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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07533682
Acronym
RCT expansion
Enrollment
30
Registered
2026-04-16
Start date
2026-05-14
Completion date
2027-05-20
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed description

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

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

Sponsors

Aisha Ali Qahtani
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Each patient will be randomly allocated, and the entire patient included in this study will be divided into two groups. One group will be treated using the Smartee aligner expander, and the other group will be treated using the conventional clear aligner expansion. For each patient, the Smartee check will be provided by the same operator using the same standardized expansion protocol, and expansion of the arch will be limited between the first molar up to the canine, excluding the second molar. Moreover, each patient will be instructed to wear their aligners full-time, only removing them for meals and oral hygiene, and to change them every 7 days.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
comparison the effect of S11 expander with conventional onefrom the enrollment to the end of expansion at 6 monthsTo compare the effects of Smartee S11 expander with conventional clear aligner expansion using cone beam computed tomography (CBCT).

Countries

Saudi Arabia

Contacts

CONTACTaisha ali qahtani, postgraduate
seenmeem44@gmail.com00966554886261
STUDY_DIRECTORali habib habib, professor

King Abdulaziz University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026