Effect of the Palatal Expansion Treatment on Reported Sleeping Disorders in Children (RPE PSQ HR)

Effect of the Rapid 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.

Study Overview

• Status: Recruiting
• Conditions: Narrow Maxilla
• Intervention / Treatment: Device: maxillary expansion using hyrax expander

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'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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Visnja Katic, Assistant Professor; Phone Number: 38551345638; Email: visnja.katic@uniri.hr
• Study Contact Backup: Name: Doris Simac, PhD Student; Phone Number: +385 51 345638; Email: doris.simac@uniri.hr

Study Locations

• Croatia
  • Primorsko-goranska
    • Rijeka, Primorsko-goranska, Croatia, 51000
      • Recruiting
      • Faculty of Dental Medicine
      • Contact: Department of Orthodontics; Phone Number: 385 51 345638; Email: visnja.katic@uniri.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

narrow maxilla

Exclusion Criteria:

hypodontia, craniodentofacial deformity-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rapid maxillary expansion group; expansion of the maxilla with hyrax expander	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).; Other Names: rapid palatal expansion
No Intervention: control; no need for the maxillary expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial scan	3D facial scan of the surface of the face using stereo-photography	from enrollment to the end of treatment at one year on average
Dental scan	3D scan of dentition	from enrollment to the end of treatment at one year on average
PSQ questionnaire	Pediatric Sleep Questionnaire (PSQ) filled by the parents / caregivers	from enrollment to the end of treatment at one year on average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latero-lateral cephalogram	Cranio-dento-facial characteristics as measured on latero-lateral cephalogram	from enrollment to the end of treatment at one year on average

Collaborators and Investigators

• Sponsor: University of Rijeka
• Collaborators: University of Rijeka Faculty of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: orthodontics; palatal expansion; facial scan; PSQ; hyrax expander
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: RPE PSQ; uniri-iskusni-biomed-23-36 (Other Grant/Funding Number: University of Rijeka)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD contains identifiable biometric data, and will be disclosed only on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No