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
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
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.
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
NCT ID
NCT04529057
First Posted
August 21, 2020
Last Updated
August 26, 2020
Sponsor
Izmir Katip Celebi University
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
Learn more about this trial
Evaluation of the Effect of Different Rapid Maxillary Expansion Appliances on Airway by Acoustic Rhinometry
We'll reach out to this number within 24 hrs