Maxillary and Mandibular Arch Response to RME: a Multicentric Randomized Controlled Trial

NCT02798822 | Completed

• 1 other identifier: 80911110
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

Brief Summary

Posterior crossbite is a common clinical condition often associated with transverse maxillary deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting and can lead to the development of craniofacial asymmetries and mandibular dysfunction. The aim of the current study was to evaluate maxillary and mandibular arch widths' response to RME when it is anchored to the upper second deciduous molars or to the upper first permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition patients.

Conditions

Posterior Crossbite

Outcome Measures

Primary Outcomes (1)

• Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts)

  5 months

Secondary Outcomes (10)

• Crossbite correction stability (binary outcome yes/no: clinical evaluation in vivo and measured on digital dental casts)

  10 months

• Canine angulation (degrees of transverse expansion measured on digital dental casts)

  5 months

• Canine angulation (degrees of transverse expansion measured on digital dental casts)

  10 months

• Molar angulation (degrees of transverse expansion measured on digital dental casts)

  5 months

• Molar angulation (degrees of transverse expansion measured on digital dental casts)

  10 months

Other Outcomes (2)

• Cephalometric evaluation of craniofacial growth (changes in mm and degrees of craniofacial skeletal growth measured on dental digital X-ray)

  10 months

• Cephalometric evaluation of morphology of the cervical vertebrae (changes in mm and degrees of cervical vertebrae morphology on dental digital X-ray)

  10 months

Study Arms (2)

RME on upper first permanent molars

ACTIVE COMPARATOR

Intervention/Procedure: Rapid maxillary expansion. When RME was in situ, patients started the screw activation (Snap-lock expander screw, Forestadent, Pforzheim, Germany) of one-quarter turn a day (0.22 mm) until overcorrection was achieved (ie, the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp), and the RME remained in place for 10 months. The screw was turned for 35 ± 6 days for Gr6, and the average treatment time was 12 ± 1.3 months.

Procedure: Rapid maxillary expansion

RME on upper second deciduous molars

ACTIVE COMPARATOR

Intervention/Procedure: Rapid maxillary expansion. When RME was in situ, patients started the screw activation (Snap-lock expander screw, Forestadent, Pforzheim, Germany) of one-quarter turn a day (0.22 mm) until overcorrection was achieved (ie, the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp), and the RME remained in place for 10 months. The screw was turned for 41 ± 8 days, and the average treatment time was 12 ± 1.3 months.

Procedure: Rapid maxillary expansion

Interventions

Rapid maxillary expansion PROCEDURE

When rapid maxillary expander was in-situ, patients waited 7 days before starting the screw activation of one quarter turn a day (0.22 mm) until overcorrection. Expansion was considered adequate when the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp. When was achieved, rapid maxillary expander stayed in place for 10 months.

RME on upper first permanent molars; RME on upper second deciduous molars

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients in mixed dentition
• Unilateral posterior crossbite at least of the first permanent molar
• Upper deciduous second molars available as RME anchoring teeth

You may not qualify if:

• Previous orthodontic treatment
• Hypodontia in any quadrant excluding third molars
• Inadequate oral hygiene
• Temporomandibular joint disorders
• Craniofacial abnormalities
• Lack of records
• Need for lingual arch
• Lack of consensus
• Need for other orthodontic treatment during rapid maxillary expansion

Sponsors & Collaborators

• University of Genova: lead

Study Sites (3)

Ortohdontic Department - Univesity of Genoa

Genova, 16100, Italy

Location

Ortohdontic Department - Univesity of Siena

Siena, Italy

Location

Orthodontic Department - University of Varese

Varese, Italy

Location

Related Publications (1)

• Cerruto C, Ugolini A, Di Vece L, Doldo T, Caprioglio A, Silvestrini-Biavati A. Cephalometric and dental arch changes to Haas-type rapid maxillary expander anchored to deciduous vs permanent molars: a multicenter, randomized controlled trial. J Orofac Orthop. 2017 Sep;78(5):385-393. doi: 10.1007/s00056-017-0092-2. Epub 2017 Apr 10.

  PMID: 28397083 DERIVED

Study Officials

• Alessandro Ugolini, DDS, PhD

  University of Genova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS MS PHD Researcher

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: June 14, 2016
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

IT (3)