Removable Devices in Palatal Expansion

Palatal Expansion Technique Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05848882
• Other study ID #: IRB L'Aquila 57/2021-2022
• Status: Completed
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: April 26, 2023

Study information

• Verified date: May 2023
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 26, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Palatal Expansion Technique

Intervention

Device:
• Elastodontic Device
Removable device that embraces two dental archs

Locations

Country	Name	City	State
Italy	Dipartimento MeSVA	L'Aquila	Aq

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palatal first premolars width	To compare the palatal first premolars width in three times	12 months