Effect of the Palatal Expansion Treatment on Reported Sleeping Disorders in Children
NCT ID: NCT06725979
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-04-08
2027-07-31
Brief Summary
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The study will include 20 children with a narrow upper jaw, and a control group of children without this condition. The main questions it aims to answer are:
* Will the 3D scans show significant changes in the face after therapy?
* Will the dental scans show a larger palate volume after treatment?
* Will parents/caregivers notice an improvement in their children's sleep problems after therapy? Researchers will compare 3D facial and dental scans, as well as PSQ results, before and one year after therapy to see if the treatment makes a difference.
Participants will:
* Receive orthodontic treatment to expand the upper jaw.
* Have their sleep related breathing problems assessed by parents or caregivers using the PSQ before and after treatment.
* Have 3D scans of their face and teeth taken before and after treatment.
Detailed Description
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The study will involve 20 patients diagnosed with transverse maxillary constriction, identified through 3D scans of their face and dentition, compared against a control group of individuals without such constriction. Before and one year after treatment, participants will undergo 3D scanning of their facial structure and dentition, complemented by the completion of PSQ questionnaires by their parents or guardians. The study\'s hypotheses propose that following treatment, there will be notable changes in the mid-facial region evident from 3D facial scans, an increase in palate volume as indicated by dental scans, and a moderate improvement in reported sleep disorder symptoms based on parental observations.
The research methodology incorporates non-invasive 3D facial scanning technology, a methodological advancement that allows for precise assessment of facial changes pre-treatment and post-treatment. This approach contrasts with traditional 2D imaging, offering more detailed and accurate data on structural alterations. The study also highlights the utility of PSQ as a validated tool for evaluating sleep disorders in children, avoiding the need for expensive polysomnography.
By utilizing advanced imaging techniques and validated questionnaires, researchers seek to objectively measure treatment outcomes and correlate them with improvements in sleep quality and respiratory function. The study will utilize specialized equipment such as the Bellus 3D facial scanner and the Audaxceph software.
Ultimately, this study aims to enhance our understanding of the relationship between maxillary expansion therapy and sleep disorder improvement in children, potentially paving the way for optimized treatment protocols and improved patient outcomes sleep related breathing problems.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Rapid maxillary expansion group
expansion of the maxilla with hyrax expander
maxillary expansion using hyrax expander
The rapid expansion of the upper jaw will be performed using palatal expander with hyrax screw, which will be activated 2x a day, until the needed width is reached (according to the cast analysis).
control
no need for the maxillary expansion
No interventions assigned to this group
Interventions
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maxillary expansion using hyrax expander
The rapid expansion of the upper jaw will be performed using palatal expander with hyrax screw, which will be activated 2x a day, until the needed width is reached (according to the cast analysis).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
18 Years
ALL
Yes
Sponsors
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University of Rijeka Faculty of Dental Medicine
UNKNOWN
University of Rijeka
OTHER
Responsible Party
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Visnja Katic
Assistant Professor
Locations
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Faculty of Dental Medicine
Rijeka, Primorje-Gorski Kotar County, Croatia
Countries
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Central Contacts
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Facility Contacts
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Department of Orthodontics
Role: primary
Other Identifiers
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uniri-iskusni-biomed-23-36
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RPE PSQ
Identifier Type: -
Identifier Source: org_study_id