Removable Devices in Palatal Expansion
- Conditions
- Palatal Expansion Technique
- Interventions
- Device: Elastodontic Device
- Registration Number
- NCT05848882
- Lead Sponsor
- University of L'Aquila
- Brief Summary
The goal of this clinical trial si to compare two removable devices used to treat the transversal discrepancies in growing patients.
The main questions it aims to answer are:
* the efficacy of the two devices in the palatal expansion
* the neuromuscolar effects developed on the stomatognatic system Participants will be instructed in the use and maintenance of the devices and will be checked every 15-30 days for one year.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
skeletal class I relationship, molar class I relationship; complete eruption of upper first premolars ; presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index)
IOTN index >4; presence of temporomandibular disorders, epilepsy, systemic diseases, periodontal disease, absence of written informed consent signed by parents/legal guardians
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Schwarz removable device Elastodontic Device Patients in this group will be treat with a Schwarz removable device constructed individually by the dental technician.This device has a resin baseplate with an activation screw in the center and Adams hooks on the upper first molars and it works by turning the expansion screw in the center of the palate one-quarter turn, once or twice a month by the ortodontist. This appliance is worn overnight and some hours during the day (totally 16 hours).The distance between the palatal cusps of the first upper premolars will be taken at T0( before the start of the therapy), at T1 (after six months)and at T2 (after one month). All the dental recors will be taken by the same operator with an intraoral scanner 3D. Elastodontic removable device Elastodontic Device Patients in this group will be treat with an elastodontic device adapted to the patient according to the shape of the dental arches. This device is similar to a mouthguard and embraces both dental arches. This appliance is worn overnight and the patient will be checked every month. The distance between the palatal cusps of the first upper premolars will be taken at T0( before the start of the therapy), at T1 (after six months)and at T2 (after one month). All the dental recors will be taken by the same operator with an intraoral scanner 3D.
- Primary Outcome Measures
Name Time Method Palatal first premolars width 12 months To compare the palatal first premolars width in three times
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dipartimento MeSVA
🇮🇹L'Aquila, Aq, Italy