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Not yet recruitingNCT07533682RCT expansionUpdated Apr 16, 2026

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

An interventional study of maxillary expander with transpalatal strap S11 and conventional expantion in Crossbite (Posterior), Expansion of Maxillary Arch and Clear Aligner Appliance, sponsored by Aisha Ali Qahtani. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Aisha Ali Qahtani · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Crossbite (Posterior)
  • Expansion of Maxillary Arch
  • Clear Aligner Appliance

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03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    group 1

    with conventional expander

    Device: conventional expantion

  • Experimental
    group 2

    with S11 expander

    Device: maxillary expander with transpalatal strap S11

Interventions

  • Devicemaxillary 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

  • Deviceconventional expantion

    maxillary expansion with conventional expansion design

05

What researchers measure

Primary outcomes

  1. comparison the effect of S11 expander with conventional one

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

    Time frame: from the enrollment to the end of expansion at 6 months

06

Study locations

1 site
  • Private Clinic
    Jeddah, Saudi Arabia
07

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07533682
Lead sponsor
Aisha Ali Qahtani
Responsible party
Aisha Ali Qahtani (postgraduate student, King Abdulaziz University) — Sponsor-investigator
First posted
Apr 16, 2026
Start date
May 14, 2026 (estimated)
Primary completion
Dec 20, 2026 (estimated)
Completion
May 20, 2027 (estimated)
Last update
Apr 16, 2026

Study contacts

aisha ali qahtani, postgraduate
Contact
seenmeem44@gmail.com
00966554886261
ali habib habib, professor
study director · King Abdulaziz University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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