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

I

Izmir Katip Celebi University

Status

Completed

Conditions

Posterior Crossbite, Upper Airway

Treatments

Procedure: Rapid Maxillary Expansion Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04529057
TDR-SABE-0024

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

12 to 14 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 3 patient groups

Tooth-borne (Hyrax) expander
Experimental group
Treatment:
Procedure: Rapid Maxillary Expansion Treatment
Tooth tissue-borne (KBME) expander
Experimental group
Treatment:
Procedure: Rapid Maxillary Expansion Treatment
Bone-borne (MIDME) expander
Experimental group
Treatment:
Procedure: Rapid Maxillary Expansion Treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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