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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02810353
Other study ID # Bauru Dental School, USP
Secondary ID
Status Recruiting
Phase N/A
First received June 18, 2016
Last updated June 18, 2016
Start date May 2015
Est. completion date February 2018

Study information

Verified date June 2016
Source University of Sao Paulo
Contact Arthur Alves, DDS, MSc
Phone +55 14 981060878
Email arthurcesar_88@hotmail.com
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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 Orthoanalyzerâ„¢ 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date February 2018
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 11 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Brazil University of São Paulo Bauru São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maxillary and mandibular inter-first permanent molar distances 6 months Yes
Primary Maxillary and mandibular inter-second deciduous molar distances 6 months Yes
Primary Maxillary and mandibular inter-first deciduous molar distances 6 months Yes
Primary Maxillary and mandibular inter-deciduous canine distances 6 months Yes
Primary Maxillary and mandibular dental arches perimeters 6 months Yes
Primary Maxillary and mandibular dental arches lengths 6 months Yes
Primary Palatal depth 6 months Yes
Primary Inclination of maxillary and mandibular first permanent molars 6 months Yes
Primary Inclination of maxillary and mandibular deciduous canines 6 months Yes
Primary Amount of interincisor diastema 10 days Yes
Secondary Amount of differential expansion on the maxillary and mandibular dental arches 6 months Yes
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