Removable Devices in Palatal Expansion

NCT ID: NCT05848882

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-16
• Study Completion Date: 2023-04-26

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.

Conditions

Palatal Expansion Technique

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elastodontic removable 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.

Group Type: EXPERIMENTAL

Elastodontic Device

Intervention Type: DEVICE

Removable device that embraces two dental archs

Schwarz removable 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.

Group Type: EXPERIMENTAL

Elastodontic Device

Intervention Type: DEVICE

Removable device that embraces two dental archs

Interventions

Elastodontic Device

Removable device that embraces two dental archs

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Ortu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dipartimento MeSVA

L’Aquila, Aq, Italy

Countries

Italy

Other Identifiers

IRB L'Aquila 57/2021-2022

Identifier Type: -

Identifier Source: org_study_id