Faculty of Dental Medicine
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Location status: Recruiting
NCT Number: NCT06725979
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.
Interested in participating?
Request Info2 year–18 year
All sexes
Interventional
Not applicable
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
narrow maxilla
Exclusion criteria
hypodontia, craniodentofacial deformity-
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
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
Time frame: from enrollment to the end of treatment at one year on average
3D scan of dentition
Time frame: from enrollment to the end of treatment at one year on average
Pediatric Sleep Questionnaire (PSQ) filled by the parents / caregivers
Time frame: from enrollment to the end of treatment at one year on average
Cranio-dento-facial characteristics as measured on latero-lateral cephalogram
Contact information is provided by the study sponsor or research team.
Doris Simac, PhD Student
CONTACT
Visnja Katic, Assistant Professor
CONTACT
University of Rijeka
Other
Effect of the Rapid Palatal Expansion Treatment on Reported Sleeping Disorders in Children
Acronym: RPE PSQ HR
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.
Published trials that share one or more normalized conditions with this study.
NCT07362160
Malocclusion, Narrow Maxilla
Baghdad, Al-Rusafa, Bab Al-moadham, Iraq
View Trial DetailsNCT06449014
Narrow Maxilla
Anderlecht, Brussels Capital, Belgium
View Trial DetailsNCT06662279
Behavior, Crowding
Laguna Hills, California, United States
View Trial Details