Evaluation of Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide Versus Conventional Free Hand Placement Technique in Adult Orthodontic Patients A Split Mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Root proximity
研究概览
简要总结
Although mini screw insertion is considered as a simple and non-invasive technique, it's a critical procedure which requires precision and accuracy. The placement of mini-screw poses a challenge to the orthodontist, particularly if the space available for mini-screws is limited.4 The proximity to the vital structures surrounding the proposed mini-screw position necessitates the precise knowledge of the anatomy of the insertion area.5 The incidence of mini-screw to tooth contact in the placement of inter-radicular region was 27%.6 Although failure of mini screw is considered a multi-factorial concern, many studies reported the proximity of a mini-screw to tooth structures is a major risk factor for failure, especially in the inter-radicular inserted mini-screws. guided insertion was believed to give more favorable results. Above all, the recent technology of the scanning and three-dimensional printing could pave the way to construct a simple accurate guide. Additionally all previous studies assessed the insertion accuracy using CBCT post-operatively, that can't be applied on human subjects for ethical reasons. Thus a non-invasive method for assessment of mini-screw insertion should be implemented.
详细描述
PICOs P: Adult orthodontic patients need mini screws in maxillary arch bilaterally for anchorage I: Three dimensional printed digital guide for mini screw insertion C: Conventional free hand insertion technique
- O: Primary outcome: Root proximity
Secondary outcomes:
- Patient discomfort during insertion 17
- Insertion accuracy
- Angular deviation
- Linear deviation
- Failure 18 S: Split Mouth Randomized clinical Trial
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 (Participant, Outcomes Assessor)
盲法说明
during the insertion procedure the principle investigator and the co supervisor couldn't be blinded, as the two insertion techniques are completely different.
入排标准
- 年龄范围
- 14 Years 至 45 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle
排除标准
- •Mixed dentition patients
- •Smoker patients
- •Patients with Increased lower facial height
- •Patients with missing posterior teeth
- •Bleeding disorders or anticoagulant therapy
- •Patients with cleft lip & palate
- •Patients with facial asymmetry
- •Patients with transverse maxillary deficiency
研究组 & 干预措施
Three dimensional printed digital guide
one mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using Three dimensional printed digital guide, which is a device deisgned and printed through CAD/CAM technology, it's a printed plate fit on the teeth and buccal mucosa with a channel for mini- screw insertion, mini-screw will be inserted through the plate's channel
干预措施: Three dimensional printed digital guide (Device)
Conventional free hand insertion
one mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using conventional free hand insertion of mini-screw, which is a technique using the guiding anatomy for mini-screw insertion using the driver and the operator's skill.
结局指标
主要结局
Root proximity
时间窗: immediately after mini-screw insertion (T0)
Distance between inserted mini screw and the adjacent roots in microns
次要结局
- Patient discomfort:(immediately after mini-screw insertion (T0))
研究者
Hadir Aboshady
Principle investigator
Cairo University
