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3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders

ConditionRetrognathic Mandible
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorUniversity of Rijeka

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

retrognathic mandible, increased overjet

Disqualifiers

craniodentofacial deformities

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Functional appliance groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
from enrollment and predicted outcome to the end of treatment at one year on average
2

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.

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

Secondary outcomes

1

Latero-lateral cephalogram

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rijeka

Lead sponsor

Source ClinicalTrials.gov
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