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Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

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ClinicalTrials.gov Identifier: NCT02810353
Recruitment Status : Unknown
Verified June 2016 by Arthur César de Medeiros Alves, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Arthur César de Medeiros Alves, University of Sao Paulo

Brief Summary:
This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax expander.

Condition or disease Intervention/treatment Phase
Maxillary Constriction Unilateral Posterior Crossbite Bilateral Posterior Crossbite Mandibular Dental Arch Constriction Device: Differential rapid maxillary expansion Device: Conventional rapid maxillary expansion Not Applicable

Detailed Description:
Recently, a rapid maxillary expander with differential opening was developed aiming to treat maxillary constrictions greater in the anterior region compared to the posterior region of the maxillary dental arch. The aim of this study is to evaluate the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Material and methods: Fifty patients with maxillary constriction in the mixed dentition will be prospectively and randomly allocated in one of two study groups. The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion with the expander with differential opening. The control group will be comprised by 25 individuals who will undergo rapid maxillary expander with the Hyrax expander. Digital dental models will be acquired immediately pre-expansion (T1) and six months post-expansion (T2). The Orthoanalyzer™ software will be used to measure maxillary and mandibular widths, arches perimeter, arches lengths, palatal depth, and inclinations of maxillary and mandibular canines and permanent first molars. The intergroup and interphase comparisons will be analyzed using t tests and paired t tests, respectively (p<0.05).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial
Study Start Date : May 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Expander with differential opening group
The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion using the expander with differential opening. The expander will be composed by two 11-mm screws, one anteriorly and the other posteriorly positioned on the palate (Great lakes Orthodontics Ltd, NY, EUA).
Device: Differential rapid maxillary expansion
Twenty-five patients will be submitted to rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be provided by bands adapted either on the maxillary first permanent molars or on the second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. If the maxillary second deciduous molars will be banded, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars. Both anterior and posterior screws will be activated with a complete turn a day during 6 days. Then, only the anterior screw will be additionally activated for 4 more days. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months.
Other Name: RME with the expander with differential opening

Active Comparator: Hyrax group
The control group will be comprised by 25 patients who will undergo rapid maxillary expansion using the conventional Hyrax expander. The expander will be composed by one 11-mm screw centrally positioned on the palate (Dentaurum, Ispringen, Germany).
Device: Conventional rapid maxillary expansion
Twenty-five patients will undergo rapid maxillary expansion using conventional Hyrax expander. Bands will be adapted either on the maxillary first permanent molars or on second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. Similarly to the experimental group, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars if the maxillary second deciduous molars will be banded. The expander screw will be activated with a complete turn a day during 6 days. After the expansion active phase, the screw will be fixed with acrylic resin and the appliance will be kept in the dental arch as a retainer for 6 months.
Other Name: RME with the conventional Hyrax expander




Primary Outcome Measures :
  1. Maxillary and mandibular inter-first permanent molar distances [ Time Frame: 6 months ]
  2. Maxillary and mandibular inter-second deciduous molar distances [ Time Frame: 6 months ]
  3. Maxillary and mandibular inter-first deciduous molar distances [ Time Frame: 6 months ]
  4. Maxillary and mandibular inter-deciduous canine distances [ Time Frame: 6 months ]
  5. Maxillary and mandibular dental arches perimeters [ Time Frame: 6 months ]
  6. Maxillary and mandibular dental arches lengths [ Time Frame: 6 months ]
  7. Palatal depth [ Time Frame: 6 months ]
  8. Inclination of maxillary and mandibular first permanent molars [ Time Frame: 6 months ]
  9. Inclination of maxillary and mandibular deciduous canines [ Time Frame: 6 months ]
  10. Amount of interincisor diastema [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Amount of differential expansion on the maxillary and mandibular dental arches [ Time Frame: 6 months ]


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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both sexes;
  • Ages ranging from 7 to 11 years old;
  • Mixed dentition;
  • Maxillary constriction;
  • No previous orthodontic treatment.

Exclusion Criteria:

  • Cleft lip and palate and associated syndromes;
  • Systemic and/or neurological diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810353


Contacts
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Contact: Arthur Alves, DDS, MSc +55 14 981060878 arthurcesar_88@hotmail.com

Locations
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Brazil
University of São Paulo Recruiting
Bauru, São Paulo, Brazil, 17012059
Contact: Arthur Alves, DDS, MSc    +55 14 981060878    arthurcesar_88@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Arthur Alves, DDS, MSc Bauru Dental School, University of São Paulo
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Responsible Party: Arthur César de Medeiros Alves, University of São Paulo, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02810353    
Other Study ID Numbers: Bauru Dental School, USP
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malocclusion
Constriction, Pathologic
Pathological Conditions, Anatomical
Tooth Diseases
Stomatognathic Diseases