Apical External Root Resorption Secondary to Orthodontic Forces and Individual Radicular Stress: Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference of volume of the apical portion of the root
研究概览
简要总结
The goal of this prospective clinical trial is to evaluate the possible superiority of a treatment compared to the gold standard of reference in Orthodontics.
详细描述
Apical external root resorption is defined as the loss of dental hard tissues such as dentine, cement and alveolar bone. This is considered an irrevocable effect associated to different factors, among which dental movement during orthodontic treatment is related.
This study suggest to compare root resorption after the use of two different types of alignment and levelling arches in orthodontics. Consecutive patients randomly chosen will be analysed after going through one of the two arches sequences:
- Gold standard group: using arches that provide the same amount of force in all sections . 3M United® nickel-titanium arches (0.012, 0.014, 0.016 x 0.016, 0.020 x 0.020, 0.018 x 0.025 y 0.019 x 0.025)
- Intervention group: using some arches that provide individual sectional forces for each dental group (incisors, premolars and molars). 3M United® nickel-titanium 0.012 and 0.014 arches and BioForce PLUS® arches (0.016 x 0.016, 0.020 x 0.020, 0.018 x 0.025 y 0.019 x 0.025).
All patients will be treated with multi-braces fixed appliances (0.022" technique and VictoryTM brackets).
Root resorption will be compared through CBCT (Cone Beam Computed Tomography) images made before the beginning of treatment (T0), after 8-9 months of the beginning of treatment (T1) and at the end of treatment (T2). Root resorption will be measured by the root volume and surface root morphology in each of the times scheduled.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Population: patients undergoing orthodontic treatment in Orthodontic Department at Dental School of Universidad Complutense de Madrid.
- •Inclusion Criteria:
- •Completed permanent dentition (third molars are excluded)
- •Completed root formation
- •Need of orthodontic treatment
排除标准
- •Tooth agenesis in the anterior region (incisors)
- •Included or ankylosed teeth in the anterior region (incisors)
- •Periodontal pocket >3 mm in any anterior teeth (incisors)
- •Need of a combined surgical and orthodontic treatment
- •Root resorptions observed at the initial CBCT (in more than 3 teeth)
- •Delay of the treatment due to a external reason or complication during treatment
- •Systemic disease or cranio-facial malformation
- •Tooth fracture or restoration in the anterior region (incisors) at the beginning of treatment
- •Problems from roots such as lacerated root, trauma or fractures during treatment 10 Severe occlusal attrition
研究组 & 干预措施
Gold Standard Group
Patients treated with multi-braces fixed appliances and a conventional sequence of aligning and levelling arches (Ni-Ti arches with the same force in all sections)
干预措施: Maxillary and mandibular Cone Beam Computed Tomography record (Procedure)
Intervention Group
Patients treated with multi-braces fixed appliances and a different sequence of aligning and levelling arches (some arches provide individual forces for each group of teeth (incisors, premolars and molars))
干预措施: Maxillary and mandibular Cone Beam Computed Tomography record (Procedure)
结局指标
主要结局
Difference of volume of the apical portion of the root
时间窗: Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2)
Measure of the 5 more apical mm3 of the root at each moment of treatment (T0, T1 and T2)
次要结局
- Root volumen(Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2))
- Root surface area(Baseline/beginning treatment (T0), 34 weeks after beginning treatment (T1) and through treatment completion (T2))