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Completed

NCT Number: NCT04604392

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rapid Maxillary Expansion Treatment

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Polygraphic assessment of sleep parameters

    Time frame: At baseline (T0) and after 3 months retention period (T1)

    Changes in apnea hypopnea index (AHI)

  2. Polygraphic assessment of sleep parameters

    Time frame: At baseline (T0) and after 3 months retention period (T1)

    Changes in desaturation index

  3. Polygraphic assessment of sleep parameters

    Time frame: At baseline (T0) and after 3 months retention period (T1)

    Changes in lowest desaturation

  4. Polygraphic assessment of sleep parameters

    Time frame: At baseline (T0) and after 3 months retention period (T1)

    Changes in average saturation

  5. Polygraphic assessment of sleep parameters

    Time frame: At baseline (T0) and after 3 months retention period (T1)

    Changes in the value of Supin AHI

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Obstructive Sleep Apnea: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2020
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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