Removable Devices in Palatal Expansion

NCT05848882 | Completed

• 1 other identifier: IRB L'Aquila 57/2021-2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

elastodontic device; growing patients; transversal palatal discrepancies

Outcome Measures

Primary Outcomes (1)

• Palatal first premolars width

  To compare the palatal first premolars width in three times

  12 months

Study Arms (2)

Elastodontic removable device

EXPERIMENTAL

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

Schwarz removable device

EXPERIMENTAL

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

Interventions

Elastodontic Device DEVICE

Removable device that embraces two dental archs

Elastodontic removable device; Schwarz removable device

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• IOTN index \>4; presence of temporomandibular disorders, epilepsy, systemic diseases, periodontal disease, absence of written informed consent signed by parents/legal guardians

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

Dipartimento MeSVA

L’Aquila, Aq, 67100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: March 16, 2023
• Primary Completion: April 18, 2023
• Study Completion: April 26, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)