Removable Devices in Palatal Expansion

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Removable Devices in Palatal Expansion: a Randomized Open Label Clinical Trial

Conditions
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Palatal Expansion Technique

Intervention / Treatment
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* Device: Elastodontic Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: IOTN index >4; presence of temporomandibular disorders, epilepsy, systemic diseases, periodontal disease, absence of written informed consent signed by parents/legal guardians

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elastodontic removable device<br>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. | Device: Elastodontic Device<br>* Removable device that embraces two dental archs<br>|
| Experimental: Schwarz removable device<br>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. | Device: Elastodontic Device<br>* Removable device that embraces two dental archs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatal first premolars width | To compare the palatal first premolars width in three times | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elastodontic device, growing patients, transversal palatal discrepancies