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

NCT04529213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-08-27

No results posted yet for this study

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.

Conditions

  • Sleep Apnea Syndromes
  • Palatal Expansion Technique

Interventions

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.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Principal Investigators

  • Gökçenur Gökçe, Phd · Izmir Katip Celebi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-01-13
Completion
2017-05-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529213 on ClinicalTrials.gov