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3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06726005
Acronym
FA PSQ HR
Enrollment
20
Registered
2024-12-10
Start date
2024-04-08
Completion date
2027-07-31
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retrognathic Mandible

Keywords

PSQ, Twin block, 3D facial scan

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.

Interventions

DEVICEfunctional 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.

Sponsors

University of Rijeka
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* retrognathic mandible, increased overjet

Exclusion criteria

* craniodentofacial deformities

Design outcomes

Primary

MeasureTime frameDescription
Facial scanfrom enrollment and predicted outcome to the end of treatment at one year on averageUsing 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.
PSQ questionnairefrom enrollment to the end of treatment at one year on averageParents / 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

MeasureTime frameDescription
Latero-lateral cephalogramfrom enrollment to the end of treatment at one year on averageCranio-dento-facial characteristics will be assessed prior to and at the end of treatment with functional appliance.

Countries

Croatia

Contacts

Primary ContactVisnja Katic, Assistant Professor
visnja.katic@uniri.hr385 51 345638

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026