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

April 10, 2026 updated by: Aisha Ali Qahtani

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Each patient will be randomly allocated, and the entire patient included in this study will be divided into two groups.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1- healthy cooperative female and male patients who will undergo maxillary expansion with Smartee aligners, A young adult/adult patients starting from age of 18 up to 35 years old.

    2- patients with maxillary compression of non-skeletal origin, moderate dental crowding in the upper arch (4-8mm). 3- patients with unilateral or bilateral crossbite, patients will be treated with intermaxillary elastics without distalization or mesialization of the dental arches.

    4- patients with sufficient clinical crown height (greater than 4 mm), no mesial rotation of the upper first molar. 5- there is good compliance during the treatment (wearing aligners for 20 hours per day).

    6- good quality x-rays with appropriate visualization of landmarks and control of head rotation. 7- absence of periodontal disease, and absence of previous prosthodontic treatments of the upper molars.

Exclusion Criteria:

  • 1- signs and/or symptoms of temporomandibular abnormalities (TMDs). 2- active periodontal disease. 3- prosthodontic rehabilitations of the maxillary molar or ankylosed teeth, and endodontic treatments of the maxillary molars. 4- patients requiring orthognathic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
with conventional expander
Device: conventional expantion
maxillary expansion with conventional expansion design
Experimental: group 2
with S11 expander
Device: maxillary expander with transpalatal strap S11
new feature incorporated into the aligners, called trans Palatal bar (S11-Horizontal Arch Expander) which is an invisible clear trans Palatal expander customized to the patient through digital design and individual cutting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison the effect of S11 expander with conventional one
Time Frame: from the enrollment to the end of expansion at 6 months
To compare the effects of Smartee S11 expander with conventional clear aligner expansion using cone beam computed tomography (CBCT).
from the enrollment to the end of expansion at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aisha Ali Qahtani

Investigators

  • Study Director: ali habib habib, professor, King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 14, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

May 20, 2027

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 133-10-25
  • No ID (Other Grant/Funding Number: Smartee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The dataset contains sensitive patient information, and sharing it could compromise participant confidentiality despite de-identification efforts. Access to the data is therefore restricted in accordance with institutional review board (IRB) guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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