotated teeth (canines or premolars) restored with onlays, inlays, or ceramic crowns or extensive restorations that would make it difficult to access or reliably bond attachments to the occlusal surface.
- Need for adjunctive orthodontic appliances (e.g.: Temporary Anchorage Devices (TADs), fixed appliances) that would confound interpretation of the attachments' rotational effect during the T0 to Ti phase.
- Requirement for extractions as part of the planned aligner treatment, particularly involving the premolars or adjacent teeth.
- Active periodontal disease, significant root resorption, or other oral pathologies that contraindicate orthodontic tooth movement.
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 |
|---|---|---|
| novel attachment configurationStandard clear aligner therapy using a commercially available system (e.g., Invisalign or equivalent) in which at least one rotated canine or premolar per subject will receive a conventional attachment placed on the occlusal surface and be designated as the index tooth for outcome assessment. No experimental materials will be used; only the attachment position differs from standard practice, and the aligners themselves are FDA- cleared devices manufactured according to existing protocols. | Device | clear aligners with occlusal surface attachments |
Primary outcome
Change in tooth rotation
Time frame: baseline, 12 months
Change in tooth rotation will be measured in degrees, from baseline (T0) to complete rotational correction (Ti), using standardized angular measurements on digital models around the tooth's long axis.
4 secondary outcomes
Change in buccolingual angulation
Time frame: baseline, 12 months
Change in mesiodistal translation
Time frame: baseline, 12 months
Change in vertical position (intrusion/extrusion)
Time frame: baseline, 12 months
Change observed during retention phase
Time frame: 12 months, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Rotation of Tooth
Enrolling by invitation
The Predictability of Directly Printed Versus Thermoformed Clear Aligners
Class I Malocclusion, Crowded Teeth
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.
Alexandros Tsouknidas, PhD principal investigator
Boston University Henry M Goldman School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel attachment configuration in people with Rotation of Tooth, run by Boston 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Tsouknidas, PhD (617.460.7336, atsouk@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tooth rotation (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.