Clinical trial NCT06725979: Effect of the Palatal Expansion Treatment on Reported Sleeping Disorders in Children
Official title: Effect of the Rapid Palatal Expansion Treatment on Reported Sleeping Disorders in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Narrow Maxilla
Keywords: palatal expansion
PSQ
facial scan
orthodontics
hyrax expander
Lead sponsor: University of Rijeka
Sponsor class: OTHER
Collaborators: name: University of Rijeka Faculty of Dental Medicine
First posted: 2024-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This comprehensive clinical study focuses on evaluating the therapeutic impact of orthodontic maxillary expansion treatment on sleep disorder assessments in children, as reported by their parents or guardians using the Pediatric Sleep Questionnaire (PSQ). Maxillary transverse constriction is a developmental disorder that can adversely affect the orofacial region, potentially influencing breathing patterns during sleep. The primary objective is to investigate whether orthodontic intervention to widen the upper jaw can lead to favorable developmental outcomes in the orofacial region and potentially alleviate sleep-related breathing disorders.

The study will involve 20 patients diagnosed with transverse maxillary constriction, identified through 3D scans of their face and dentition, compared against a control group of individuals without such constriction. Before and one year after treatment, participants will undergo 3D scanning of their facial structure and dentition, complemented by the completion of PSQ questionnaires by their parents or guardians. The study\&#39;s hypotheses propose that following treatment, there will be notable changes in the mid-facial region evident from 3D facial scans, an increase in palate volume as indicated by dental scans, and a moderate improvement in reported sleep disorder symptoms based on parental observations.

The research methodology incorporates non-invasive 3D facial scanning technology, a methodological advancement that allows for precise assessment of facial changes pre-treatment and post-treatment. This approach contrasts with traditional 2D imaging, offering more detailed and accurate data on structural alterations. The study also highlights the utility of PSQ as a validated tool for evaluating sleep disorders in children, avoiding the need for expensive polysomnography.

By utilizing advanced imaging techniques and validated questionnaires, researchers seek to objectively measure treatment outcomes and correlate them with improvements in sleep quality and respiratory function. The study will utilize specialized equipment such as the Bellus 3D facial scanner and the Audaxceph software.

Ultimately, this study aims to enhance our understanding of the relationship between maxillary expansion therapy and sleep disorder improvement in children, potentially paving the way for optimized treatment protocols and improved patient outcomes sleep related breathing problems.

Eligibility criteria: Inclusion Criteria:

narrow maxilla

Exclusion Criteria:

hypodontia, craniodentofacial deformity-

Primary outcomes:
measure: Facial scan
timeFrame: from enrollment to the end of treatment at one year on average
measure: Dental scan
timeFrame: from enrollment to the end of treatment at one year on average
measure: PSQ questionnaire
timeFrame: from enrollment to the end of treatment at one year on average
Secondary outcomes:
measure: Latero-lateral cephalogram
timeFrame: from enrollment to the end of treatment at one year on average
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Faculty of Dental Medicine
state: Primorsko-goranska
Study officials:
References: