Clinical trial NCT04604392: Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Obstructive Sleep Apnea
Official title: Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Obstructive Sleep Apnea: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Rapid Maxillary Expansion
Keywords: Obstructive Sleep Apnea
Rapid Maxillary Expansion
Polygraphy
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm parallel trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correction of posterior crossbite
timeFrame: After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.
Secondary outcomes:
measure: Polygraphic assessment of sleep parameters
timeFrame: At baseline (T0) and after 3 months retention period (T1)
measure: Polygraphic assessment of sleep parameters
timeFrame: At baseline (T0) and after 3 months retention period (T1)
measure: Polygraphic assessment of sleep parameters
timeFrame: At baseline (T0) and after 3 months retention period (T1)
measure: Polygraphic assessment of sleep parameters
timeFrame: At baseline (T0) and after 3 months retention period (T1)
measure: Polygraphic assessment of sleep parameters
timeFrame: At baseline (T0) and after 3 months retention period (T1)
Other outcomes:
Locations:
Study officials:
affiliation: Izmir Katip Celebi University
name: Gökçenur Gökçe, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gokce G, Basoglu OK, Veli I. Polygraphic evaluation of the effects of different rapid maxillary expansion appliances on sleep quality: A randomized clinical trial. Sleep Breath. 2023 May;27(2):651-659. doi: 10.1007/s11325-022-02677-0. Epub 2022 Jul 5.