Evaluation of the Effect of Different Rapid Maxillary Expansion Appliances on Airway by Acoustic Rhinometry
- Conditions
- Posterior Crossbite, Upper Airway
- Interventions
- Procedure: Rapid Maxillary Expansion Treatment
- Registration Number
- NCT04529057
- Lead Sponsor
- Izmir Katip Celebi University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tooth-borne (Hyrax) expander Rapid Maxillary Expansion Treatment - Tooth tissue-borne (KBME) expander Rapid Maxillary Expansion Treatment - Bone-borne (MIDME) expander Rapid Maxillary Expansion Treatment -
- Primary Outcome Measures
Name Time Method Correction of posterior crossbite After active expansion (up to 3 weeks) (T1). The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
- Secondary Outcome Measures
Name Time Method Increasing nasal cavity area-1 At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2) Increasing Minimum cross-sectional area1 (MCA1)
Increasing nasal cavity area-2 At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2) Minimum cross-sectional area2 (MCA2)
Increasing nasal cavity volume At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2) Volume (Vol)