Removable Devices in Palatal Expansion

May 11, 2023 updated by: Eleonora Ortu, University of L'Aquila

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Aq
      • L'Aquila, Aq, Italy, 67100
        • Dipartimento MESVA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Elastodontic Device
Removable device that embraces two dental archs
Experimental: 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.
Device: Elastodontic Device
Removable device that embraces two dental archs

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Actual)

April 18, 2023

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB L'Aquila 57/2021-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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