Clinical trial NCT03702881: Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs
Official title: Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Open Bite
Keywords: Open Bite
Orthodontic appliance
Cephalometry
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: 2018-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients. Half of participants will be treated with bonded spurs associated with build-ups, while the other half will be treated with conventional bonded spurs.

The null hypothesis to be tested is that there are no differences for the dentoalveolar and skeletal effects between the two protocols.

Detailed description: Anterior open bite is commonly related with lower anterior face height increase. Some early treatment protocols use appliances that control deleterious habits associated to appliances that produce control of the vertical dimension. Usually, these appliances (chincup, removable orthopedics) depend on patient's collaboration. Recently, the efficiency and stability of anterior open bite treatment with resin blocks bonded to the posterior teeth (build-ups) associated with fixed orthodontic appliances was described. They could be considered as a promissory alternative for vertical control during anterior open bite treatment. Then, it could be thought that the association of bonded spurs with posterior build-ups, instead of chincup, would produce vertical control during anterior open bite early treatment without the need of patient collaboration. Therefore, the aim of this study is to compare the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients.

For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. Fifty patients between 7 and 11 years old diagnosed with anterior open bite greater than 1 mm will be prospective and randomly allocated in one of the two study group. The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups. Control group will consist of 25 patients treated with conventional bonded spurs.

Lateral radiographs and digital dental models will be obtained at the beginning (T1), 12 months after treatment (T2), and 24 months after treatment (T3). Dentoalveolar and skeletal variables will be evaluated from the lateral radiographs in the Dolphin® software. Dental casts will be analyzed with the Orthoanalyzer® software to evaluate dentoalveolar anterior vertical development, posterior teeth inclinations and arch dimensions. Superimposition of digital dental models will be performed to evaluate the relative three-dimensional dentoalveolar changes on the maxillary and mandibular arches. Discomfort, pain and quality of life will be evaluated using questionnaires.

After verifying the normal distribution, intergroup comparisons (T1 vs T2 and T1 vs T3) will be performed with t test and intragroup comparisons with dependent t test. Results will be considered statistically significant at P\<0.05.

The possible harms that could appear with these therapies are related to temporary tongue discomfort during the first days after the installation of the appliances. Patients and parents will be informed that is it normal. Although it has been reported that the discomfort is temporary and transitory and usually patients adapted to the treatment after 3-5 days, patients or parents will be able to stop the treatment at any moment.

Eligibility criteria: Inclusion Criteria:

* Patients between 7 to 11 years old,
* erupted permanent first permanent molars,
* anterior open bite (AOB) greater than 1 mm,
* maxillary and mandibular permanent central incisors fully erupted,
* no or mild crowding,
* without the need of maxillary expansion
* Children in the first transitional period will be considered to be eligible for treatment when the maxillary lateral incisors are beginning to erupt and the maxillary central incisors still show an open bite

Exclusion Criteria:

* previous orthodontic treatment,
* craniofacial anomalies or syndromes,
* tooth agenesis,
* loss of permanent teeth,
* severe crowding,
* maxillary constriction or posterior crossbite

