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

Not Applicable

Completed

• Conditions: Rapid Maxillary Expansion; Sleep Apnea Syndrome
• Interventions: Procedure: Rapid Maxillary Expansion Treatment

• Registration Number: NCT04604392
• Lead Sponsor: Izmir Katip Celebi University

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 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.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-01-13
• Study Completion: 2017-05-17
• Status Verified: 2020-10
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-27
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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. AHI ≥ 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tooth-borne (Hyrax) expander	Rapid Maxillary Expansion Treatment	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.
Tooth tissue-borne (KBME) expander	Rapid Maxillary Expansion Treatment	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.
Bone-borne (MIDME) expander	Rapid Maxillary Expansion Treatment	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.

Primary Outcome Measures

Name	Time	Method
Correction of posterior crossbite	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 Outcome Measures

Name	Time	Method
Polygraphic assessment of sleep parameters	At baseline (T0) and after 3 months retention period (T1)	Changes in the value of Supin AHI