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| ID | Type | Description | Link |
|---|---|---|---|
| uniri-iskusni-biomed-23-36 | Other Grant/Funding Number | University of Rijeka |
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The goal of this clinical trial is to see if expanding the upper jaw with orthodontic therapy can help improve sleep related breathing problems in children. Parents or caregivers will complete the Pediatric Sleep Questionnaire (PSQ) to assess their child's sleep before and after treatment.
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:
Participants will:
This comprehensive clinical study focuses on evaluating the therapeutic impact of orthodontic maxillary expansion treatment on sleep disorder assessments in children, as reported by their parents or guardians using the Pediatric Sleep Questionnaire (PSQ). Maxillary transverse constriction is a developmental disorder that can adversely affect the orofacial region, potentially influencing breathing patterns during sleep. The primary objective is to investigate whether orthodontic intervention to widen the upper jaw can lead to favorable developmental outcomes in the orofacial region and potentially alleviate sleep-related breathing disorders.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid maxillary expansion group | Active Comparator | expansion of the maxilla with hyrax expander |
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| control | No Intervention | no need for the maxillary expansion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maxillary expansion using hyrax expander | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Facial scan | 3D facial scan of the surface of the face using stereo-photography | from enrollment to the end of treatment at one year on average |
| Dental scan | 3D scan of dentition | from enrollment to the end of treatment at one year on average |
| PSQ questionnaire | Pediatric Sleep Questionnaire (PSQ) filled by the parents / caregivers | from enrollment to the end of treatment at one year on average |
| Measure | Description | Time Frame |
|---|---|---|
| Latero-lateral cephalogram | Cranio-dento-facial characteristics as measured on latero-lateral cephalogram | from enrollment to the end of treatment at one year on average |
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Inclusion Criteria:
narrow maxilla
Exclusion Criteria:
hypodontia, craniodentofacial deformity-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Visnja Katic, Assistant Professor | Contact | 38551345638 | visnja.katic@uniri.hr | |
| Doris Simac, PhD Student | Contact | +385 51 345638 | doris.simac@uniri.hr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine | Recruiting | Rijeka | Primorje-Gorski Kotar County | 51000 | Croatia |
IPD contains identifiable biometric data, and will be disclosed only on reasonable request.
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