3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders

NCT ID: NCT06726005

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2027-07-31

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.

Detailed Description

The harmonious growth of the upper and lower jaw enables further favorable development of the orofacial region and the functions of breathing, chewing, swallowing and speaking, as well as the general growth and development of the child. Translation into Croatian and administration of the questionnaire for early detection of sleep disorders related to breathing in children (PSQ) will enable triage and early recognition of children with sleep disorders, which also affect general psycho-physical development. The impact of functional appliance therapy (FA) on changes in craniodentofacial characteristics, dimensions of the upper airway and sleep problems in children will be determined. The non-invasive three-dimensional representation of the face surface provides information about the surface and volume of the observed object, which is used for better diagnostics and therapy planning. Class II is a frequent malocclusion, characterized by a discrepancy of sagittal interjaw relationships. The diagnostic method, which helps in deciding on a therapeutic approach, is the so-called Fränkel maneuver (FM). By comparing the observation of the soft tissue profile of the subjects at rest and after the application of FM, a decision is made on the therapeutic approach. Previous research indicates the validity of using FM in making a decision about FN therapy, with high reliability and consistency. The analysis of latero-lateral (LL) X-ray cephalograms in numerous studies has provided a series of data, which is used, among other things, to assess the remaining growth in order to apply FN therapy in a timely manner, but also to expect a desirable response. The evaluation of the success of therapy based on FM don't exist, because a reliable 2D analysis through LL cephalogram would require additional radiation of the subjects. Research indicates that the analysis of scan surfaces is more appropriate than the analysis of anatomical points for detection of the area and amount of changes.

Conditions

Retrognathic Mandible

Keywords

PSQ; Twin block; 3D facial scan

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Functional appliance group

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

Group Type: EXPERIMENTAL

functional appliance twin block

Intervention Type: 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.

Interventions

functional appliance twin block

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• retrognathic mandible, increased overjet

Exclusion Criteria

• craniodentofacial deformities

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rijeka

OTHER

Sponsor Role: lead

Responsible Party

Visnja Katic

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dental Medicine

Rijeka, Primorje-Gorski Kotar County, Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Visnja Katic, Assistant Professor

Role: CONTACT

Phone: 385 51 345638

Email: visnja.katic@uniri.hr

Facility Contacts

Department of Orthodontics

Role: primary

Other Identifiers

uniri-iskusni-biomed-23-36

Identifier Type: -

Identifier Source: org_study_id