Sleep Apnea Syndromes in ChildrenNCT06660771
Evaluation of Functional Orthodontic Treatment on Sleep Quality
A study testing Functional orthodontic treatment in people with Sleep Apnea Syndromes in Children and Functional Orthodontic Treatment, run by Gökçenur Gökçe Kara at 1 site in Turkey (Türkiye).
Trial summary
Functional appliances are used in the treatment of Class II anomalies caused by mandibular rethrognathia. Herbst which is a fixed and rigid functional appliance and TWB which is removable appliance can be successful in the treatment of mandibular retrognathia in a short period of six to eight months during the… Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Sleep Apnea Syndromes in Children, Functional Orthodontic Treatment, Mandibular Retrognathia
- What is being tested?
- Functional orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2021to 28 May 2024
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- no prior orthodontic treatment, nasal, tonsillar, or adenoid surgery
- absence of any oral, nasal or systemic disease
- the existence of skeletal Class II and dental Class II Division 1 malocclusion (ANB >4°; SNB <80°; incisor overjet >3 mm)
- requiring functional orthodontic treatment
- Individuals are in the MP3cap and S period according to hand-wrist films, and in the CS3 and CS4 period using the CVM method
- patients with OSA (apnea/hypopnea index (AHI)>1/h
Who cannot join
- body mass index (BMI) ≥ 30 (weight (kg)/height (m2))
- the presence of nasopharyngeal pathologies, craniofacial anomalies, , systemic disorder, or weak oral hygiene
- history of previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polygraphic Evaluation of the Effects of Functional Orthodontic Treatment with Twin Block and Herbst Appliances on Sleep Quality: a Randomized Clinical Trial
Functional appliances are used in the treatment of Class II anomalies caused by mandibular rethrognathia. Herbst which is a fixed and rigid functional appliance and TWB which is removable appliance can be successful in the treatment of mandibular retrognathia in a short period of six to eight months during the pubertal growth phase. An increase in the upper airway size occurs as a result of functional orthopedic treatment devices eliminating the problem of mandibular retrognathia and stimulating mandibular growth. The aim of this randomized controlled trial was to evaluate the effects of TWB and Herbst appliances on sleep quality in children with obstructive sleep apnea. The null hypothesis was that there is no difference for the sleep quality between the appliances.
Read the detailed description
Introduction: This multicenter clinical study aimed to investigate the effects of twin block (TB) and Herbst functional appliances on sleep quality in children with OSAS and mandibular retrognathia. Methods: A total of 46 patients having mandibular retrognathia and identified with OSA were divided randomly into two groups: twin block (TB) and Herbst functional appliances. Changes in sleep parameters at baseline and an avarage of 8-month follow-up detected by polygraphy and Pittsburg Sleep Quality Index (PSQI) were the primary outcome. Treatment of the mandibular retrognathia was the secondary outcome. hapiro Wilk test and Q-Q graphs were used to examine the distribution assumptions of continuous variables according to groups. Mann Whitney U test was used to evaluate two independent group means or distributions of continuous measurements. Paired sample t test or Wilcoxon signed rank test was used to evaluate the differences between the baseline and follow-up times at p < 0.05 significance level.
- Conditions
- Sleep Apnea Syndromes in Children, Functional Orthodontic Treatment, Mandibular Retrognathia, Upper Airway
- Being tested
- Functional orthodontic treatment
- Keywords
- Obstructive sleep apnea, Herbst, Twin Block
- Medical subject headings
- Micrognathism, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional orthodontic treatmentProcedure or surgery
The patients were treated with Twin block and Herbst functional appliances. Alginate impressions and a protrusive wax bite were taken for the construction of each appliance. Each device was fitted and then reviewed 4-6 weeks later. First group was treated with Twin block which was manufactured basically according to the original design described by Clark. The overjet was measured from the patients in centric relationship and maximum protrusion position, and construction bite was recorded with 70% of the total advancement capacity of the mandible and 2-4 mm above the freeway space vertically. Overjet measurements were made at each session and active treatment was terminated when a normal overjet in the retracted position was recorded.
Second group was treated with the stainless-steel crown Herbst appliance, included crowned maxillary first molars and mandibular first premolars. The construction bite was recorded with the mandible forward by edge-to-edge incisor position.
| Study group | Role | What they receive |
|---|---|---|
| Herbst | Experimental | The Herbst appliance is fixed and rigid functional appliance. It consists of attachments (casted splints) in the lateral segments of both jaws which are connected by a telescoping mechanism from the upper posterior to the lower anterior region resulting in mandibular bite jumping. Receives: Procedure: Functional orthodontic treatment |
| Twin Block | Experimental | Twin-block appliance is used with two separate acrylic plates for the lower and upper jaw.
