Clinical trial NCT03846518: Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion
Official title: Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion: Dentoalveolar Effects and Impact on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Posterior Crossbite
Keywords: palatal expansion technique
adolescent
quality of life
Lead sponsor: Pontifícia Universidade Católica de Minas Gerais
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2019-02-19
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups: control group (Hyrax) and experimental group (mini Hyrax)
Primary purpose: TREATMENT

Brief summary: This study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander. The null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.

Detailed description: Transverse maxilla deficiency is characterized by narrowing of the maxillary arch with important functional and esthetic impact. In individuals which have not reached bone maturity, a rapid expansion of the maxilla by using tooth-borne expanders as Haas and Hyrax appliance are efficient and safe. A presentation of favorable results for the "mini-Hyrax inverted" expander with a small screw in the transversal correction of the maxilla in patients with cleft lip and palate, besides improving the comfort and the teeth cleaning, provoked an idea of application of this small screw to correct posterior crossbite in individuals without cleft lip and palate. The objective of this study is to compare the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in adolescent patients with permanent dentition and active bone growth. The sample size calculation indicated a total sample of 28 individuals. Taking into account the loss of sample during the study, 34 subjects that have posterior crossbite and age from 12 to 16 years, will be recruited at the Dental School, Pontifical University Catholic of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. These patients will be randomly divided into two groups, Hyrax and mini Hyrax, with 17 patients each. Digital models of both dental arches will be obtained by intraoral scanning precede the procedure (T0) and at the end of the retention period, after appliance removal (T2). OHIP-14 Oral Health Impact Profile Questionnaires, validated in Portuguese, will be applied before expansion (T0), after an expansion (T1) and at the end of the retention period (T2). In digital dental models, maxillary first and second bicuspids and first molar width, and rotation and inclination of maxillary first bicuspids and first molars will be assessed. After the normality test, the appropriate statistical test will be used in the intergroup comparison. A significance level of 5% will be regarded for all tests.

Eligibility criteria: Inclusion Criteria:

* Maxillary permanent dentition, except canines
* Ages ranging from 12 to 16 years old;
* Maxillary constriction associated to posterior crossbite uni or bilateral.

Exclusion Criteria:

* Cleft lip and palate;
* Craniofacial syndromes;
* Carious lesions;
* History of previous orthodontic treatment.

Primary outcomes:
measure: Maxillary first molars width. Scale in millimeters and one decimal place.
timeFrame: 6 months
measure: Maxillary first bicuspid width. Scale in millimeters and one decimal place.
timeFrame: 6 months
measure: Maxillary second bicuspid width. Scale in millimeters and one decimal place.
timeFrame: 6 months
measure: Maxillary first molas angulation. Scale in degrees and one decimal place.
timeFrame: 6 months
measure: Maxillary first bicuspids angulation. Scale in degrees and one decimal place.
timeFrame: 6 months
measure: Maxillary first molas inclination. Scale in degrees and one decimal place.
timeFrame: 6 months
measure: Maxillary first bicuspids inclination. Scale in degrees and one decimal place.
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life evaluation using questionnaires
timeFrame: 2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device)
measure: Discomfort evaluation using questionnaires
timeFrame: 24 hours (4 times: 0, 24, 48 and 72 hours after insert of device) and 1 week (2 times: 1 and 2 weeks after insert of device)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Pontifícia Universidade Católica de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Associate professor and program director of Orthodontics
name: Dauro D Oliveira, PhD
role: STUDY_CHAIR
References: