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Clinical Trials/NCT05848882
NCT05848882CompletedNot Applicable

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

University of L'Aquila2 sites in 1 country70 target enrollmentStarted: March 16, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
2
Primary Endpoint
Palatal first premolars width
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
9 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Palatal first premolars width

Time Frame: 12 months

To compare the palatal first premolars width in three times

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eleonora Ortu

Principal Investigator

University of L'Aquila

Study Sites (2)

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Removable Devices in Palatal Expansion | Clinical Trial