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Maxillary and Mandibular Arch Response to RME: a Multicentric Randomized Controlled Trial (6vsE)

Primary Purpose

Posterior Crossbite

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rapid maxillary expansion
Sponsored by
University of Genova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Crossbite

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ortohdontic Department - Univesity of Genoa
  • Ortohdontic Department - Univesity of Siena
  • Orthodontic Department - University of Varese

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RME on upper first permanent molars

RME on upper second deciduous molars

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Crossbite correction stability (binary outcome yes/no: clinical evaluation in vivo and measured on digital dental casts)
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Molar expansion (mm of transverse expansion measured on digital dental casts)
Molar expansion (mm of transverse expansion measured on digital dental casts)
Canine Expansion (mm of transverse expansion measured on digital dental casts)
Canine Expansion (mm of transverse expansion measured on digital dental casts)
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)

Full Information

First Posted
August 2, 2013
Last Updated
June 8, 2016
Sponsor
University of Genova
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1. Study Identification

Unique Protocol Identification Number
NCT02798822
Brief Title
Maxillary and Mandibular Arch Response to RME: a Multicentric Randomized Controlled Trial
Acronym
6vsE
Official Title
Dental Arches Response to Haas-type RME Anchored to Deciduous vs Permanent Molars in Children With Unilateral Posterior Crossbite
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Genova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Crossbite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RME on upper first permanent molars
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RME on upper second deciduous molars
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rapid maxillary expansion
Intervention Description
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 Outcome Measure Information:
Title
Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts)
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Crossbite correction stability (binary outcome yes/no: clinical evaluation in vivo and measured on digital dental casts)
Time Frame
10 months
Title
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Time Frame
5 months
Title
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Time Frame
10 months
Title
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Time Frame
5 months
Title
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Time Frame
10 months
Title
Molar expansion (mm of transverse expansion measured on digital dental casts)
Time Frame
5 months
Title
Molar expansion (mm of transverse expansion measured on digital dental casts)
Time Frame
10 months
Title
Canine Expansion (mm of transverse expansion measured on digital dental casts)
Time Frame
5 months
Title
Canine Expansion (mm of transverse expansion measured on digital dental casts)
Time Frame
10 months
Title
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 Pre-specified Outcome Measures:
Title
Cephalometric evaluation of craniofacial growth (changes in mm and degrees of craniofacial skeletal growth measured on dental digital X-ray)
Time Frame
10 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Ugolini, DDS, PhD
Organizational Affiliation
University of Genova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ortohdontic Department - Univesity of Genoa
City
Genova
ZIP/Postal Code
16100
Country
Italy
Facility Name
Ortohdontic Department - Univesity of Siena
City
Siena
Country
Italy
Facility Name
Orthodontic Department - University of Varese
City
Varese
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28397083
Citation
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.
Results Reference
derived

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

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