Maxillary and Mandibular Arch Response to RME: a Multicentric Randomized Controlled Trial
NCT ID: NCT02798822
Last Updated: 2016-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2013-06-30
2015-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Unilateral posterior crossbite at least of the first permanent molar
* Upper deciduous second molars available as RME anchoring teeth
Exclusion Criteria
* 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
8 Years
10 Years
ALL
No
Sponsors
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University of Genova
OTHER
Responsible Party
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ALESSANDRO UGOLINI
DDS MS PHD Researcher
Principal Investigators
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Alessandro Ugolini, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Genova
Locations
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Ortohdontic Department - Univesity of Genoa
Genova, , Italy
Ortohdontic Department - Univesity of Siena
Siena, , Italy
Orthodontic Department - University of Varese
Varese, , Italy
Countries
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References
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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.
Other Identifiers
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80911110
Identifier Type: -
Identifier Source: org_study_id
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