Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs: a Randomized Clinical Trial.

Conditions
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Malocclusion, Open Bite

Intervention / Treatment
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* Device: Bonded Spurs associated with posterior build-ups
* Device: Conventional bonded spurs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bonded Spurs associated with posterior build-ups Group<br>The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups. | Device: Bonded Spurs associated with posterior build-ups<br>* Twenty-five patients will be treated with bonded spurs associated with posterior build-ups. The cervical portion of the palatal surfaces of the maxillary incisors and the incisal portion of the lingual surfaces of the mandibular incisors will be pumiced, rinsed, dried, and acid etched with 37% phosphoric acid. The etched surfaces will be subsequently rinsed and carefully dried. Then, the spurs will be bonded using Transbond primer/adhesive. The positions for the spurs will be chose to prevent possible future occlusal interferences The spurs will be sharpened with a carborundum disk before bonding. In addition, posterior build-ups (resin blocks) will be cemented on the functional cusps of all maxillary posterior teeth. The treatment time will be 12 months. After this time, the posterior build ups will be removed and the bonded spurs will be maintained for 12 months more, as active retention.<br>|
| Active Comparator: Conventional bonded spurs Group<br>Active comparator group will consist of 25 patients treated with conventional bonded spurs | Device: Conventional bonded spurs<br>* Twenty-five patients will be treated only with bonded spurs. The bonding of the spurs will follow the same protocol described for the experimental group. The treatment time will be 12 months. After this time, the bonded spurs will be maintained for 12 months more, as active retention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overbite (mm) |  | 12 months | 
| Gonial angle (º) |  | 12 months | 
| Mandibular plane angle (º) |  | 12 months | 
| Maxillary and mandibular molar vertical development (mm) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overbite (mm) |  | 24 months | 
| Gonial angle (º) |  | 24 months | 
| Mandibular plane angle (º) |  | 24 months | 
| Maxillary and mandibular molar vertical development (mm) |  | 24 months | 
| Maxillary and mandibular position (º) |  | 12 months | 
| Maxillary and mandibular position (º) |  | 24 months | 
| Maxillary and mandibular length (mm) |  | 12 months | 
| Maxillary and mandibular length (mm) |  | 24 months | 
| Mandibular ramus height (mm) |  | 12 months | 
| Mandibular ramus height (mm) |  | 24 months | 
| Sagittal skeletal discrepancy (º) |  | 12 months | 
| Sagittal skeletal discrepancy (º) |  | 24 months | 
| Facial axis angle (º) |  | 12 months | 
| Facial axis angle (º) |  | 24 months | 
| Maxillomandibular divergence angle (º) |  | 12 months | 
| Maxillomandibular divergence angle (º) |  | 24 months | 
| Palatal plane inclination (º) |  | 12 months | 
| Palatal plane inclination (º) |  | 24 months | 
| Anterior face height (mm) |  | 12 months | 
| Anterior face height (mm) |  | 24 months | 
| Posterior face height (mm) |  | 12 months | 
| Posterior face height (mm) |  | 24 months | 
| Lower anterior face height (mm) |  | 12 months | 
| Lower anterior face height (mm) |  | 24 months | 
| Overjet (mm) |  | 12 months | 
| Overjet (mm) |  | 24 months | 
| Maxillary and mandibular incisors Inclination (º) |  | 12 months | 
| Maxillary and mandibular incisors Inclination (º) |  | 24 months | 
| Maxillary and mandibular incisors position (mm) |  | 12 months | 
| Maxillary and mandibular incisors position (mm) |  | 24 months | 
| Maxillary and mandibular incisors height (mm) |  | 12 months | 
| Maxillary and mandibular incisors height (mm) |  | 24 months | 
| Nasolabial angle (º) |  | 12 months | 
| Nasolabial angle (º) |  | 24 months | 
| Upper lip inclination (º) |  | 12 months | 
| Upper lip inclination (º) |  | 24 months | 
| Upper and lower lip position (mm) |  | 12 months | 
