An interventional study of Bonded Spurs associated with posterior build-ups and Conventional bonded spurs in Malocclusion and Open Bite, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.
Device: Bonded Spurs associated with posterior build-ups
Active comparator group will consist of 25 patients treated with conventional bonded spurs
Device: Conventional bonded spurs
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.
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.
Overbite (mm)
Time frame: 12 months
Gonial angle (º)
Time frame: 12 months
Mandibular plane angle (º)
Time frame: 12 months
Maxillary and mandibular molar vertical development (mm)
Time frame: 12 months
Overbite (mm)
Time frame: 24 months
Gonial angle (º)
Time frame: 24 months
Mandibular plane angle (º)
Time frame: 24 months
Maxillary and mandibular molar vertical development (mm)
Time frame: 24 months
Maxillary and mandibular position (º)
Time frame: 12 months
Maxillary and mandibular position (º)
Time frame: 24 months
Maxillary and mandibular length (mm)
Time frame: 12 months
Maxillary and mandibular length (mm)
Time frame: 24 months
Mandibular ramus height (mm)
Time frame: 12 months
Mandibular ramus height (mm)
Time frame: 24 months
Sagittal skeletal discrepancy (º)
Time frame: 12 months
Sagittal skeletal discrepancy (º)
Time frame: 24 months
Facial axis angle (º)
Time frame: 12 months
Facial axis angle (º)
Time frame: 24 months
Maxillomandibular divergence angle (º)
Time frame: 12 months
Maxillomandibular divergence angle (º)
Time frame: 24 months
Palatal plane inclination (º)
Time frame: 12 months
Palatal plane inclination (º)
Time frame: 24 months
Anterior face height (mm)
Time frame: 12 months
Anterior face height (mm)
Time frame: 24 months
Posterior face height (mm)
Time frame: 12 months
Posterior face height (mm)
Time frame: 24 months
Lower anterior face height (mm)
Time frame: 12 months
Lower anterior face height (mm)
Time frame: 24 months
Overjet (mm)
Time frame: 12 months
Overjet (mm)
Time frame: 24 months
Maxillary and mandibular incisors Inclination (º)
Time frame: 12 months
Maxillary and mandibular incisors Inclination (º)
Time frame: 24 months
Maxillary and mandibular incisors position (mm)
Time frame: 12 months
Maxillary and mandibular incisors position (mm)
Time frame: 24 months
Maxillary and mandibular incisors height (mm)
Time frame: 12 months
Maxillary and mandibular incisors height (mm)
Time frame: 24 months
Nasolabial angle (º)
Time frame: 12 months
Nasolabial angle (º)
Time frame: 24 months
Upper lip inclination (º)
Time frame: 12 months
Upper lip inclination (º)
Time frame: 24 months
Upper and lower lip position (mm)
Time frame: 12 months
Upper and lower lip position (mm)
Time frame: 24 months
Interlabial gap (mm)
Time frame: 12 months
Interlabial gap (mm)
Time frame: 24 months
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Time frame: 12 months
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Time frame: 24 months
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Time frame: 12 months
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Time frame: 24 months
Maxillary and mandibular inter-first permanent molar distances (mm)
Time frame: 12 months
Maxillary and mandibular inter-first permanent molar distances (mm)
Time frame: 24 months
Maxillary and mandibular inter-canine distances (mm)
Time frame: 12 months
Maxillary and mandibular inter-canine distances (mm)
Time frame: 24 months
Maxillary and mandibular arch perimeters (mm)
Time frame: 12 months
Maxillary and mandibular arch perimeters (mm)
Time frame: 24 months
Maxillary and mandibular arch lengths (mm)
Time frame: 12 months
Maxillary and mandibular arch lengths (mm)
Time frame: 24 months
Palatal depth (mm)
Time frame: 12 months
Palatal depth (mm)
Time frame: 24 months
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
Time frame: 12 months
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Plan to share: No
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University of Sao Paulo