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

NCT06725979 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-10

No results posted yet for this study

Summary

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.

Conditions

  • Narrow Maxilla

Interventions

DEVICE

maxillary expansion using hyrax expander

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).

Sponsors & Collaborators

  • University of Rijeka Faculty of Dental Medicine

    collaborator UNKNOWN

  • University of Rijeka

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2025-10-31
Completion
2027-07-31

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725979 on ClinicalTrials.gov