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

NCT06725979 | Recruiting DMC

• 2 other identifiers: RPE PSQuniri-iskusni-biomed-23-36
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Narrow Maxilla

Keywords

palatal expansion; PSQ; facial scan; orthodontics; hyrax expander

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Latero-lateral cephalogram

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

Study Arms (2)

Rapid maxillary expansion group

ACTIVE COMPARATOR

expansion of the maxilla with hyrax expander

Device: maxillary expansion using hyrax expander

control

NO INTERVENTION

no need for the maxillary expansion

Interventions

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).

Also known as: rapid palatal expansion

Rapid maxillary expansion group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• narrow maxilla

You may not qualify if:

• hypodontia, craniodentofacial deformity-

Sponsors & Collaborators

• University of Rijeka: lead
• University of Rijeka Faculty of Dental Medicine: collaborator

Study Sites (1)

Faculty of Dental Medicine

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

RECRUITING

Central Study Contacts

Visnja Katic, Assistant Professor

CONTACT

38551345638; visnja.katic@uniri.hr

Doris Simac, PhD Student

CONTACT

+385 51 345638; doris.simac@uniri.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: April 8, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-07

Locations

CR (1)