Primary outcomes:
measure: Overbite (mm)
timeFrame: 12 months
measure: Gonial angle (º)
timeFrame: 12 months
measure: Mandibular plane angle (º)
timeFrame: 12 months
measure: Maxillary and mandibular molar vertical development (mm)
timeFrame: 12 months
Secondary outcomes:
measure: Overbite (mm)
timeFrame: 24 months
measure: Gonial angle (º)
timeFrame: 24 months
measure: Mandibular plane angle (º)
timeFrame: 24 months
measure: Maxillary and mandibular molar vertical development (mm)
timeFrame: 24 months
measure: Maxillary and mandibular position (º)
timeFrame: 12 months
measure: Maxillary and mandibular position (º)
timeFrame: 24 months
measure: Maxillary and mandibular length (mm)
timeFrame: 12 months
measure: Maxillary and mandibular length (mm)
timeFrame: 24 months
measure: Mandibular ramus height (mm)
timeFrame: 12 months
measure: Mandibular ramus height (mm)
timeFrame: 24 months
measure: Sagittal skeletal discrepancy (º)
timeFrame: 12 months
measure: Sagittal skeletal discrepancy (º)
timeFrame: 24 months
measure: Facial axis angle (º)
timeFrame: 12 months
measure: Facial axis angle (º)
timeFrame: 24 months
measure: Maxillomandibular divergence angle (º)
timeFrame: 12 months
measure: Maxillomandibular divergence angle (º)
timeFrame: 24 months
measure: Palatal plane inclination (º)
timeFrame: 12 months
measure: Palatal plane inclination (º)
timeFrame: 24 months
measure: Anterior face height (mm)
timeFrame: 12 months
measure: Anterior face height (mm)
timeFrame: 24 months
measure: Posterior face height (mm)
timeFrame: 12 months
measure: Posterior face height (mm)
timeFrame: 24 months
measure: Lower anterior face height (mm)
timeFrame: 12 months
measure: Lower anterior face height (mm)
timeFrame: 24 months
measure: Overjet (mm)
timeFrame: 12 months
measure: Overjet (mm)
timeFrame: 24 months
measure: Maxillary and mandibular incisors Inclination (º)
timeFrame: 12 months
measure: Maxillary and mandibular incisors Inclination (º)
timeFrame: 24 months
measure: Maxillary and mandibular incisors position (mm)
timeFrame: 12 months
measure: Maxillary and mandibular incisors position (mm)
timeFrame: 24 months
measure: Maxillary and mandibular incisors height (mm)
timeFrame: 12 months
measure: Maxillary and mandibular incisors height (mm)
timeFrame: 24 months
measure: Nasolabial angle (º)
timeFrame: 12 months
measure: Nasolabial angle (º)
timeFrame: 24 months
measure: Upper lip inclination (º)
timeFrame: 12 months
measure: Upper lip inclination (º)
timeFrame: 24 months
measure: Upper and lower lip position (mm)
timeFrame: 12 months
measure: Upper and lower lip position (mm)
timeFrame: 24 months
measure: Interlabial gap (mm)
timeFrame: 12 months
measure: Interlabial gap (mm)
timeFrame: 24 months
measure: Maxillary and mandibular anterior dentoalveolar vertical development (mm)
timeFrame: 12 months
measure: Maxillary and mandibular anterior dentoalveolar vertical development (mm)
timeFrame: 24 months
measure: Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
timeFrame: 12 months
measure: Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
timeFrame: 24 months
measure: Maxillary and mandibular inter-first permanent molar distances (mm)
timeFrame: 12 months
measure: Maxillary and mandibular inter-first permanent molar distances (mm)
timeFrame: 24 months
measure: Maxillary and mandibular inter-canine distances (mm)
timeFrame: 12 months
measure: Maxillary and mandibular inter-canine distances (mm)
timeFrame: 24 months
measure: Maxillary and mandibular arch perimeters (mm)
timeFrame: 12 months
measure: Maxillary and mandibular arch perimeters (mm)
timeFrame: 24 months
measure: Maxillary and mandibular arch lengths (mm)
timeFrame: 12 months
measure: Maxillary and mandibular arch lengths (mm)
timeFrame: 24 months
measure: Palatal depth (mm)
timeFrame: 12 months
measure: Palatal depth (mm)
timeFrame: 24 months
measure: Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
timeFrame: 12 months
measure: Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
timeFrame: 24 months
measure: Discomfort and pain intensity evaluated with questionnaires
timeFrame: 1 month
measure: Discomfort and pain intensity evaluated with questionnaires
timeFrame: 12 months
measure: Discomfort and pain intensity evaluated with questionnaires
timeFrame: 24 months
measure: Parent´s perception of children discomfort and pain intensity evaluated with questionnaires
timeFrame: 1 month
measure: Quality of life evaluation with questionnaires
timeFrame: 12 months
measure: Quality of life evaluation with questionnaires
timeFrame: 24 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru Dental School, University of São Paulo
state: São Paulo
Study officials:
References:
citation: Aliaga-Del Castillo A, Janson G, Vilanova L, Cevidanes L, Yatabe M, Garib D, Arriola-Guillen LE, Miranda F, Massaro C, Bellini-Pereira SA, Ruellas AC. Three-dimensional dentoalveolar changes in open bite treatment in mixed dentition, spurs/posterior build-ups versus spurs alone: 1-year follow-up randomized clinical trial. Sci Rep. 2022 Jul 20;12(1):12378. doi: 10.1038/s41598-022-15988-9.
citation: Aliaga-Del Castillo A, Bellini-Pereira SA, Vilanova L, Miranda F, Massaro C, Arriola-Guillen LE, Garib D, Janson G. Dental arch changes after open bite treatment with spurs associated with posterior build-ups in the mixed dentition: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Jun;159(6):714-723.e1. doi: 10.1016/j.ajodo.2020.11.036. Epub 2021 Mar 30.
citation: Aliaga-Del Castillo A, Vilanova L, Miranda F, Arriola-Guillen LE, Garib D, Janson G. Dentoskeletal changes in open bite treatment using spurs and posterior build-ups: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Jan;159(1):10-20. doi: 10.1016/j.ajodo.2020.06.031. Epub 2020 Nov 18.