Posture Analysis During Dental Surgery Using Visual Markers: a Randomized Controlled Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Posture and fatiguing positions
研究概览
简要总结
Background: Attention and awareness towards MSDs in the dental profession has increased considerably in recent years. From recent literature reviews, it is learned that prevalence of MSDs in dentists is 64-93%. It has been seen that the use of magnification systems not only improves the operator's visual capabilities, but also allows for a more correct posture, and to prevent the onset of back and neck disorders.
Purpose and methods: Evaluate dentist posture during extraction of third lower molars depending on whether the operator uses the naked eye, surgical loupes or surgical microscope systems. Data will be evaluated through the index RULA (rapid upper limb assesment) to define whether there is a change in exposure to the risk of MSDs (Muskoloskeletal disease) and using fiducial markers for the movement analysis of the operator during the procedure.
详细描述
Study design: randomized controlled clinical trial. Purpose: Evaluate dentist posture during extraction of third lower molars depending on whether the operator uses the naked eye, surgical loupes or surgical microscope systems. Methods: Data will be analysed through the index RULA (rapid upper limb assesment) to define whether there is a change in exposure to the risk of MSDs (Muskoloskeletal disease).
Posture assessment will be based on 3-D data of the upper body, which can discriminate spatial displacements up to 2mm in translation and 1 degree in rotation.
The surgical intervention will be performed under local anesthesia (mepivacaine 20 mg/ml with adrenaline 1:100000) and by the use of microscope (OPMI Movena S7) or surgical loupes or no magnifying system.
During this session the following data will be collected for the study:
- Demographic data (baseline)
- Medical and dental history
- Parameters related to the lower third molar
- Radiographic tests
- Marker operator position
- Pre- and postoperative photographs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients elements 38 or 48 in dysodontiasis requiring a complex extraction
- •able to sign informed consent
排除标准
- •general contraindication to surgical treatment
- •pregnancy
- •lactation
- •age under 18 years
研究组 & 干预措施
Naked Eye.
The same as above but the intervention will be performed at naked eyes
干预措施: Naked eyes (Procedure)
Operating Microscope.
Surgical technique is the same used for extraction of the lower third molar. Patients will be enrolled (baseline) whenever sign their written informed consent to participate to the study, after having read and understand the informative pamphlet.
The intervention will be performed under local anesthesia (mepivacaine 20 mg/ml with adrenaline 1:100000) and by the use of microscope.
At the end of the surgical procedure, all patients will receive a 100mg Nimesulide cpr and apply the ice pack on the cheek.
At the end of each procedure will give post-operative instructions for all patients and prescribe an antiseptic therapy with chlorhexidine coll. 0.2% 3 times/ day for 10 days from the day following the intervention and anti-inflammatory therapy Nimesulide 100 mg cpr to take up to 2 times / day for up to 4 days.
Each patients will be recalled for follow-up visits at 7 days.
干预措施: Operating microscope (Procedure)
Surgical Loupes with coaxial illumination.
The same as above but the intervention will be performed with the use of surgical loupes
干预措施: Surgical loupes (Procedure)
结局指标
主要结局
Posture and fatiguing positions
时间窗: During the surgical procedure (one frame every second during the intervention)
Specific postural analysis using fiducial markers: a set of markers on the back of a tight T-shirt worn by the dentist during the whole operation will be acquired using a 5 MPixels camera at 2 fps. We will place the markers in order to focus our analysis on the following parameter: the neck position with respect to the trunk, the trunk orientation with respect to the vertical axis, the twist and bending of the neck and back, the overall static position duration of the neck and the back. The rotation angles of every marker will be extracted and stored for every frame of the recorder video.
Rapid Upper Limb Assessment (RULA)
时间窗: After the operative performance, an average 15 minutes
Evaluation tool for ergonomic investigations of workplaces. Values are expressed as RULA scores.
次要结局
未报告次要终点
研究者
Giovanni Lodi
Associate Professor
University of Milan