Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of orthodontic tooth movement
研究概览
简要总结
The purpose of this investigation is intended to evaluate the efficacy of surgically facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root shortening, and occurrence of mucogingival side effects compared to conventional orthodontic therapy in patients undergoing orthodontic treatment to correct crowding and/or retroclination of their mandibular anterior dentition.
详细描述
The null-hypothesis for this research project is that there will be no difference in the rate of orthodontic movement among patients requiring proclination or alignment of their mandibular anterior teeth with SFO (TEST group) as compared to conventional orthodontic treatment (CONTROL group). A null-hypothesis is that there will be no difference between both treatment groups in the occurrence of dental (root shortening) or periodontal (mucogingival defects, alveolar bone resorption) complications associated with orthodontic treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth.
排除标准
- •Bone-related diseases
- •Previous or current use of biphosphate therapy
- •Previous mucogingival surgery in the area
- •Genetic syndromes, craniofacial anomalies, or cleft lip and/or palate
- •History of previous orthodontic treatment less than 4 years ago
- •Smoking >10 cigarettes/day )
- •Medical history that contraindicates surgical treatment,
- •People who are not cognitively able to give consent,
- •Pregnancy
研究组 & 干预措施
Conventional orthodontic treatment
conventional orthodontic treatment in the mandibular anterior region
干预措施: Conventional orthodontic treatment (Procedure)
Surgically facilitated Orthodontics
Surgically facilitated Orthodontic treatment in the mandibular anterior region
干预措施: Surgically facilitated Orthodontic treatment (Procedure)
结局指标
主要结局
Rate of orthodontic tooth movement
时间窗: 6 months(plus or minus 1 week)
Difference between the rate of orthodontic tooth movement between the two groups as measured by linear measurements on digitized study casts obtained at 4-week intervals.
次要结局
- Incidence of mucogingival defects(6 months(plus or minus 2weeks) after initiation of treatment)
- Incidence and magnitude of apical root resorption(6(plus or minus 1) months following initiation of treatment)