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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04529213
Enrollment
46
Registered
2020-08-27
Start date
2016-07-01
Completion date
2017-05-17
Last updated
2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palatal Expansion Technique, Sleep Apnea Syndromes

Keywords

Polygraphy, Obstructive Sleep Apnea, Rapid Maxillary Expansion

Brief 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 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.

Interventions

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.

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

3-arm parallel trial

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

1. No previous tonsillar, nasal or adenoid surgery and orthodontic treatment, 2. Bilateral crossbite and need for RME, 3. Maxillary and mandibular permanent teeth fully erupted, 4. Willingness to participate in the study

Exclusion criteria

1. the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy 2. having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene, 3. history of previous orthodontic treatment.

Design outcomes

Primary

MeasureTime frameDescription
Correction of posterior crossbiteAfter 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.

Secondary

MeasureTime frameDescription
Polygraphic assessment of sleep parametersAfter 3 months treatment retention periodChanges in apnea hypopnea index (AHI)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026