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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bonded Spurs associated with posterior build-ups Group | Experimental | The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups. |
|
| Conventional bonded spurs Group | Active Comparator | Active comparator group will consist of 25 patients treated with conventional bonded spurs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bonded Spurs associated with posterior build-ups | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overbite (mm) | 24 months | |
| Gonial angle (º) | 24 months | |
| Mandibular plane angle (º) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bauru Dental School, University of São Paulo | Bauru | São Paulo | 17012901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38459254 | Derived | Aliaga-Del Castillo A, Maranon-Vasquez GA, Janson G, Vilanova L, Miranda F, Massaro C, Bellini-Pereira SA, Arriola-Guillen LE, Yatabe M, Ruellas AC, Cevidanes L, Garib D. Oral health-related quality of life, adaptation/discomfort during open bite treatment with spurs: complementary analysis from a randomized clinical trial. Sci Rep. 2024 Mar 8;14(1):5732. doi: 10.1038/s41598-024-56363-0. | |
| 35858941 |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D024343 | Open Bite |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Conventional bonded spurs | Device | 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. |
|
| 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 |
| Derived |
| 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. |
| 33795189 | Derived | 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. |
| 33221096 | Derived | 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. |