Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Obstructive Sleep Apnea

I

Izmir Katip Celebi University

Status

Completed

Conditions

Sleep Apnea Syndrome
Rapid Maxillary Expansion

Treatments

Procedure: Rapid Maxillary Expansion Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04604392
024

Details and patient eligibility

About

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.

Full 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 boneborne 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.

Enrollment

46 patients

Sex

All

Ages

12 to 14 years old

Volunteers

No Healthy Volunteers

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,
  • AHI ≥ 1

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 3 patient groups

Tooth tissue-borne (KBME) expander
Experimental group
Description:
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.
Treatment:
Procedure: Rapid Maxillary Expansion Treatment
Tooth-borne (Hyrax) expander
Experimental group
Description:
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.
Treatment:
Procedure: Rapid Maxillary Expansion Treatment
Bone-borne (MIDME) expander
Experimental group
Description:
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.
Treatment:
Procedure: Rapid Maxillary Expansion Treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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