Angle Class IINCT02448017
Effects of Herbst Appliance Therapy to Improve Airway Dimension
A study testing The Herbst appliance and Twin block appliance in people with Angle Class II, run by The University of Hong Kong at 1 site in China.
Trial summary
Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic patients with small lower jaws. Since small lower jaws are reported to be one of the main reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used to treat SDB children. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Angle Class II
- What is being tested?
- The Herbst appliance and Twin block appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Class II malocclusion
Who cannot join
- Cleft lip and palate
- Craniofacial syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
Faculty of Dentistry, the University of Hong Kong
Hong Kong, Hong Kong, 00852
About this study
Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic patients with small lower jaws. Since small lower jaws are reported to be one of the main reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used to treat SDB children. Previously no study compared the effects of Herbst appliance therapy with removable functional appliance on airway dimension, so it still remains unclear which kinds of functional appliance is more suitable for improving airway dimension. This study will assess the effect of Herbst appliance on airway dimension and compare the effects with those of twin block appliance (a popular 24 hours used removable functional appliance, and also commonly used to treat adult sleep apnea).
Read the detailed description
Sleep disordered breathing (SDB) is an important paediatric problem. It is estimated that 3.2% to 12.1% of children have habitual snoring and 0.7% to 10.3% have obstructive sleep apnea syndrome (OSAS). Children OSAS is associated with a series of daytime and nighttime signs and symptoms. Nighttime symptoms include heavy snoring, restless sleep, heavy seating and enuresis, etc. Daytime symptoms include excessive daytime sleepiness and abnormal behavior such as aggressiveness and hyperactivity, etc. Untreated OSAS was reported to result in serious morbidity, such as failure to thrive, poor learning, attention deficit and hyperactivity disorder, etc.
There is an increasing concern related to sleep disordered breathing(SDB) of children by orthodontists. Since not only the tonsilar and adenoid hypertrophy is the main cause of paediatric OSA, but also craniofacial anomalies such as retrognathic mandible, narrow maxillary palatal arch and increased lower facial height can also contribute to it, orthopedic treatment such as rapid maxillary expansion (RME) and mandibular advancement device (MAD) may potentially permanently cure the children OSA. RME which is used to widen maxilla, thus increasing the nasal cavity and improving the nasal flow, has been thoroughly researched. However, only a few previous studies focused on the treatment effect of MAD for treating OSA children. These studies showed sorts of MAD such as jaw-positioning appliance, mono-block, and Herbst appliance were effective to OSA children, but it remains unclear how to choose a functional appliance, and if there is any treatment difference between removable functional appliance and fixed functional appliance for improving airway dimension.
- Conditions
- Angle Class II
- Being tested
- The Herbst appliance, Twin block appliance
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Herbst applianceDevice
Orthodontic functional appliance
Twin block applianceDevice
Orthodontic functional appliance
| Study group | Role | What they receive |
|---|---|---|
| The Herbst appliance | Active comparator | Orthodontic functional appliance Receives: Device: The Herbst appliance |
| Twin block appliance | Active comparator | Orthodontic functional appliance Receives: Device: Twin block appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cephalometric measurement of dimensional change of upper way following 2-phase orthodontic treatment
The two-phase treatment effects of Herbst and twin-block appliances on the upper airway are to be compared based on the lateral cephalometric analysis at three time points (T0: pre-treatment; T1: following 1 year functional appliance treatment; T3: following 2 years fixed appliance treatment). The parameters of lateral cephalometric analysis include the measurements of the depth of pharynx, the size of soft palate and the position of the hyoid bone.
Measured: 3 years two-phase treatment with functional appliance and fixed appliance
Secondary outcomes (1)
The three-dimensional change of upper way following 2-phase orthodontic treatment in magnetic resonance images
The two-phase treatment effects of Herbst and twin-block appliances on the upper airway are to be compared based on the analyses of magnetic resonance images at three time points (T0: pre-treatment; T1: following 1 year functional appliance treatment; T3: following 2 years fixed appliance treatment).The analyses include measurements of the depth and width of pharynx, the size of soft palate and the tongue.
