Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality

Sleep Apnea Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529213
• Other study ID #: 0024
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: May 17, 2017

Study information

• Verified date: August 2020
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 17, 2017
• Est. primary completion date: January 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Palatal Expansion Technique
• Sleep Apnea Syndromes

Intervention

Procedure:
• Rapid Maxillary Expansion Treatment
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correction of posterior crossbite	The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.	After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.
Secondary	Polygraphic assessment of sleep parameters	Changes in apnea hypopnea index (AHI)	After 3 months treatment retention period
Secondary	Polygraphic assessment of sleep parameters	Changes in number of apnea and hypopnea	After 3 months treatment retention period
Secondary	Polygraphic assessment of sleep parameters	Changes in number of hypopnea	After 3 months treatment retention period
Secondary	Polygraphic assessment of sleep parameters	Changes in desaturation index	After 3 months treatment retention period
Secondary	Polygraphic assessment of sleep parameters	Changes in lowest desaturation	After 3 months treatment retention period
Secondary	Polygraphic assessment of sleep parameters	Changes in average saturation	After 3 months treatment retention period
Secondary	Polygraphic assessment of sleep parameters	Changes in the value of Supin AHI	After 3 months treatment retention period