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NCT Number: NCT06726005

3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders

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.

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Key information

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location status: Recruiting

Location contact

Department of Orthodontics

CONTACT

[email protected]

385 51 345638

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • retrognathic mandible, increased overjet

Exclusion criteria

  • craniodentofacial deformities

Treatment and study plan

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.

Primary outcomes

  1. Facial scan

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

    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.

  2. PSQ questionnaire

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

    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.

Secondary outcomes

  1. Latero-lateral cephalogram

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

    Cranio-dento-facial characteristics will be assessed prior to and at the end of treatment with functional appliance.

Study contacts

Contact information is provided by the study sponsor or research team.

Visnja Katic, Assistant Professor

CONTACT

[email protected]

385 51 345638

Sponsors and collaborators

Lead sponsor

University of Rijeka

Other

Registry information

Official study title

Impact of Functional Appliances on 3D Craniodentofacial Characteristics and Reported Sleep Related Breathing Disorders in Children

Acronym: FA PSQ HR

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

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.

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