Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs
- Conditions
- MalocclusionOpen Bite
- Interventions
- Device: Conventional bonded spursDevice: Bonded Spurs associated with posterior build-ups
- Registration Number
- NCT03702881
- Lead Sponsor
- University of Sao Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- previous orthodontic treatment,
- craniofacial anomalies or syndromes,
- tooth agenesis,
- loss of permanent teeth,
- severe crowding,
- maxillary constriction or posterior crossbite
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional bonded spurs Group Conventional bonded spurs Active comparator group will consist of 25 patients treated with conventional bonded spurs Bonded Spurs associated with posterior build-ups Group Bonded Spurs associated with posterior build-ups The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.
- Primary Outcome Measures
Name Time Method Gonial angle (º) 12 months Overbite (mm) 12 months Mandibular plane angle (º) 12 months Maxillary and mandibular molar vertical development (mm) 12 months
- Secondary Outcome Measures
Name Time Method Maxillomandibular divergence angle (º) 24 months Gonial angle (º) 24 months Maxillary and mandibular incisors Inclination (º) 24 months Interlabial gap (mm) 24 months Maxillary and mandibular anterior dentoalveolar vertical development (mm) 24 months Maxillary and mandibular inter-canine distances (mm) 24 months Mandibular ramus height (mm) 24 months Sagittal skeletal discrepancy (º) 24 months Palatal plane inclination (º) 24 months Anterior face height (mm) 24 months Maxillary and mandibular incisors height (mm) 24 months Upper lip inclination (º) 24 months Upper and lower lip position (mm) 24 months Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º) 24 months Maxillary and mandibular inter-first permanent molar distances (mm) 24 months Dentoalveolar displacements obtained from three-dimensional superimposition (mm) 24 months Overbite (mm) 24 months Maxillary and mandibular molar vertical development (mm) 24 months Mandibular plane angle (º) 24 months Maxillary and mandibular position (º) 24 months Facial axis angle (º) 24 months Maxillary and mandibular arch lengths (mm) 24 months Palatal depth (mm) 24 months Maxillary and mandibular length (mm) 24 months Posterior face height (mm) 24 months Lower anterior face height (mm) 24 months Overjet (mm) 24 months Nasolabial angle (º) 24 months Maxillary and mandibular arch perimeters (mm) 24 months Maxillary and mandibular incisors position (mm) 24 months Quality of life evaluation with questionnaires 24 months 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.
Discomfort and pain intensity evaluated with questionnaires 24 months 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.
Parent´s perception of children discomfort and pain intensity evaluated with questionnaires 1 month 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.
Trial Locations
- Locations (1)
Bauru Dental School, University of São Paulo
🇧🇷Bauru, São Paulo, Brazil