Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gonial angle (º)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •previous orthodontic treatment,
- •craniofacial anomalies or syndromes,
- •tooth agenesis,
- •loss of permanent teeth,
- •severe crowding,
- •maxillary constriction or posterior crossbite
研究组 & 干预措施
Bonded Spurs associated with posterior build-ups Group
The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.
干预措施: Bonded Spurs associated with posterior build-ups (Device)
Conventional bonded spurs Group
Active comparator group will consist of 25 patients treated with conventional bonded spurs
干预措施: Conventional bonded spurs (Device)
结局指标
主要结局
Gonial angle (º)
时间窗: 12 months
Overbite (mm)
时间窗: 12 months
Mandibular plane angle (º)
时间窗: 12 months
Maxillary and mandibular molar vertical development (mm)
时间窗: 12 months
次要结局
- Maxillary and mandibular length (mm)(24 months)
- Maxillary and mandibular incisors position (mm)(24 months)
- 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)
- 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)
- Quality of life evaluation with questionnaires(24 months)
- Discomfort and pain intensity evaluated with questionnaires(24 months)
- Parent´s perception of children discomfort and pain intensity evaluated with questionnaires(1 month)
- Lower anterior face height (mm)(12 months)
- Overjet (mm)(12 months)
- Maxillary and mandibular incisors Inclination (º)(12 months)
- Maxillary and mandibular incisors position (mm)(12 months)
- Maxillary and mandibular incisors height (mm)(12 months)
- Nasolabial angle (º)(12 months)
- Upper lip inclination (º)(12 months)
- Upper and lower lip position (mm)(12 months)
- Interlabial gap (mm)(12 months)
- Maxillary and mandibular anterior dentoalveolar vertical development (mm)(12 months)
- Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)(12 months)
- Maxillary and mandibular inter-first permanent molar distances (mm)(12 months)
- Maxillary and mandibular inter-canine distances (mm)(12 months)
- Maxillary and mandibular arch perimeters (mm)(12 months)
- Maxillary and mandibular arch lengths (mm)(12 months)
- Palatal depth (mm)(12 months)
- Dentoalveolar displacements obtained from three-dimensional superimposition (mm)(12 months)
- Sagittal skeletal discrepancy (º)(12 months)
- Facial axis angle (º)(12 months)
- Maxillomandibular divergence angle (º)(12 months)
- Palatal plane inclination (º)(12 months)
- Anterior face height (mm)(12 months)
- Posterior face height (mm)(12 months)
- Maxillary and mandibular position (º)(12 months)
- Maxillary and mandibular length (mm)(12 months)
- Mandibular ramus height (mm)(12 months)
- Discomfort and pain intensity evaluated with questionnaires(1 month)
- Discomfort and pain intensity evaluated with questionnaires(12 months)
- Quality of life evaluation with questionnaires(12 months)
研究者
Aron Aliaga-Del Castillo
DDS, MSc., PhD Student
University of Sao Paulo