Sleep Apnea SyndromesNCT04529213
Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality
A study testing Rapid Maxillary Expansion Treatment in people with Sleep Apnea Syndromes and Palatal Expansion Technique, run by Izmir Katip Celebi University.
Trial summary
Rapid maxillary expansion (RME) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.The aim of this randomized controlled trial was to evaluate the effects of… Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Sleep Apnea Syndromes, Palatal Expansion Technique
- What is being tested?
- Rapid Maxillary Expansion Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 17 May 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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
- Bilateral crossbite and need for RME,
- Maxillary and mandibular permanent teeth fully erupted,
- Willingness to participate in the study
Who cannot join
- the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
- having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
- history of previous orthodontic treatment.
About this study
Official title: Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality: A Randomized Clinical Trial
Rapid maxillary expansion (RME) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.The aim of this randomized controlled trial was to evaluate the effects of tooth-borne, tooth tissue-borne and bone-borne RME appliances on sleep quality with polygraphy. The null hypothesis was that there is no difference for the sleep quality between the appliances.
Read the detailed description
Introduction. The aim of this 3-arm randomized controlled trial (RCT) was to evaluate the effects of tooth tissue-borne (KBME), tooth-borne (Hyrax), and bone-borne (MIDME) rapid maxillary expansion (RME) appliances on sleep quality with polygraphy.
Methods. This study was designed in parallel with an allocation ratio of 1:1:1. 46 patients with narrow maxilla and OSAS were included in this study and randomly assigned to three groups: tooth tissue-borne, tooth-borne and bone-borne expanders. Participants were congregated from the Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Turkey. In all groups, the expansion appliance was activated one-quarter turn twice a day until the desired suture opening was achieved. The primary outcome of this study was the correction of posterior crossbite. Secondary outcomes included polygraphic assessment of sleep parameters. Each subject participated in 1 overnight sleep test with polygraphy before the expansion (T0) and after a 3-month retention phase of treatment (T1). According to the results of polygraphy, 7 parameters; (apnea hypopnea index (AHI), number of apnea and hypopnea, desaturation index, lowest desaturation, average saturation, supin AHI) were examined to evaluate the changes in sleep scores. Kruskal-Wallis analysis and Dunn-Bonferroni test were used for inter-group comparisons and Wilcoxon analysis was used for intra-group evalaution. P<0.05 was accepted statistically significant. Computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. The outcome assessor was blinded to group assignment. The outcome assessor was blinded; however, it was not feasible to blind either operator or patients.
- Conditions
- Sleep Apnea Syndromes, Palatal Expansion Technique
- Being tested
- Rapid Maxillary Expansion Treatment
- Keywords
- Polygraphy, Obstructive Sleep Apnea, Rapid Maxillary Expansion
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Maxillary Expansion TreatmentProcedure or surgery
The patients were treated with KBME, Hyrax and MIDME maxillary expansion appliances, respectively. All expansion appliances containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. In the MIDME group, two mini-screws with a diameter of 1.6 mm and a length of 10 mm are located on the right and left sides between the roots of the 2nd premolar and 1st molar teeth with 60-70° angle. KBME and Hyrax expansion appliances were cemented with glass ionomer cement and MIDME was cemented with using the light-cured composite. Same protocol was applied to all patients during RME treatment. Expansion screws in all groups were activated by two turns a day.
| Study group | Role | What they receive |
|---|---|---|
| Tooth tissue-borne (KBME) expander | Experimental | In this tooth tissue-borne appliance, the occlusal surfaces of the molar and premolar teeth and half of the palatinal and buccal surfaces are covered with heat polymerized acrylic. Hyrax expansion screw is in the midline, as far as possible to the palate positioned close and parallel Receives: Procedure: Rapid Maxillary Expansion Treatment |
| Tooth-borne (Hyrax) expander | Experimental | In this tooth-borne expansion appliance, orthodontic bands are placed on the right and left 1st premolar and 1st molar teeth of the patients and the bands are soldered to the Hyrax expansion screw. The expansion screw is in the midline, as far as possible to the palate positioned close and parallel Receives: Procedure: Rapid Maxillary Expansion Treatment |
| Bone-borne (MIDME) expander | Experimental | This bone-borne expander includes 2 mini-screws with a diameter of 1.6 mm and a length of 10 mm on the right and left sides, coinciding between the roots of the 2nd premolar and 1st molar teeth in addition to the hyrax expansion screw. Receives: Procedure: Rapid Maxillary Expansion Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of posterior crossbite
The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
Measured: After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.
