Biological Anchorage With Selective Micro-osteroperforations (MOPs) in Canine Distalization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Amount of distal movement of the upper canine
研究概览
简要总结
To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the mesio-distal inclination of the canine and the messiah movement of the upper first molar.
Methods: Clinical trial with Split mouth design in 35 orthodontic patients with bilateral extraction of the upper first premolar, each upper canine will be randomly assigned to the intervention (MOP) or to the control side. Participants will be followed for 3 months and the investigators will take periapical radiographs, cast models and clinical measurements before and after canine retraction. The measurements will be taken by previously calibrated operators. The results are going to be determined and compared between sides, with the corresponding statistical tests and the results are going to be analyzed.
详细描述
PICO QUESTION: ¿Does the amount of distal orthodontic movement of the upper canine increase in the side with MOPs compared with the side without MOPs? Population: Orthodontic patients with bilateral extraction of the upper first premolar (Split mouth design trial) Intervention: Distal movement of the upper canine with Selective MOPs (distal to canine) in one hemi-arch Comparison: Distal movement of the upper canine without MOPs in the other hemi-arch Outcome: Canine and first molar movements
GENERAL AIM:
- To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the M-D inclination of the canine and the mesial movement of the upper first molar.
METHODS
OVERVIEW OF DESIGN Study Design: Randomized controlled clinical trial in split mouth design.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Class I or Class II malocclusion, division 1 (ANB: 0º-5º) with maxillary canines completely erupted with the need for canine retraction.
- •Patients in the working phase with MBT prescription, slot 0.022" who have undergone extractions of bilateral upper premolar with more than three months before the time of upper canine distalization and with open space between the canine and the second premolar greater or equal to 3 mm.
- •Age range between 14-40 years.
- •Probing depth less than 4 mm in the upper canine
排除标准
- •Patients with systemic disease.
- •Medicated patients (prolonged use of antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, corticosteroids, systemic steroids, and calcium channel blockers).
- •Pregnancy.
- •Poor oral hygiene evident in more than two visits.
- •Overjet ≥ 6 mm
- •SN-GoGn ≥ 38 °
- •Radiographic evidence of moderate to severe bone loss.
- •Subjects with active periodontal disease
- •Patients who smoke.
- •Individuals with inadequately treated endodontic problems in the study area.
结局指标
主要结局
Amount of distal movement of the upper canine
时间窗: Change from baseline at three months
Distance from a tangent to a reference point in the palate (third palatal ruga) to the distal side of the upper canine (measured in digital models)
Inclination of the upper canine, second premolar and first molar
时间窗: Change from baseline at three months
The angle between the long axis of the clinical crown and the reference plane the occlusal plane.(measured in digital models)
Angulation of the upper canine, second premolar and first molar
时间窗: Change from baseline at three months
The long axis of the posterior buccal surface is going to be measured relative to the occlusal plane (measured in digital models)
Amount of mesial movement of upper first molar
时间窗: Change from baseline at three months
Distance from a tangent to a reference point in the palate (third palatal ruga) to the mesial side of the upper first molar (measured in digital models)
次要结局
- Periodontal status(Change from baseline at three months)
- Evaluation of the perception of pain by the patient: VAS(Change from baseline at three months)
- Number of participants with postoperative inflammation and/or infection(Change from baseline at three months)
- Number of upper canines with external root resorption(Change from baseline at three months)
研究者
Sonia Patricia Plaza
Research coordinator Orthodontic Department
Fundación Universitaria CIEO