Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

Maxillary Constriction Clinical Trial

Official title:

Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02810353
• Other study ID #: Bauru Dental School, USP
• 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 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).

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

• Bilateral Posterior Crossbite
• Constriction, Pathologic
• Mandibular Dental Arch Constriction
• Maxillary Constriction
• Unilateral Posterior Crossbite

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