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Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial

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Summary

The NIH's ClinicalTrials.gov has registered a randomized clinical trial (NCT07533682) comparing maxillary dental expansion using Smartee Clear Aligners with and without the S11 expander. The trial will use cone beam computed tomography (CBCT) to evaluate orthodontic expansion and tooth movement in patients with posterior crossbite requiring maxillary arch expansion.

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What changed

NIH's ClinicalTrials.gov has added registration NCT07533682 for a randomized clinical trial evaluating Smartee S11 expander combined with clear aligners versus conventional clear aligner expansion for maxillary arch treatment.

For compliance purposes, this study registration indicates an active clinical investigation of a dental/oral health device. Clinical investigators and healthcare providers involved in orthodontic research should note this trial for awareness, though it does not create immediate compliance obligations for non-participating entities.

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial

N/A NCT07533682 Kind: NA Apr 16, 2026

Abstract

To compare the effects of Smartee S11 expander with conventional clear aligner expansion using cone beam computed tomography (CBCT).

The secondary objective is to evaluate the degree of orthodontic expansion and the type of tooth movement achieved with Smartee aligners on the maxillary arch.

Conditions: Crossbite (Posterior), Expansion of Maxillary Arch, Clear Aligner Appliance

Interventions: maxillary expander with transpalatal strap S11, conventional expantion

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533682

Who this affects

Applies to
Healthcare providers Patients Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Medical device research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
FDA 21 CFR Part 11
Topics
Medical Devices Pharmaceuticals

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