| Upper and lower lip position (mm) |  | 24 months | 
| Interlabial gap (mm) |  | 12 months | 
| Interlabial gap (mm) |  | 24 months | 
| Maxillary and mandibular anterior dentoalveolar vertical development (mm) |  | 12 months | 
| Maxillary and mandibular anterior dentoalveolar vertical development (mm) |  | 24 months | 
| Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º) |  | 12 months | 
| Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º) |  | 24 months | 
| Maxillary and mandibular inter-first permanent molar distances (mm) |  | 12 months | 
| Maxillary and mandibular inter-first permanent molar distances (mm) |  | 24 months | 
| Maxillary and mandibular inter-canine distances (mm) |  | 12 months | 
| Maxillary and mandibular inter-canine distances (mm) |  | 24 months | 
| Maxillary and mandibular arch perimeters (mm) |  | 12 months | 
| Maxillary and mandibular arch perimeters (mm) |  | 24 months | 
| Maxillary and mandibular arch lengths (mm) |  | 12 months | 
| Maxillary and mandibular arch lengths (mm) |  | 24 months | 
| Palatal depth (mm) |  | 12 months | 
| Palatal depth (mm) |  | 24 months | 
| Dentoalveolar displacements obtained from three-dimensional superimposition (mm) |  | 12 months | 
| Dentoalveolar displacements obtained from three-dimensional superimposition (mm) |  | 24 months | 
| Discomfort and pain intensity evaluated with questionnaires | A 10-cm Visual Analog Scale will be used, where 0-cm is the minimum score indicating nor discomfort or pain intensity and 10-cm is the maximum score denoting the greatest discomfort or pain intensity. | 1 month | 
| Discomfort and pain intensity evaluated with questionnaires | A 10-cm Visual Analog Scale will be used, where 0-cm is the minimum score indicating nor discomfort or pain intensity and 10-cm is the maximum score denoting the greatest discomfort or pain intensity. | 12 months | 
| Discomfort and pain intensity evaluated with questionnaires | A 10-cm Visual Analog Scale will be used, where 0-cm is the minimum score indicating nor discomfort or pain intensity and 10-cm is the maximum score denoting the greatest discomfort or pain intensity. | 24 months | 
| Parent´s perception of children discomfort and pain intensity evaluated with questionnaires | A 10-cm Visual Analog Scale will be used, where 0-cm is the minimum score indicating nor discomfort or pain intensity and 10-cm is the maximum score denoting the greatest discomfort or pain intensity. | 1 month | 
| Quality of life evaluation with questionnaires | Oral health related-quality of life evaluation will be performed with the Child Perceptions Questionnaire (CPQ8-10). The questionnaire contains 25 items distributed in four domains: oral symptoms, functional limitations, emotional wellbeing and social wellbeing. The items assess the frequency of the events that occurs in the four weeks previous to the application of the questionnaire. A 5-point Likert scale is used with the options: Never (0), Once/twice (1), Sometimes (2), Often (3), and Every day/almost every day (4). The CPQ8-10 scores are obtained by summing all item scores. The total score ranges from 0 indicating no impact of oral condition on quality of life, to 100 indicating maximal impact of oral condition on quality of life. | 12 months | 
| Quality of life evaluation with questionnaires | Oral health related-quality of life evaluation will be performed with the Child Perceptions Questionnaire (CPQ8-10). The questionnaire contains 25 items distributed in four domains: oral symptoms, functional limitations, emotional wellbeing and social wellbeing. The items assess the frequency of the events that occurs in the four weeks previous to the application of the questionnaire. A 5-point Likert scale is used with the options: Never (0), Once/twice (1), Sometimes (2), Often (3), and Every day/almost every day (4). The CPQ8-10 scores are obtained by summing all item scores. The total score ranges from 0 indicating no impact of oral condition on quality of life, to 100 indicating maximal impact of oral condition on quality of life. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Bite, Orthodontic appliance, Cephalometry, Dental models