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

NCT04529057 | Completed

• 1 other identifier: TDR-SABE-0024
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Posterior Crossbite, Upper Airway

Keywords

Rapid maxillary expansion, posterior crossbite, acoustic rhinometry

Outcome Measures

Primary Outcomes (1)

• Correction of posterior crossbite

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

  After active expansion (up to 3 weeks) (T1).

Secondary Outcomes (3)

• Increasing nasal cavity area-1

  At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2)

• Increasing nasal cavity area-2

  At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2)

• Increasing nasal cavity volume

  At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2)

Study Arms (3)

Tooth-borne (Hyrax) expander

EXPERIMENTAL

Procedure: Rapid Maxillary Expansion Treatment

Tooth tissue-borne (KBME) expander

EXPERIMENTAL

Procedure: Rapid Maxillary Expansion Treatment

Bone-borne (MIDME) expander

EXPERIMENTAL

Procedure: Rapid Maxillary Expansion Treatment

Interventions

Rapid Maxillary Expansion Treatment PROCEDURE

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.

Bone-borne (MIDME) expander; Tooth tissue-borne (KBME) expander; Tooth-borne (Hyrax) expander

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Related Publications (1)

• 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.

  PMID: 35189449 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 3-arm parallel trial

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 27, 2020
• Study Start: July 1, 2016
• Primary Completion: January 13, 2017
• Study Completion: May 17, 2017
• Last Updated: August 27, 2020

Record last verified: 2020-08