Removable Devices in Palatal Expansion

Sponsor

University of L'Aquila (Other)

Overall Status

Completed

CT.gov ID

NCT05848882

Collaborator

(none)

Enrollment

Location

Arms

1.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Palatal Expansion Technique	Device: Elastodontic Device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 16, 2023

Actual Primary Completion Date :

Apr 18, 2023

Actual Study Completion Date :

Apr 26, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Palatal first premolars width [12 months]
To compare the palatal first premolars width in three times

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dipartimento MeSVA	L'Aquila	Aq	Italy	67100

Sponsors and Collaborators

University of L'Aquila

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eleonora Ortu, Principal Investigator, University of L'Aquila

ClinicalTrials.gov Identifier:

NCT05848882

Other Study ID Numbers:

IRB L'Aquila 57/2021-2022

First Posted:

May 8, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eleonora Ortu, Principal Investigator, University of L'Aquila

elastodontic device

growing patients

transversal palatal discrepancies

Study Results

No Results Posted as of May 12, 2023