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

NCT07533682 | Not Yet Recruiting

• 2 other identifiers: 133-10-25no ID
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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).

  from the enrollment to the end of expansion at 6 months

Study Arms (2)

group 1

ACTIVE COMPARATOR

with conventional expander

Device: conventional expantion

group 2

EXPERIMENTAL

with S11 expander

Device: maxillary expander with transpalatal strap S11

Interventions

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

group 2

conventional expantion DEVICE

maxillary expansion with conventional expansion design

group 1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aisha Ali Qahtani: lead

Study Sites (1)

Private Clinic

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• ali habib habib, professor

  King Abdulaziz University

  STUDY DIRECTOR

Central Study Contacts

aisha ali qahtani, postgraduate

CONTACT

00966554886261; seenmeem44@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: postgraduate student

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): May 20, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)