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Completed

NCT Number: NCT02798822

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

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.

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Key information

Conditions

Posterior Crossbite

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ortohdontic Department - Univesity of Genoa, Genova, Italy

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About this study

The effects of rapid maxillary expansion (RME) on the maxillary complex have been highly investigated,4 reporting a maximum maxillary intermolar and intercanine width increase of 6.7 mm and 5.3 mm,5 respectively, when RME is banded on upper first permanent molars.

Literature also reported cases of periodontal and endodontic damage on RME anchoring teeth; therefore, some authors have suggested banding RME on primary teeth and reporting also different mean intermolar (3.6-4.1 mm) and intercanine width increases (5-5.9 mm).

Few studies have investigated the changes in molar dental tipping and inclinations (on average from 3° up to 16.7°) following RME but comprised difficult (ie, barium sulfate solution) and more invasive examinations such as computed tomography and cone beam computed tomography (CBCT) Few articles concerning the indirect effects on mandibular arch following RME reported a low but statistically significant increase of lower intermolar (0.66-0.97 mm) and intercanine width (0.9 mm). Since no studies in the literature have analyzed the differences in permanent vs primary molars as anchoring teeth for RME, the decision to band the permanent deciduous molars did not follow a clinical protocol, but an individual decision was made for each patient based on clinician experience.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Primary exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 5 months

Secondary outcomes

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

    Time frame: 10 months

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

    Time frame: 5 months

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

    Time frame: 10 months

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

    Time frame: 5 months

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

    Time frame: 10 months

  6. Molar expansion (mm of transverse expansion measured on digital dental casts)

    Time frame: 5 months

  7. Molar expansion (mm of transverse expansion measured on digital dental casts)

    Time frame: 10 months

  8. Canine Expansion (mm of transverse expansion measured on digital dental casts)

    Time frame: 5 months

  9. Canine Expansion (mm of transverse expansion measured on digital dental casts)

    Time frame: 10 months

  10. Upper and lower incisor angulation and rotation (changes in mm and degrees of dental angulation and rotation measured on digital dental casts and Dental digital X-ray)

    Time frame: 10 months

Other outcomes

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

    Time frame: 10 months

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

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Registry information

Official study title

Dental Arches Response to Haas-type RME Anchored to Deciduous vs Permanent Molars in Children With Unilateral Posterior Crossbite

Acronym: 6vsE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 14, 2016
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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