Narrow MaxillaRPE PSQ HRNCT06725979
Effect of the Palatal Expansion Treatment on Reported Sleeping Disorders in Children
A study testing maxillary expansion using hyrax expander in people with Narrow Maxilla, run by University of Rijeka at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to see if expanding the upper jaw with orthodontic therapy can help improve sleep related breathing problems in children. Parents or caregivers will complete the Pediatric Sleep Questionnaire (PSQ) to assess their child's sleep before and after treatment. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Narrow Maxilla
- What is being tested?
- maxillary expansion using hyrax expander
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- narrow maxilla
Who cannot join
- hypodontia, craniodentofacial deformity-
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: Effect of the Rapid Palatal Expansion Treatment on Reported Sleeping Disorders in Children
The goal of this clinical trial is to see if expanding the upper jaw with orthodontic therapy can help improve sleep related breathing problems in children. Parents or caregivers will complete the Pediatric Sleep Questionnaire (PSQ) to assess their child's sleep before and after treatment.
The study will include 20 children with a narrow upper jaw, and a control group of children without this condition. The main questions it aims to answer are:
Read more
- Will the 3D scans show significant changes in the face after therapy?
- Will the dental scans show a larger palate volume after treatment?
- Will parents/caregivers notice an improvement in their children's sleep problems after therapy? Researchers will compare 3D facial and dental scans, as well as PSQ results, before and one year after therapy to see if the treatment makes a difference.
Participants will:
- Receive orthodontic treatment to expand the upper jaw.
- Have their sleep related breathing problems assessed by parents or caregivers using the PSQ before and after treatment.
- Have 3D scans of their face and teeth taken before and after treatment.
Read the detailed description
This comprehensive clinical study focuses on evaluating the therapeutic impact of orthodontic maxillary expansion treatment on sleep disorder assessments in children, as reported by their parents or guardians using the Pediatric Sleep Questionnaire (PSQ). Maxillary transverse constriction is a developmental disorder that can adversely affect the orofacial region, potentially influencing breathing patterns during sleep. The primary objective is to investigate whether orthodontic intervention to widen the upper jaw can lead to favorable developmental outcomes in the orofacial region and potentially alleviate sleep-related breathing disorders.
The study will involve 20 patients diagnosed with transverse maxillary constriction, identified through 3D scans of their face and dentition, compared against a control group of individuals without such constriction. Before and one year after treatment, participants will undergo 3D scanning of their facial structure and dentition, complemented by the completion of PSQ questionnaires by their parents or guardians. The study\'s hypotheses propose that following treatment, there will be notable changes in the mid-facial region evident from 3D facial scans, an increase in palate volume as indicated by dental scans, and a moderate improvement in reported sleep disorder symptoms based on parental observations.
The research methodology incorporates non-invasive 3D facial scanning technology, a methodological advancement that allows for precise assessment of facial changes pre-treatment and post-treatment. This approach contrasts with traditional 2D imaging, offering more detailed and accurate data on structural alterations. The study also highlights the utility of PSQ as a validated tool for evaluating sleep disorders in children, avoiding the need for expensive polysomnography.
By utilizing advanced imaging techniques and validated questionnaires, researchers seek to objectively measure treatment outcomes and correlate them with improvements in sleep quality and respiratory function. The study will utilize specialized equipment such as the Bellus 3D facial scanner and the Audaxceph software.
Ultimately, this study aims to enhance our understanding of the relationship between maxillary expansion therapy and sleep disorder improvement in children, potentially paving the way for optimized treatment protocols and improved patient outcomes sleep related breathing problems.
- Conditions
- Narrow Maxilla
- Being tested
- maxillary expansion using hyrax expander
- Keywords
- palatal expansion, PSQ, facial scan, orthodontics, hyrax expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary expansion using hyrax expanderDevice
Also called rapid palatal expansion
The rapid expansion of the upper jaw will be performed using palatal expander with hyrax screw, which will be activated 2x a day, until the needed width is reached (according to the cast analysis).
| Study group | Role | What they receive |
|---|---|---|
| Rapid maxillary expansion group | Active comparator | expansion of the maxilla with hyrax expander Receives: Device: maxillary expansion using hyrax expander |
| control | No intervention | no need for the maxillary expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial scan
3D facial scan of the surface of the face using stereo-photography
Measured: from enrollment to the end of treatment at one year on average
Dental scan
3D scan of dentition
Measured: from enrollment to the end of treatment at one year on average
PSQ questionnaire
Pediatric Sleep Questionnaire (PSQ) filled by the parents / caregivers
Measured: from enrollment to the end of treatment at one year on average
Secondary outcomes (1)
Latero-lateral cephalogram
Cranio-dento-facial characteristics as measured on latero-lateral cephalogram
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 completionOct 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 Narrow MaxillaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- 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
- NCT06725979
- Sponsor's protocol ID
- RPE PSQ
- Other IDs
- uniri-iskusni-biomed-23-36
- Acronym
- RPE PSQ HR
- Status last verified
- Jul 2024
- First submitted
- 5 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD contains identifiable biometric data, and will be disclosed only on 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
- Effect of the Rapid Palatal Expansion Treatment on Reported Sleeping Disorders in Children
- ClinicalTrials.gov ID
- NCT06725979
- Acronym / sponsor ID
- RPE PSQ HR / RPE PSQ
- Conditions
- Narrow Maxilla
- Keywords
- palatal expansion, PSQ, facial scan, orthodontics, hyrax expander
- 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
- Oct 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.
