Clinical trial NCT03712007: Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols
Official title: Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class III
Crossbite (Anterior) (Posterior)
Keywords: Orthodontic Anchorage Procedures
Malocclusion, Angle Class III
Palatal Expansion Technique.
Cone-Beam Computed Tomography
Dental Models
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-10-19
Enrollment: 35
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the dentoskeletal effects produced by two maxillary protraction protocols in adolescent patients. Half of participants will be treated with a tooth-borne and tooth-bone-borne expanders as anchorage in the maxillary arch. Miniscrews will be used as anchorage in the mandibular arch for both groups.

Detailed description: Class III malocclusion treatment in growing patients is challenging. A new treatment for maxillary protraction using skeletal anchorage reported an efficient maxillary protraction in the late mixed dentition an early permanent dentition. Therefore, the aim of this study is to compare the dentoskeletal effects produced by two maxillary protraction protocols anchored on miniscrews.

The sample will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. A sample of thirty-five patients, between 9 and 13 years old will be selected. The inclusion criteria are: Class III malocclusion associated with anterior crossbite. The participants will be allocated into 2 groups. Group 1 will comprise 20 individuals treated with a tooth-bone-borne expander and 2 miniscrews in the mandible Group 2 will comprise 15 individuals treated with a tooth-borne expander and 2 miniscrews in the mandible. Digital models and cone-beam computed tomography (CBCT) will be obtained before (T1) and 12 months after treatment (T2). Occlusal radiographs and partial (canine to canine) models will be obtained before and immediately after expansion. Two-dimensional cephalometric evaluations will be performed in the Dolphin® software. The arch width, arch perimeter and arch length will be analyzed with the Orthoanalyzer® software. Three-dimensional superimposition at the cranial base of T1 and T2 CBCT images will be performed. The inter incisor diastema will be evaluated by occlusal radiographs and dental models. Discomfort, pain and quality of life will evaluated by questionnaires. After verifying the normal distribution, the intragroup comparison will be performed with paired t test and intergroup comparison will be performed with t test. 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.

Temporary pain and discomfort are possible after the installation of the miniscrews. Patients and legal guardians will be informed. After the consent, the treatment can be stoped at any time.

Eligibility criteria: Inclusion Criteria:

* Both sexes;
* Ages ranging from 9 to 13 years old;
* Class III malocclusion;
* Mandibular canines erupted.

Exclusion Criteria:

* Previous orthodontic treatment;
* Cleft lip and palate;
* Craniofacial syndromes;
* Systemic and/or neurological diseases.

Primary outcomes:
measure: Maxillary sagittal skeletal discrepancy
timeFrame: 12 months
measure: Mandibular sagittal skeletal discrepancy
timeFrame: 12 months
measure: Vertical skeletal discrepancy
timeFrame: 12 months
measure: Teeth discrepancy
timeFrame: 12 months
measure: Soft tissue discrepancy
timeFrame: 12 months
Secondary outcomes:
measure: Maxillary and mandibular inter-first permanent molar distances
timeFrame: 12 months
measure: Maxillary and mandibular intercanine distances
timeFrame: 12 months
measure: Maxillary and mandibular dental arches perimeters
timeFrame: 12 months
measure: Maxillary and mandibular dental arches lengths
timeFrame: 12 months
measure: Inclination of maxillary and mandibular first permanent molars
timeFrame: 12 months
measure: Amount of interincisor diastema
timeFrame: 7 days
measure: Three-dimensional changes
timeFrame: 12 months
measure: Discomfort and pain
timeFrame: 1 month
measure: Parents perception of pain
timeFrame: 1 month
measure: Quality of life evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: University of São Paulo
state: São Paulo
Study officials:
References:
citation: Miranda F, Cunha Bastos JCD, Magno Dos Santos A, Janson G, Pereira Lauris JR, Garib D. Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Dec;160(6):774-783. doi: 10.1016/j.ajodo.2021.02.017. Epub 2021 Sep 9.
citation: Miranda F, Garib D, Pugliese F, da Cunha Bastos JC, Janson G, Palomo JM. Upper airway changes in Class III patients using miniscrew-anchored maxillary protraction with hybrid and hyrax expanders: a randomized controlled trial. Clin Oral Investig. 2022 Jan;26(1):183-195. doi: 10.1007/s00784-021-03989-3. Epub 2021 May 27.