3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders

NCT06726005 | Recruiting

• 1 other identifier: uniri-iskusni-biomed-23-36
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Facial scans of the patients eligible for the functional appliance treatment (Twin Block appliance) will be taken prior to and after the end of treatment. Also, a facial scan of the predicted final outcome will be taken, and compared to the actual final outcome. Parents / caregivers will fill out the Pediatric Sleep Questionnaire (PSQ) prior to and upon the end of treatment to asses perceived influence on sleep related breathing problems in their children.

Conditions

Retrognathic Mandible

Keywords

PSQ; Twin block; 3D facial scan

Outcome Measures

Primary Outcomes (2)

• Facial scan

  Using stereophotographic camera, 3D facial scans will be taken, and superimposed to observe differences prior to and at the end of treatment. Also, predicted outcome (facial scan taken in Fraenkel manouver position (at start)) will be compared to the actual outcome after one year of treatment with functional appliance Twin Block.

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

• PSQ questionnaire

  Parents / caregivers will fill out the PSQ questionnaire to assess influence of the functional appliance treatment on the sleep related breathing problems in their children.

  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 (1)

Functional appliance group

EXPERIMENTAL

Upon diagnostics, functional appliance Twin block will be proposed to the participants for one year.

Device: functional appliance twin block

Interventions

functional appliance twin block DEVICE

3D facial scans will be taken (prior to the treatment, at rest and at mandible moved forward to class I dental relation (Fraenkel manouver)) and at the end of treatment, one year later.

Functional appliance group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• retrognathic mandible, increased overjet

You may not qualify if:

• craniodentofacial deformities

Sponsors & Collaborators

• University of Rijeka: lead

Study Sites (1)

Faculty of Dental Medicine

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

RECRUITING

Central Study Contacts

Visnja Katic, Assistant Professor

CONTACT

385 51 345638; visnja.katic@uniri.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

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

Record last verified: 2024-04

Locations

CR (1)