- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529213
Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality
Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tooth tissue-borne (KBME) expander
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
|
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.
|
Experimental: Tooth-borne (Hyrax) expander
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
|
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.
|
Experimental: Bone-borne (MIDME) expander
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polygraphic assessment of sleep parameters
Time Frame: After 3 months treatment retention period
|
Changes in apnea hypopnea index (AHI)
|
After 3 months treatment retention period
|
Polygraphic assessment of sleep parameters
Time Frame: After 3 months treatment retention period
|
Changes in number of apnea and hypopnea
|
After 3 months treatment retention period
|
Polygraphic assessment of sleep parameters
Time Frame: After 3 months treatment retention period
|
Changes in number of hypopnea
|
After 3 months treatment retention period
|
Polygraphic assessment of sleep parameters
Time Frame: After 3 months treatment retention period
|
Changes in desaturation index
|
After 3 months treatment retention period
|
Polygraphic assessment of sleep parameters
Time Frame: After 3 months treatment retention period
|
Changes in lowest desaturation
|
After 3 months treatment retention period
|
Polygraphic assessment of sleep parameters
Time Frame: After 3 months treatment retention period
|
Changes in average saturation
|
After 3 months treatment retention period
|
Polygraphic assessment of sleep parameters
Time Frame: After 3 months treatment retention period
|
Changes in the value of Supin AHI
|
After 3 months treatment retention period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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