Postural Analysis During Dental Surgery

Postural Low Back Pain Clinical Trial

— PAD  

Official title:

Posture Analysis During Dental Surgery Using Visual Markers: a Randomized Controlled Clinical Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637854
• Other study ID #: PAD
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: November 2020
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Demographic data (baseline)

2. Medical and dental history

3. Parameters related to the lower third molar

4. Radiographic tests

5. Marker operator position

6. Pre- and postoperative photographs

Each patients will be recalled for follow-up visits at 7 days. During this session will be carried out the removal of stitches and data will be recorded as follows:

1. VAS pain and trismus.

2. Number of painkillers taken

3. Control photographs

4. Posse Scala

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients elements 38 or 48 in dysodontiasis requiring a complex extraction

• able to sign informed consent

Exclusion Criteria:

• general contraindication to surgical treatment

• pregnancy

• lactation

• age under 18 years

Related Conditions & MeSH terms

• Low Back Pain
• Postural Low Back Pain

Intervention

Procedure:
• Operating microscope
Third molar extraction using microscope
• Surgical loupes
Third molar extraction using loupes with co-axial illumination
• Naked eyes
Third molar extraction using naked eyes

Locations

Country	Name	City	State
Italy	University of Milan	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posture and fatiguing positions	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.	During the surgical procedure (one frame every second during the intervention)
Primary	Rapid Upper Limb Assessment (RULA)	Evaluation tool for ergonomic investigations of workplaces. Values are expressed as RULA scores.	After the operative performance, an average 15 minutes