None listed
Conditions
Brief summary
A 2-arm randomised clinically controlled trial to determine if there is a difference in palatal volume and surface area between conventional expander appliance and appliances fabricated by a clear aligner company. The study intervention includes the placement of rapid palatal expander appliances or clear aligner expander appliances. The rapid maxillary expanders are adjusted at home by the participant using a key which expands the device; the clear aligner expanders are removed and replaced at home with sequentially expanded appliances. The palate is then scanned and the palatal volume measured digitally. The palatal volume is used to determine if there are any significant differences in expansion of the palatal between the appliances..
Interventions
Clear aligner expanders are removed and replaced at home with sequentially expanded appliances, oral hygiene practices are not altered when using clear aligners.
The intervention will be delivered by orthodontists and orthodontic registrars. The duration of the intervention is 273 days +/- 3 days from the first visit after enrolment and will take place at Sydney Dental Hospital Orthodontic Department
Clear aligner appliances will not seat if the participant has not adhered to the treatment plan.
Clear aligner expanders are removed and replaced at home with sequentially expanded appliances, oral hygiene practices are not altered when using clear aligners. The intervention will be delivered by orthodontists and orthodontic registrars. The duration of the intervention is 273 days +/- 3 days from the first visit after enrolment and will take place at Sydney Dental Hospital Orthodontic Department Clear aligner appliances will not seat if the participant has not adhered to the treatment plan. Participants will be given a self-compliance survey at each visit following the first visit.
Sponsors
ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO LTD (Shanghai Smartee Denti-Technology Co., Ltd)
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
9 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Active and pre-pubertal growth (Cervical maturation stage CS 2-3.) 2. Erupted maxillary first premolars and permanent first molars. 3. Evidence of dental maxillary transverse discrepancy: a. Md excess >2mm. b. Unilateral or bilateral transverse crossbite. c. Medially tipped maxillary clinical crowns. 4. Willingness to provide informed consent (parent/guardian) and comply with the study requirements.
Exclusion criteria
1. Syndromic individuals (including cleft lip and palate (CLP)) 2. Deciduous first molars, severe crowding, hypodontia. 3. Temporomandibular joint disorder signs and symptoms 4. Previous Orthodontic treatment 5. Circumstances/conditions which may interfere with the participant’s ability to give informed consent.
Outcome results
None listed