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NCT Number: NCT07533682

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Clinic

Jeddah, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

maxillary expander with transpalatal strap S11

Device

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

conventional expantion

Device

maxillary expansion with conventional expansion design

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

aisha ali qahtani, postgraduate

CONTACT

[email protected]

00966554886261

Sponsors and collaborators

Lead sponsor

Aisha Ali Qahtani

Other

Registry information

Acronym: RCT expansion

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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