Dentoskeletal Effects of the Expander With Differential Opening and the Fan-type Expander

Malocclusion Clinical Trial

Official title:

Maxillary Expander With Differential Opening Versus Fan-type Expander: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705871
• Other study ID #: 71648917.6.0000.5417
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the dentoskeletal effects of two types of maxillary expanders in orthodontic patients in the mixed dentition, from 7 to 11 years old. Half of participants will be treated using the expander with differential opening, while the other half will undergo rapid maxillary expansion using the fan-type expander. The null hypothesis is that there is no difference between dentoskeletal effects of the two protocols.

Description:

Rapid maxillary expansion (RME) is the orthopedic procedure of choice to treat maxillary constriction and posterior crossbite, and the study of dental, skeletal and periodontal effects of this procedure has been widely discussed in the orthodontic literature. The conventional RME expanders promote a similar expansion in the anterior and posterior regions of the maxillary arch. On the other hand, the fan-type expander allows the expansion concentrated in the intercanine region with little effects the intermolar distance. Finally, the expander with differential opening has two palatal screws and the differential activation protocol promotes a different amount of expansion for the anterior and posterior regions of the maxilla. No clinical study compared dental and skeletal effects of the expander with differential opening with those of the fan-type expander, including a three-dimensional analysis using CBCT exams and digital dental models. So, the aim of the present randomized clinical trial is to compare the skeletal and dentoalveolar effects of the maxillary expander with differential opening and the fan-type expander in the mixed dentition.

For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. A sample of 48 patients from 7 to 11 years old with transverse maxillary dental arch constriction will be prospectively and randomly allocated into two study groups. The first group will consist of 24 individuals treated with the expander with differential opening (DEG). The second group will consist of 24 individuals treated with the fan-type expander (FEG). In 12 patients from each group (immediate subgroups), a cone-beam computed tomography (CBCT) will be performed in the beginning of treatment (T1) and immediately after the rapid maxillary expansion (T2). In the other 24 patients, 12 from DEG and 12 from FEG (late subgroups), a CBCT will be obtained at T1 and 6 months after maxillary expansion (T3). Dental models will be obtained for all patients at T1 and T3. In digital dental models, maxillary arch width, perimeter, length and shape will be assessed. Standardized CBCT coronal sections will be used for measuring maxillary transverse dimensions, nasal cavity width and posterior tooth inclinations. Segmentation and superimposition of T1 and T3 CBCT images at the cranial base will be also performed. The opening of the midpalatal suture at the anterior and posterior region and the geometry of the suture opening will be evaluated in axial reconstructions of the CBCT.Discomfort, pain and quality of life will be evaluated by questionnaires.

After the normality test, the paired t test will be used in the intragroup comparison, and the independent t test will be used in the intergroup comparison. In the case of lost to follow-up patients, intention to treat analysis will be used. A significance level of 5% will be regarded for all tests.

Possible harms that could appear are related to temporary discomfort during the first days after the installation of the expander. Patients and legal guardians will be carefully oriented and they will be able to stop the treatment at any moment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 1, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• Both sexes;

• Mixed dentition;

• Ages ranging from 7 to 11 years old;

• Maxillary constriction associated to posterior crossbites;

• Angle Class I or Angle Class II malocclusions.

Exclusion Criteria:

• Cleft lip and palate;

• Craniofacial syndromes;

• Carious lesions;

• Angle Class III malocclusion;

• History of previous orthodontic treatment.

Related Conditions & MeSH terms

• Crossbite (Posterior)
• Malocclusion

Intervention

Device:
• Differential Expansion
Twenty-four patients will be treated with a rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm in the anterior screw of the expander. 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.
• Fan-Fype Expander
Twenty-four patients will be treated with a rapid maxillary expansion using the fan-type expander. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm screw of the expander. 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.

Locations

Country	Name	City	State
Brazil	Bauru Dental School - University of São Paulo	Bauru	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maxillary and mandibular arch width (mm)	Measurements will be performed in digital dental models	6 months
Primary	Maxillary and mandibular arch length	Measurements will be performed in digital dental models	6 months
Primary	Maxillary and mandibular arch perimeter (mm)	Measurements will be performed in digital dental models	6 months
Primary	Nasal cavity width (mm)	Measurements will be performed in coronal sections of CBCT exams.	6 months
Primary	Maxillary width (mm)	Measurements will be performed in coronal sections of CBCT exams.	6 months
Primary	Maxillary molars inclination (°)	Measurement will be performed in CBCT scans.	6 months
Primary	Maxillary deciduous canines inclination (°)	Measurement be performed CBCT scans.	6 months
Primary	Amount of interincisor diastema (mm)	Measurement will be assessed in CBCT scans.	10 days
Primary	Opening of the midpalatal suture (mm)	Measurement be assessed in axial and coronal sections of CBCT scans.	10 days
Secondary	Discomfort evaluation using questionnaires	A Visual Analog Scale will be used from 0 to 10 cm.	1 month
Secondary	Quality of life evaluation using questionnaires	The Child Perceptions Questionnaire (CPQ8-10) will be used to evaluate the quality of life of the patients before and after treatment.	6 months
Secondary	Dentoskeletal displacements by three-dimensional superimposition of CBCT scams.		6 months