Measured: 3 years two-phase treatment with functional appliance and fixed appliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJul 2012
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class IIStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanqi Yang, Principal investigator, The Paediatric dentistry and orthodontic department, Faculty of Dentistry, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448017
- Sponsor's protocol ID
- HKCTR-1858
- Status last verified
- May 2018
- First submitted
- 4 Feb 2015
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Herbst Appliance Therapy to Improve Airway Dimension
- ClinicalTrials.gov ID
- NCT02448017
- Acronym / sponsor ID
- HKCTR-1858
- Conditions
- Angle Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 May 2015 (estimated)
- 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.
Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic patients with small lower jaws. Since small lower jaws are reported to be one of the main reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used to treat SDB children. Previously no study compared the effects of Herbst appliance therapy with removable functional appliance on airway dimension, so it still remains unclear which kinds of functional appliance is more suitable for improving airway dimension. This study will assess the effect of Herbst appliance on airway dimension and compare the effects with those of twin block appliance (a popular 24 hours used removable functional appliance, and also commonly used to treat adult sleep apnea).
Detailed description
Sleep disordered breathing (SDB) is an important paediatric problem. It is estimated that 3.2% to 12.1% of children have habitual snoring and 0.7% to 10.3% have obstructive sleep apnea syndrome (OSAS). Children OSAS is associated with a series of daytime and nighttime signs and symptoms. Nighttime symptoms include heavy snoring, restless sleep, heavy seating and enuresis, etc. Daytime symptoms include excessive daytime sleepiness and abnormal behavior such as aggressiveness and hyperactivity, etc. Untreated OSAS was reported to result in serious morbidity, such as failure to thrive, poor learning, attention deficit and hyperactivity disorder, etc.
There is an increasing concern related to sleep disordered breathing(SDB) of children by orthodontists. Since not only the tonsilar and adenoid hypertrophy is the main cause of paediatric OSA, but also craniofacial anomalies such as retrognathic mandible, narrow maxillary palatal arch and increased lower facial height can also contribute to it, orthopedic treatment such as rapid maxillary expansion (RME) and mandibular advancement device (MAD) may potentially permanently cure the children OSA. RME which is used to widen maxilla, thus increasing the nasal cavity and improving the nasal flow, has been thoroughly researched. However, only a few previous studies focused on the treatment effect of MAD for treating OSA children. These studies showed sorts of MAD such as jaw-positioning appliance, mono-block, and Herbst appliance were effective to OSA children, but it remains unclear how to choose a functional appliance, and if there is any treatment difference between removable functional appliance and fixed functional appliance for improving airway dimension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Herbst appliance | Active comparator | Device: The Herbst applianceOrthodontic functional appliance |
| Twin block appliance | Active comparator | Device: Twin block applianceOrthodontic functional appliance |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Class II malocclusion
Key exclusion criteria (2 listed)
- Cleft lip and palate
- Craniofacial syndrome
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 |
|---|---|---|
| The Herbst applianceOrthodontic functional appliance | Device | The Herbst appliance |
| Twin block applianceOrthodontic functional appliance | Device | Twin block appliance |
Primary outcome
The cephalometric measurement of dimensional change of upper way following 2-phase orthodontic treatment
Time frame: 3 years two-phase treatment with functional appliance and fixed appliance
The two-phase treatment effects of Herbst and twin-block appliances on the upper airway are to be compared based on the lateral cephalometric analysis at three time points (T0: pre-treatment; T1: following 1 year functional appliance treatment; T3: following 2 years fixed appliance treatment). The parameters of lateral cephalometric analysis include the measurements of the depth of pharynx, the size of soft palate and the position of the hyoid bone.
1 secondary outcome
The three-dimensional change of upper way following 2-phase orthodontic treatment in magnetic resonance images
Time frame: 3 years two-phase treatment with functional appliance and fixed appliance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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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. This study is not recruiting at the moment.
Yanqi Yang principal investigator
The Paediatric dentistry and orthodontic department, Faculty of Dentistry, the University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Herbst appliance and Twin block appliance in people with Angle Class II, run by The University of Hong Kong at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 4 May 2018. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cephalometric measurement of dimensional change of upper way following 2-phase orthodontic treatment (time frame: 3 years two-phase treatment with functional appliance and fixed appliance). 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 4 May 2018.