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| ID | Type | Description | Link |
|---|---|---|---|
| no ID | Other Grant/Funding Number | Smartee |
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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.
Each patient will be randomly allocated, and the entire patient included in this study will be divided into two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Active Comparator | with conventional expander |
|
| group 2 | Experimental | with S11 expander |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| aisha ali qahtani, postgraduate | Contact | 00966554886261 | seenmeem44@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ali habib habib, professor | King Abdulaziz University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Clinic | Jeddah | Saudi Arabia |
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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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.
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|
| conventional expantion | Device | maxillary expansion with conventional expansion design |
|
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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