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

Sponsor

University of Genova (Other)

Overall Status

Completed

CT.gov ID

NCT02798822

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

29.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posterior Crossbite	Procedure: Rapid maxillary expansion	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RME on upper first permanent molars 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 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.
Active Comparator: RME on upper second deciduous molars 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 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.

Arm

Intervention/Treatment

Active Comparator: RME on upper first permanent molars

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

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.

Active Comparator: RME on upper second deciduous molars

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

Outcome Measures

Primary Outcome Measures

Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts) [5 months]

Secondary Outcome Measures

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]
Molar expansion (mm of transverse expansion measured on digital dental casts) [5 months]
Molar expansion (mm of transverse expansion measured on digital dental casts) [10 months]
Canine Expansion (mm of transverse expansion measured on digital dental casts) [5 months]
Canine Expansion (mm of transverse expansion measured on digital dental casts) [10 months]
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) [10 months]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ortohdontic Department - Univesity of Genoa	Genova	Italy	16100
2	Ortohdontic Department - Univesity of Siena	Siena	Italy
3	Orthodontic Department - University of Varese	Varese	Italy

Sponsors and Collaborators

University of Genova

Investigators

Principal Investigator: Alessandro Ugolini, DDS, PhD, University of Genova

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ALESSANDRO UGOLINI, DDS MS PHD Researcher, University of Genova

ClinicalTrials.gov Identifier:

NCT02798822

Other Study ID Numbers:

80911110

First Posted:

Jun 14, 2016

Last Update Posted:

Jun 14, 2016

Last Verified:

Jun 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Malocclusion

Study Results

No Results Posted as of Jun 14, 2016