- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456917
Effects of BREA and MFT Expansion Appliances on Upper Airway Dimensions
Effects of BREA and MFT Expansion Appliances on Upper Airway Dimensions, Hyoid Bone Position and Palatal Morphology in Growing Children
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zabrze, Poland
- Silesian Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children aged 4 to 12 years at baseline. Patients in primary or mixed dentition stage.
Availability of complete orthodontic diagnostic records at two time points, including:
lateral cephalometric radiograph posteroanterior cephalometric radiograph dental models suitable for digital analysis For treated groups: orthodontic expansion performed with either BREA or MFT according to routine clinical indications.
For control group: patients who underwent full orthodontic diagnostics but did not initiate orthodontic treatment during the observation period.
Good general health without systemic conditions known to significantly affect craniofacial growth.
Exclusion Criteria:
Presence of cleft lip and/or palate. Previous orthodontic treatment prior to baseline records. Presence of generalized spacing or diastema that could affect transverse measurements.
Incomplete or missing radiographic records. Poor quality radiographs preventing reliable cephalometric analysis. Poor quality dental models, including artifacts on the palatal surface or indistinct gingival margins.
Craniofacial syndromes or conditions known to significantly alter craniofacial development.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MFT Expansion Group
Participants received orthodontic treatment with a maxillary fixed three screw palatal expander (MFT) as part of routine clinical care.
The appliance consisted of acrylic splints on the maxillary posterior teeth connected by a central Hyrax type screw and two auxiliary screws.
The central screw was activated once daily and the lateral screws every five days according to the clinical protocol.
Cephalometric radiographs and digital dental models obtained before and after treatment were analyzed to assess airway, hyoid, and palatal changes.
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A fixed orthodontic maxillary expansion device anchored to posterior teeth with acrylic splints and incorporating one central Hyrax type expansion screw and two auxiliary transverse screws.
The central screw was activated once daily (up to 28 turns) and the lateral screws once every five days (up to 10 turns) according to the clinical protocol.
The appliance was used in growing children to achieve transverse maxillary expansion.
Treatment and imaging were part of routine orthodontic care.
Other Names:
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Experimental: BREA Expansion Group
Participants were treated with a removable bimaxillary expansion appliance (BREA) worn full time except during meals and oral hygiene.
The device incorporated two expansion screws, one in the maxillary arch and one in the mandibular arch, both activated once weekly in the horizontal plane.
Treatment followed routine orthodontic indications.
Pre and post observation cephalometric radiographs and digital models were analyzed to evaluate changes in airway dimensions, hyoid position, and palatal morphology.
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A removable orthodontic appliance designed for simultaneous maxillary and mandibular transverse expansion.
The device contains two expansion screws, one positioned in the maxillary arch and one in the mandibular arch.
It was worn full time except during meals and oral hygiene.
Both screws were activated once weekly in the horizontal plane according to the treatment protocol.
The appliance was used in growing children as part of standard orthodontic management.
Other Names:
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No Intervention: Untreated Control Group
Participants underwent standard orthodontic diagnostics at two time points but did not receive expansion therapy.
These patients declined treatment and were followed observationally.
Paired cephalometric radiographs and digital dental models were analyzed over the observation interval to provide a reference for natural growth related changes in airway parameters, hyoid position, and palatal morphology.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in upper airway and hyoid positional measurements on cephalometry
Time Frame: Baseline and post-treatment observation period (mean approximately 6 to 12 months, depending on individual treatment duration)
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The primary outcome is the longitudinal change in selected upper airway and hyoid bone parameters measured on calibrated lateral and posteroanterior cephalometric radiographs.
Key variables include piriform aperture width (NCULPA-NCURPA), hypopharyngeal airway dimension at C4ia (Z5-Z6), and the linear distance between the hyoid bone and mandibular symphysis (rGn-H).
Values are calculated as the difference between post-treatment and baseline measurements and compared between study arms.
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Baseline and post-treatment observation period (mean approximately 6 to 12 months, depending on individual treatment duration)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in palatal morphology and transverse interdental dimensions
Time Frame: Baseline and post-treatment observation period (mean approximately 6 to 12 months, depending on individual treatment duration)
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Secondary outcomes include three dimensional changes in palatal morphology and dental arch width derived from digital models.
Assessed variables comprise palatal volume (PV), palatal surface area (PSA), palatal depth (PD1, PD2), palatal length (PL), and transverse interdental distances in the maxillary and mandibular arches (3+3, 4+4, 5+5, 6+6 and 3-3, 4-4, 5-5, 6-6).
Measurements are calculated as post minus pre values normalized to the observation period and compared between study arms.
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Baseline and post-treatment observation period (mean approximately 6 to 12 months, depending on individual treatment duration)
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Change in piriform aperture transverse width
Time Frame: Baseline and post-treatment observation period (mean approximately 6 to 12 months, depending on individual treatment duration)
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This secondary outcome evaluates the longitudinal change in the transverse dimension of the piriform aperture measured on calibrated posteroanterior cephalometric radiographs.
The primary variable is NCULPA-NCURPA.
Values are calculated as the difference between post-observation and baseline measurements and compared across study arms to assess the effect of orthodontic expansion on the bony nasal inlet.
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Baseline and post-treatment observation period (mean approximately 6 to 12 months, depending on individual treatment duration)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PCN/0022/KB1/11/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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