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Evaluation of the Effect of Different Rapid Maxillary Expansion Appliances on Airway by Acoustic Rhinometry

Primary Purpose

Posterior Crossbite, Upper Airway

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 Posterior Crossbite, Upper Airway focused on measuring Rapid maxillary expansion, posterior crossbite, acoustic rhinometry

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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Tooth-borne (Hyrax) expander

    Tooth tissue-borne (KBME) expander

    Bone-borne (MIDME) expander

    Arm Description

    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

    Increasing nasal cavity area-1
    Increasing Minimum cross-sectional area1 (MCA1)
    Increasing nasal cavity area-2
    Minimum cross-sectional area2 (MCA2)
    Increasing nasal cavity volume
    Volume (Vol)

    Full Information

    First Posted
    August 21, 2020
    Last Updated
    August 26, 2020
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04529057
    Brief Title
    Evaluation of the Effect of Different Rapid Maxillary Expansion Appliances on Airway by Acoustic Rhinometry
    Official Title
    Evaluation of the Effect of Different Rapid Maxillary Expansion Appliances on Airway by Acoustic Rhinometry: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 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 an orthodontic treatment based on the principle of opening the midpalatal suture with the effect of orthopedic forces. The aim of this randomized clinical study was to evaluate and compare the effects of tooth-borne, tooth-tissue borne, and bone-borne rapid maxillary expanders on nasal airway by using AR. The null hypothesis was that there is no difference for the effect on nasal airway between the appliances.
    Detailed Description
    Introduction: The aim of this 3-arm parallel trial was to compare the effects of tooth-borne (Hyrax), tooth tissue-borne (KBME) and bone-borne (MIDME) rapid maxillary expansion (RME) appliances on nasal airway with acoustic rhinometry (AR). Methods: Fourty-six 12- to 14-years-old patients with narrow maxilla were randomly allocated into 3 study groups according to the type of RME appliance: tooth-borne, tooth tissue-borne and bone-borne. Participants were recruited from the Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Turkey. During the RME treatment, the same protocol was applied to all patients and the expansion screws were activated twice a day (0.4 mm/day). Computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. The outcome assessor was blinded; however, it was not feasible to blind either operator or patients. The primary outcome of this study was the correction of posterior crossbite. Secondary outcomes included AR assessment of nasal airway dimensions as nasal volume, the minimal cross-sectional area (MCA) 1 and 2. AR measurements were obtained before treatment (T0), after active expansion (T1), and at 3 months-follow-up (T2). One-way analysis of variance (ANOVA) and a Bonferroni test was used for inter-group comparison and two-way ANOVA was used for intra-group evalaution.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Crossbite, Upper Airway
    Keywords
    Rapid maxillary expansion, posterior crossbite, acoustic rhinometry

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Tooth-borne (Hyrax) expander
    Arm Type
    Experimental
    Arm Title
    Tooth tissue-borne (KBME) expander
    Arm Type
    Experimental
    Arm Title
    Bone-borne (MIDME) expander
    Arm Type
    Experimental
    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) (T1).
    Secondary Outcome Measure Information:
    Title
    Increasing nasal cavity area-1
    Description
    Increasing Minimum cross-sectional area1 (MCA1)
    Time Frame
    At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2)
    Title
    Increasing nasal cavity area-2
    Description
    Minimum cross-sectional area2 (MCA2)
    Time Frame
    At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2)
    Title
    Increasing nasal cavity volume
    Description
    Volume (Vol)
    Time Frame
    At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2)

    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, willingness to participate in the study 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35189449
    Citation
    Gokce G, Gode S, Ozturk A, Kirazli T, Veli I. Evaluation of the effects of different rapid maxillary expansion appliances on airway by acoustic rhinometry: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2022 Apr;155:111074. doi: 10.1016/j.ijporl.2022.111074. Epub 2022 Feb 15.
    Results Reference
    derived

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    Evaluation of the Effect of Different Rapid Maxillary Expansion Appliances on Airway by Acoustic Rhinometry

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