- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05848882
Removable Devices in Palatal Expansion
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aq
-
L'Aquila, Aq, Italy, 67100
- Dipartimento MeSVA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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.
|
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.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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