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

Primary Purpose

Sleep Apnea Syndrome, Rapid Maxillary Expansion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rapid Maxillary Expansion Treatment
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea, Rapid Maxillary Expansion, Polygraphy

Eligibility Criteria

12 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Tooth tissue-borne (KBME) expander

    Tooth-borne (Hyrax) expander

    Bone-borne (MIDME) expander

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Correction of posterior crossbite
    The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.

    Secondary Outcome Measures

    Polygraphic assessment of sleep parameters
    Changes in apnea hypopnea index (AHI)
    Polygraphic assessment of sleep parameters
    Changes in desaturation index
    Polygraphic assessment of sleep parameters
    Changes in lowest desaturation
    Polygraphic assessment of sleep parameters
    Changes in average saturation
    Polygraphic assessment of sleep parameters
    Changes in the value of Supin AHI

    Full Information

    First Posted
    October 21, 2020
    Last Updated
    October 21, 2020
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04604392
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    January 13, 2017 (Actual)
    Study Completion Date
    May 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea Syndrome, Rapid Maxillary Expansion
    Keywords
    Obstructive Sleep Apnea, Rapid Maxillary Expansion, Polygraphy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    3-arm parallel trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double (Participant, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tooth tissue-borne (KBME) expander
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Tooth-borne (Hyrax) expander
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Bone-borne (MIDME) expander
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Rapid Maxillary Expansion Treatment
    Intervention Description
    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 Outcome Measure Information:
    Title
    Correction of posterior crossbite
    Description
    The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
    Time Frame
    After active expansion (up to 3 weeks). The evaluation of the result has been made by the physician with intraoral clinical examination.
    Secondary Outcome Measure Information:
    Title
    Polygraphic assessment of sleep parameters
    Description
    Changes in apnea hypopnea index (AHI)
    Time Frame
    At baseline (T0) and after 3 months retention period (T1)
    Title
    Polygraphic assessment of sleep parameters
    Description
    Changes in desaturation index
    Time Frame
    At baseline (T0) and after 3 months retention period (T1)
    Title
    Polygraphic assessment of sleep parameters
    Description
    Changes in lowest desaturation
    Time Frame
    At baseline (T0) and after 3 months retention period (T1)
    Title
    Polygraphic assessment of sleep parameters
    Description
    Changes in average saturation
    Time Frame
    At baseline (T0) and after 3 months retention period (T1)
    Title
    Polygraphic assessment of sleep parameters
    Description
    Changes in the value of Supin AHI
    Time Frame
    At baseline (T0) and after 3 months retention period (T1)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gökçenur Gökçe, Phd
    Organizational Affiliation
    Izmir Katip Celebi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35789454
    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.
    Results Reference
    derived

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

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