Actively Recruiting
Effect of the Rapid Palatal Expansion Treatment on Reported Sleeping Disorders in Children
Led by University of Rijeka · Updated on 2024-12-10
20
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of Rijeka
Lead Sponsor
U
University of Rijeka Faculty of Dental Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether expanding the upper jaw with orthodontic therapy can improve sleep-related breathing problems in children with a narrow upper jaw. The study will include 20 children with this condition and a control group of children without it. Parents or caregivers will complete the Pediatric Sleep Questionnaire (PSQ) to assess sleep before and after treatment to see if the therapy helps. Participants in the treatment group will receive rapid maxillary expansion using a palatal expander with a hyrax screw, activated twice daily until the desired width is achieved. The control group will not receive this expansion. Before treatment and one year after, children will have 3D facial and dental scans taken. The study uses advanced 3D scanning technology and PSQ questionnaires to evaluate changes and outcomes. During the study, parents or caregivers will fill out the PSQ to assess sleep breathing problems. Researchers will compare 3D facial and dental scans and PSQ results from before and after treatment to measure changes in face structure, palate volume, and sleep disorder symptoms. Additional assessments include latero-lateral cephalogram imaging. The study aims to better understand the effects of maxillary expansion on sleep disorders in children over about one year.
CONDITIONS
Brief Title
Effect of the Palatal Expansion Treatment on Reported Sleeping Disorders in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Narrow maxilla
You will not qualify if you...
- Hypodontia (missing teeth)
- Craniodentofacial deformity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive rapid maxillary expansion using a palatal expander with a hyrax screw, activated twice daily until the required width is achieved according to cast analysis. 3D facial and dental scans are performed before and after treatment, and parents or guardians complete sleep disorder questionnaires.
Baseline visit and follow-up visits as needed over 1 year
Trial Site Locations
Total: 1 location
1
Faculty of Dental Medicine
Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
Actively Recruiting
Research Team
V
Visnja Katic, Assistant Professor
D
Doris Simac, PhD Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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