Retrognathic MandibleFA PSQ HRNCT06726005
3D Characteristics, Functional Appliances and Sleep Related Breathing Disorders
A study testing functional appliance twin block in people with Retrognathic Mandible, run by University of Rijeka at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Retrognathic Mandible
- What is being tested?
- functional appliance twin block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCroatia
- Study dates
- 8 Apr 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- retrognathic mandible, increased overjet
Who cannot join
- craniodentofacial deformities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine
Rijeka, Primorje-Gorski Kotar County, 51000
Department of Orthodontics, 385 51 345638, visnja.katic@uniri.hr
About this study
Official title: Impact of Functional Appliances on 3D Craniodentofacial Characteristics and Reported Sleep Related Breathing Disorders in Children
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.
Read the 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
- Being tested
- functional appliance twin block
- Keywords
- PSQ, Twin block, 3D facial scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional appliance twin blockDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional appliance group | Experimental | Upon diagnostics, functional appliance Twin block will be proposed to the participants for one year. Receives: Device: functional appliance twin block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: from enrollment to the end of treatment at one year on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start8 Apr 2024
- Primary completionJun 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrognathic MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visnja Katic, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726005
- Sponsor's protocol ID
- uniri-iskusni-biomed-23-36
- Acronym
- FA PSQ HR
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data contain identifiable biometric data, and will be disclosed only upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Functional Appliances on 3D Craniodentofacial Characteristics and Reported Sleep Related Breathing Disorders in Children
- ClinicalTrials.gov ID
- NCT06726005
- Acronym / sponsor ID
- FA PSQ HR / uniri-iskusni-biomed-23-36
- Conditions
- Retrognathic Mandible
- Keywords
- PSQ, Twin block, 3D facial scan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional appliance group | Experimental | Device: functional appliance twin blockUpon diagnostics, functional appliance Twin block will be proposed to the participants for one year. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- retrognathic mandible, increased overjet
Key exclusion criteria (1 listed)
- craniodentofacial deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional appliance twin block3D 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. | Device | Functional appliance group |
Primary outcome
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.
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.
1 secondary outcome
Latero-lateral cephalogram
Time frame: from enrollment to the end of treatment at one year on average
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided. Data contain identifiable biometric data, and will be disclosed only upon reasonable request.
Related trials for Retrognathic Mandible
Enrolling by invitation
Three-Dimensional Evaluation of Pharyngeal Airway and Facial Dimension Changes in Skeletal Class II Patients Treated With Twin Block Versus Myobrace Appliances
Class II Division 1 Adolescent Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional appliance twin block in people with Retrognathic Mandible, run by University of Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Visnja Katic, Assistant Professor (385 51 345638, visnja.katic@uniri.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial scan (time frame: from enrollment and predicted outcome to the end of treatment at one year on average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.