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NCT Number: NCT06725979

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

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.

Recruiting

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Key information

Conditions

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location status: Recruiting

Location contact

Department of Orthodontics

CONTACT

[email protected]

385 51 345638

About this study

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'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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

narrow maxilla

Exclusion criteria

hypodontia, craniodentofacial deformity-

Treatment and study plan

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).

Other names: rapid palatal expansion

Primary outcomes

  1. Facial scan

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

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

  2. Dental scan

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

    3D scan of dentition

  3. PSQ questionnaire

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

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

Secondary outcomes

  1. Latero-lateral cephalogram

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Doris Simac, PhD Student

CONTACT

[email protected]

+385 51 345638

Visnja Katic, Assistant Professor

CONTACT

[email protected]

38551345638

Sponsors and collaborators

Lead sponsor

University of Rijeka

Other

Registry information

Official study title

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

Acronym: RPE PSQ HR

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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