The goal of this clinical trial is to see if expanding the upper jaw with orthodontic therapy can help improve sleep related breathing problems in children. Parents or caregivers will complete the Pediatric Sleep Questionnaire (PSQ) to assess their child's sleep before and after treatment.
The study will include 20 children with a narrow upper jaw, and a control group of children without this condition. The main questions it aims to answer are:
- Will the 3D scans show significant changes in the face after therapy?
- Will the dental scans show a larger palate volume after treatment?
- Will parents/caregivers notice an improvement in their children's sleep problems after therapy? Researchers will compare 3D facial and dental scans, as well as PSQ results, before and one year after therapy to see if the treatment makes a difference.
Participants will:
- Receive orthodontic treatment to expand the upper jaw.
- Have their sleep related breathing problems assessed by parents or caregivers using the PSQ before and after treatment.
- Have 3D scans of their face and teeth taken before and after treatment.
Detailed description
This comprehensive clinical study focuses on evaluating the therapeutic impact of orthodontic maxillary expansion treatment on sleep disorder assessments in children, as reported by their parents or guardians using the Pediatric Sleep Questionnaire (PSQ). Maxillary transverse constriction is a developmental disorder that can adversely affect the orofacial region, potentially influencing breathing patterns during sleep. The primary objective is to investigate whether orthodontic intervention to widen the upper jaw can lead to favorable developmental outcomes in the orofacial region and potentially alleviate sleep-related breathing disorders.
The study will involve 20 patients diagnosed with transverse maxillary constriction, identified through 3D scans of their face and dentition, compared against a control group of individuals without such constriction. Before and one year after treatment, participants will undergo 3D scanning of their facial structure and dentition, complemented by the completion of PSQ questionnaires by their parents or guardians. The study\'s hypotheses propose that following treatment, there will be notable changes in the mid-facial region evident from 3D facial scans, an increase in palate volume as indicated by dental scans, and a moderate improvement in reported sleep disorder symptoms based on parental observations.
The research methodology incorporates non-invasive 3D facial scanning technology, a methodological advancement that allows for precise assessment of facial changes pre-treatment and post-treatment. This approach contrasts with traditional 2D imaging, offering more detailed and accurate data on structural alterations. The study also highlights the utility of PSQ as a validated tool for evaluating sleep disorders in children, avoiding the need for expensive polysomnography.
By utilizing advanced imaging techniques and validated questionnaires, researchers seek to objectively measure treatment outcomes and correlate them with improvements in sleep quality and respiratory function. The study will utilize specialized equipment such as the Bellus 3D facial scanner and the Audaxceph software.
Ultimately, this study aims to enhance our understanding of the relationship between maxillary expansion therapy and sleep disorder improvement in children, potentially paving the way for optimized treatment protocols and improved patient outcomes sleep related breathing problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid maxillary expansion group | Active comparator | Device: maxillary expansion using hyrax expanderexpansion of the maxilla with hyrax expander |
| control | No intervention | –no need for the maxillary expansion |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- narrow maxilla
Key exclusion criteria (1 listed)
- hypodontia, craniodentofacial deformity-
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 |
|---|---|---|
| maxillary expansion using hyrax expanderAlso: rapid palatal expansionThe rapid expansion of the upper jaw will be performed using palatal expander with hyrax screw, which will be activated 2x a day, until the needed width is reached (according to the cast analysis). | Device | Rapid maxillary expansion group |
Primary outcome
Facial scan
Time frame: from enrollment to the end of treatment at one year on average
3D facial scan of the surface of the face using stereo-photography
Dental scan
Time frame: from enrollment to the end of treatment at one year on average
3D scan of dentition
PSQ questionnaire
Time frame: from enrollment to the end of treatment at one year on average
Pediatric Sleep Questionnaire (PSQ) filled by the parents / caregivers
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. IPD contains identifiable biometric data, and will be disclosed only on reasonable request.
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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 maxillary expansion using hyrax expander in people with Narrow Maxilla, 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 (38551345638, 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 to the end of treatment at one year on average). The study lists 3 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.