Health TrialsbyHealthPanel

Effect of the Palatal Expansion Treatment on Reported Sleeping Disorders in Children

ConditionNarrow Maxilla
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorUniversity of Rijeka

About this trial

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:

* 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Rapid maxillary expansion groupActive comparator 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Facial scan

3D facial scan of the surface of the face using stereo-photography

Time frame
from enrollment to the end of treatment at one year on average
2

Dental scan

3D scan of dentition

Time frame
from enrollment to the end of treatment at one year on average
3

PSQ questionnaire

Pediatric Sleep Questionnaire (PSQ) filled by the parents / caregivers

Time frame
from enrollment to the end of treatment at one year on average

Secondary outcomes

1

Latero-lateral cephalogram

Cranio-dento-facial characteristics as measured on latero-lateral cephalogram

Time frame
from enrollment to the end of treatment at one year on average

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rijeka

Lead sponsor

University of Rijeka Faculty of Dental Medicine

Collaborator

Source ClinicalTrials.gov
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