Crossbite (Posterior)RCT expansionNCT07533682
Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial
A study testing maxillary expander with transpalatal strap S11 and conventional expantion in people with Crossbite (Posterior) and Expansion of Maxillary Arch, run by Aisha Ali Qahtani at 1 site in Saudi Arabia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Crossbite (Posterior), Expansion of Maxillary Arch, Clear Aligner Appliance
- What is being tested?
- maxillary expander with transpalatal strap S11 and conventional expantion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 14 May 2026to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- maxillary expander with transpalatal strap S11, conventional expantion
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary expander with transpalatal strap S11Device
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 expantionDevice
maxillary expansion with conventional expansion design
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | with conventional expander Receives: Device: conventional expantion |
| group 2 | Experimental | with S11 expander Receives: Device: maxillary expander with transpalatal strap S11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from the enrollment to the end of expansion at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start14 May 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crossbite (Posterior)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aisha Ali Qahtani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aisha Ali Qahtani, King Abdulaziz University
- Investigators
- ali habib habib, professor, Study director, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533682
- Sponsor's protocol ID
- 133-10-25
- Other IDs
- no ID
- Acronym
- RCT expansion
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07533682
- Acronym / sponsor ID
- RCT expansion / 133-10-25
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aisha Ali QahtaniUniversity, hospital or other
- Study start
- 14 May 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Device: conventional expantionwith conventional expander |
| group 2 | Experimental | Device: maxillary expander with transpalatal strap S11with S11 expander |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maxillary expander with transpalatal strap S11new 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 | Device | group 2 |
| conventional expantionmaxillary expansion with conventional expansion design | Device | group 1 |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ali habib habib, professor study director
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary expander with transpalatal strap S11 and conventional expantion in people with Crossbite (Posterior) and Expansion of Maxillary Arch, run by Aisha Ali Qahtani at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aisha ali qahtani, postgraduate (00966554886261, seenmeem44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison the effect of S11 expander with conventional one (time frame: from the enrollment to the end of expansion at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.