An interventional study of novel attachment configuration in Rotation of Tooth, sponsored by Boston University. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Boston University · Not applicable, Interventional, and Treatment
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.
Boston University is the lead sponsor of 270 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
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Exclusion Criteria:
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.
Device: novel attachment configuration
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.
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.
Time frame: baseline, 12 months
Change in buccolingual angulation
Change in buccolingual angulation (tipping) will be measured in degrees, from baseline (T0) to Ti (in degrees).
Time frame: baseline, 12 months
Change in mesiodistal translation
Change in mesiodistal translation will be measured in degrees, from baseline (T0) to Ti (in degrees).
Time frame: 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).
Time frame: baseline, 12 months
Change observed during retention phase
Changes observed during retention phase (post orthodontic therapy - 6months)
Time frame: 12 months, 18 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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