It consists of acrylic bite blocks that lock together at a 70° angle, allowing the mandible to be positioned in front. Receives: Procedure: Functional orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of mandibular retrognathia
A normal or corrected overjet in the retracted position
Measured: Following 6-8 months active treatment
Secondary outcomes (7)
Polygraphic assessment of sleep parameters
Changes in apnea hypopnea index (AHI)
Measured: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in number of apnea and hypopnea
Measured: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in number of hypopnea
Measured: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in desaturation index
Measured: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in lowest desaturation
Measured: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in average saturation
Measured: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in the value of Supin AHI
Measured: Following 6-8 months active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start5 May 2021
- Primary completion28 Jan 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndromes in ChildrenStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm parallel trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gökçenur Gökçe Kara
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Katip Celebi University, Ege University
- Responsible party
- Sponsor-investigator, Gökçenur Gökçe Kara, Marmara University
- Investigators
- Gökçenur Gökçe Kara, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660771
- Sponsor's protocol ID
- M01
- Status last verified
- Jul 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polygraphic Evaluation of the Effects of Functional Orthodontic Treatment with Twin Block and Herbst Appliances on Sleep Quality: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06660771
- Acronym / sponsor ID
- M01
- Conditions
- Sleep Apnea Syndromes in Children, Functional Orthodontic Treatment, Mandibular Retrognathia, Upper Airway
- Keywords
- Obstructive sleep apnea, Herbst, Twin Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Gökçenur Gökçe KaraUniversity, hospital or other
- Collaborators
- Izmir Katip Celebi University, Ege University
- Study start
- 5 May 2021 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 28 Oct 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.
Functional appliances are used in the treatment of Class II anomalies caused by mandibular rethrognathia. Herbst which is a fixed and rigid functional appliance and TWB which is removable appliance can be successful in the treatment of mandibular retrognathia in a short period of six to eight months during the pubertal growth phase. An increase in the upper airway size occurs as a result of functional orthopedic treatment devices eliminating the problem of mandibular retrognathia and stimulating mandibular growth. The aim of this randomized controlled trial was to evaluate the effects of TWB and Herbst appliances on sleep quality in children with obstructive sleep apnea. The null hypothesis was that there is no difference for the sleep quality between the appliances.
Detailed description
Introduction: This multicenter clinical study aimed to investigate the effects of twin block (TB) and Herbst functional appliances on sleep quality in children with OSAS and mandibular retrognathia. Methods: A total of 46 patients having mandibular retrognathia and identified with OSA were divided randomly into two groups: twin block (TB) and Herbst functional appliances. Changes in sleep parameters at baseline and an avarage of 8-month follow-up detected by polygraphy and Pittsburg Sleep Quality Index (PSQI) were the primary outcome. Treatment of the mandibular retrognathia was the secondary outcome. hapiro Wilk test and Q-Q graphs were used to examine the distribution assumptions of continuous variables according to groups. Mann Whitney U test was used to evaluate two independent group means or distributions of continuous measurements. Paired sample t test or Wilcoxon signed rank test was used to evaluate the differences between the baseline and follow-up times at p < 0.05 significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm parallel trial
| Arm | Type | Receives |
|---|---|---|
| Herbst | Experimental | Procedure: Functional orthodontic treatmentThe Herbst appliance is fixed and rigid functional appliance. It consists of attachments (casted splints) in the lateral segments of both jaws which are connected by a telescoping mechanism from the upper posterior to the lower anterior region resulting in mandibular bite jumping. |
| Twin Block | Experimental | Procedure: Functional orthodontic treatmentTwin-block appliance is used with two separate acrylic plates for the lower and upper jaw. It consists of acrylic bite blocks that lock together at a 70° angle, allowing the mandible to be positioned in front. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- no prior orthodontic treatment, nasal, tonsillar, or adenoid surgery
- absence of any oral, nasal or systemic disease
- the existence of skeletal Class II and dental Class II Division 1 malocclusion (ANB >4°; SNB <80°; incisor overjet >3 mm)
- requiring functional orthodontic treatment
- Individuals are in the MP3cap and S period according to hand-wrist films, and in the CS3 and CS4 period using the CVM method
Key exclusion criteria (3 listed)
- body mass index (BMI) ≥ 30 (weight (kg)/height (m2))
- the presence of nasopharyngeal pathologies, craniofacial anomalies, , systemic disorder, or weak oral hygiene
- history of previous orthodontic treatment
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 orthodontic treatmentThe patients were treated with Twin block and Herbst functional appliances. Alginate impressions and a protrusive wax bite were taken for the construction of each appliance. Each device was fitted and then reviewed 4-6 weeks later. First group was treated with Twin block which was manufactured basically according to the original design described by Clark. The overjet was measured from the patients in centric relationship and maximum protrusion position, and construction bite was recorded with 70% of the total advancement capacity of the mandible and 2-4 mm above the freeway space vertically. Overjet measurements were made at each session and active treatment was terminated when a normal overjet in the retracted position was recorded. Second group was treated with the stainless-steel crown Herbst appliance, included crowned maxillary first molars and mandibular first premolars. The construction bite was recorded with the mandible forward by edge-to-edge incisor position. | Procedure or surgery | Herbst, Twin Block |
Primary outcome
Correction of mandibular retrognathia
Time frame: Following 6-8 months active treatment
A normal or corrected overjet in the retracted position
7 secondary outcomes
Polygraphic assessment of sleep parameters
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Time frame: Following 6-8 months active treatment
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 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Gökçenur Gökçe Kara principal investigator
Marmara University
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 orthodontic treatment in people with Sleep Apnea Syndromes in Children and Functional Orthodontic Treatment, run by Gökçenur Gökçe Kara at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 28 Oct 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 Turkey (Türkiye). 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?
Correction of mandibular retrognathia (time frame: Following 6-8 months active treatment). 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 28 Oct 2024.