Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: maxillary expander with transpalatal strap S11, conventional expantion.
- Who it may be relevant to
- Registry conditions: Crossbite (Posterior), Expansion of Maxillary Arch, Clear Aligner Appliance. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device maxillary 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 - Device conventional expantion
maxillary expansion with conventional expansion design
Primary outcome measures
- comparison the effect of S11 expander with conventional one [Time frame: from the enrollment to the end of expansion at 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- Private Clinic — Jeddah
Identifiers
NCT: NCT07533682 · 133-10-25 · no ID