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Completed

NCT Number: NCT04637854

Postural Analysis During Dental Surgery

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.

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Key information

Conditions

Postural Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Milan

Milan, 20142, Italy

About this study

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

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:

  • VAS pain and trismus.
  • Number of painkillers taken
  • Control photographs
  • Posse Scala

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operating microscope

Procedure

Third molar extraction using microscope

Surgical loupes

Procedure

Third molar extraction using loupes with co-axial illumination

Naked eyes

Procedure

Third molar extraction using naked eyes

Primary outcomes

  1. Posture and fatiguing positions

    Time frame: 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.

  2. Rapid Upper Limb Assessment (RULA)

    Time frame: After the operative performance, an average 15 minutes

    Evaluation tool for ergonomic investigations of workplaces. Values are expressed as RULA scores.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Acronym: PAD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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