Novel Attachment Design for Malocclusion

AT
LA
Overseen ByLirin A Thomas
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Boston University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AT

Alexandros Tsouknidas, PhD

Principal Investigator

Boston University Henry M Goldman School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for people who need clear aligner treatment to rotate twisted canine or premolar teeth. Participants should have malocclusion (misaligned teeth) and be suitable candidates for clear aligners.

Inclusion Criteria

I am 22 to 35 years old and have all my permanent teeth.
My teeth are mildly to moderately crowded or spaced and I don't need extractions.
I have good overall and dental health with no urgent dental problems.
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Exclusion Criteria

I do not have gum disease or serious dental problems that prevent tooth movement.
Need for adjunctive orthodontic appliances (e.g., Temporary Anchorage Devices, fixed appliances) that would confound interpretation of attachments' rotational effect during T0 to Ti phase
Poor anticipated compliance (e.g., inability to attend scheduled visits, unwillingness to wear aligners as instructed) as judged by investigator
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What Are the Treatments Tested in This Trial?

Interventions

  • Novel Attachment Configuration

Trial Overview

The study tests a new type of small bump (attachment) placed on the biting surface of certain teeth, used with clear aligners, to see if it helps turn rotated canines or premolars more effectively than standard attachments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: clear aligners with occlusal surface attachmentsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials
494
Recruited
9,998,000+