Secondary outcomes (7)
Polygraphic assessment of sleep parameters
Changes in apnea hypopnea index (AHI)
Measured: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Changes in number of apnea and hypopnea
Measured: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Changes in number of hypopnea
Measured: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Changes in desaturation index
Measured: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Changes in lowest desaturation
Measured: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Changes in average saturation
Measured: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Changes in the value of Supin AHI
Measured: After 3 months treatment retention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Jul 2016
- Primary completion13 Jan 2017
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- 3-arm parallel trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçenur Gökçe, Izmir Katip Celebi University
- Investigators
- Gökçenur Gökçe, Phd, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529213
- Sponsor's protocol ID
- 0024
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 27 Aug 2020
- 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 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04529213
- Acronym / sponsor ID
- 0024
- Conditions
- Sleep Apnea Syndromes, Palatal Expansion Technique
- Keywords
- Polygraphy, Obstructive Sleep Apnea, Rapid Maxillary Expansion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 27 Aug 2020 (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.
Rapid maxillary expansion (RME) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.The aim of this randomized controlled trial was to evaluate the effects of tooth-borne, tooth tissue-borne and bone-borne RME appliances on sleep quality with polygraphy. The null hypothesis was that there is no difference for the sleep quality between the appliances.
Detailed description
Introduction. The aim of this 3-arm randomized controlled trial (RCT) was to evaluate the effects of tooth tissue-borne (KBME), tooth-borne (Hyrax), and bone-borne (MIDME) rapid maxillary expansion (RME) appliances on sleep quality with polygraphy.
Methods. This study was designed in parallel with an allocation ratio of 1:1:1. 46 patients with narrow maxilla and OSAS were included in this study and randomly assigned to three groups: tooth tissue-borne, tooth-borne and bone-borne expanders. Participants were congregated from the Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Turkey. In all groups, the expansion appliance was activated one-quarter turn twice a day until the desired suture opening was achieved. The primary outcome of this study was the correction of posterior crossbite. Secondary outcomes included polygraphic assessment of sleep parameters. Each subject participated in 1 overnight sleep test with polygraphy before the expansion (T0) and after a 3-month retention phase of treatment (T1). According to the results of polygraphy, 7 parameters; (apnea hypopnea index (AHI), number of apnea and hypopnea, desaturation index, lowest desaturation, average saturation, supin AHI) were examined to evaluate the changes in sleep scores. Kruskal-Wallis analysis and Dunn-Bonferroni test were used for inter-group comparisons and Wilcoxon analysis was used for intra-group evalaution. P<0.05 was accepted statistically significant. Computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. The outcome assessor was blinded to group assignment. The outcome assessor was blinded; however, it was not feasible to blind either operator or patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm parallel trial
| Arm | Type | Receives |
|---|---|---|
| Tooth tissue-borne (KBME) expander | Experimental | Procedure: Rapid Maxillary Expansion TreatmentIn this tooth tissue-borne appliance, the occlusal surfaces of the molar and premolar teeth and half of the palatinal and buccal surfaces are covered with heat polymerized acrylic. Hyrax expansion screw is in the midline, as far as possible to the palate positioned close and parallel |
| Tooth-borne (Hyrax) expander | Experimental | Procedure: Rapid Maxillary Expansion TreatmentIn this tooth-borne expansion appliance, orthodontic bands are placed on the right and left 1st premolar and 1st molar teeth of the patients and the bands are soldered to the Hyrax expansion screw. The expansion screw is in the midline, as far as possible to the palate positioned close and parallel |
| Bone-borne (MIDME) expander | Experimental | Procedure: Rapid Maxillary Expansion TreatmentThis bone-borne expander includes 2 mini-screws with a diameter of 1.6 mm and a length of 10 mm on the right and left sides, coinciding between the roots of the 2nd premolar and 1st molar teeth in addition to the hyrax expansion screw. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
- Bilateral crossbite and need for RME,
- Maxillary and mandibular permanent teeth fully erupted,
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
- having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor 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 |
|---|---|---|
| Rapid Maxillary Expansion TreatmentThe patients were treated with KBME, Hyrax and MIDME maxillary expansion appliances, respectively. All expansion appliances containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. In the MIDME group, two mini-screws with a diameter of 1.6 mm and a length of 10 mm are located on the right and left sides between the roots of the 2nd premolar and 1st molar teeth with 60-70° angle. KBME and Hyrax expansion appliances were cemented with glass ionomer cement and MIDME was cemented with using the light-cured composite. Same protocol was applied to all patients during RME treatment. Expansion screws in all groups were activated by two turns a day. | Procedure or surgery | Bone-borne (MIDME) expander, Tooth tissue-borne (KBME) expander, Tooth-borne (Hyrax) expander |
Primary outcome
Correction of posterior crossbite
Time frame: After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.
The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
7 secondary outcomes
Polygraphic assessment of sleep parameters
Time frame: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Time frame: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Time frame: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Time frame: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Time frame: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Time frame: After 3 months treatment retention period
Polygraphic assessment of sleep parameters
Time frame: After 3 months treatment retention period
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 27 Aug 2020.
- 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, Phd principal investigator
Izmir Katip Celebi University
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Maxillary Expansion Treatment in people with Sleep Apnea Syndromes and Palatal Expansion Technique, run by Izmir Katip Celebi University.
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 4 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 posterior crossbite (time frame: After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.). 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 27 Aug 2020.