Actively Recruiting
Impact of Functional Appliances on 3D Craniodentofacial Characteristics and Sleep Related Breathing Disorders in Children with Retrognathic Mandible
Led by University of Rijeka · Updated on 2024-12-10
20
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children aged 10 to 14 years who have a retrognathic mandible, a condition where the lower jaw is positioned backward. The trial aims to evaluate how functional appliance therapy using the Twin Block device affects 3D craniodentofacial features and reported sleep-related breathing disorders. This research also includes assessing the impact of the therapy on upper airway dimensions and sleep problems, which are important for overall child growth and development. Participants will receive the Twin Block functional appliance proposed after diagnostics, which they will wear for about one year. Three-dimensional facial scans will be taken before treatment, including at rest and with the mandible moved forward using the Fraenkel maneuver, as well as after the treatment ends. Caregivers will complete the Pediatric Sleep Questionnaire (PSQ) before and after treatment to evaluate perceived changes in sleep-related breathing issues. Additionally, lateral cephalogram X-rays will be taken from enrollment to the end of treatment to support the assessment. During the study, children will undergo detailed facial scans and X-rays to monitor changes in their facial structure and airway. Caregivers will provide input through questionnaires to assess sleep breathing problems. Researchers will compare initial scans and predicted treatment outcomes with actual results to evaluate therapy effectiveness. The total participation period is approximately one year, during which the team will closely observe facial growth, airway changes, and sleep-related symptoms to understand the therapy's influence.
CONDITIONS
Brief Title
3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Retrognathic mandible with increased overjet
- Age between 10 and 14 years
You will not qualify if you...
- Presence of craniodentofacial deformities that affect eligibility for functional appliance therapy or study participation
- Age outside the 10 to 14 years range
- Any condition preventing participation in a year-long functional appliance treatment study or completion of required scans and questionnaires
- Gender is not restricted but all genders are eligible
- Healthy volunteers are not included as participants must have retrognathic mandible
- Other unspecified medical conditions interfering with study participation are excluded if noted by investigators
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 - One year
Participants use the functional appliance Twin block for one year to improve jaw alignment and related breathing functions. 3D facial scans and questionnaires are completed before and after treatment to assess progress.
3 visits (for 3D facial scans and questionnaires)
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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