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Postural Analysis During Dental Surgery (PAD)

Primary Purpose

Postural Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Operating microscope
Surgical loupes
Naked eyes
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postural Low Back Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Milan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Operating Microscope.

Surgical Loupes with coaxial illumination.

Naked Eye.

Arm Description

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.

The same as above but the intervention will be performed with the use of surgical loupes

The same as above but the intervention will be performed at naked eyes

Outcomes

Primary Outcome Measures

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.
Rapid Upper Limb Assessment (RULA)
Evaluation tool for ergonomic investigations of workplaces. Values are expressed as RULA scores.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2020
Last Updated
November 19, 2020
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT04637854
Brief Title
Postural Analysis During Dental Surgery
Acronym
PAD
Official Title
Posture Analysis During Dental Surgery Using Visual Markers: a Randomized Controlled Clinical Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Low Back Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Operating Microscope.
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgical Loupes with coaxial illumination.
Arm Type
Active Comparator
Arm Description
The same as above but the intervention will be performed with the use of surgical loupes
Arm Title
Naked Eye.
Arm Type
Active Comparator
Arm Description
The same as above but the intervention will be performed at naked eyes
Intervention Type
Procedure
Intervention Name(s)
Operating microscope
Intervention Description
Third molar extraction using microscope
Intervention Type
Procedure
Intervention Name(s)
Surgical loupes
Intervention Description
Third molar extraction using loupes with co-axial illumination
Intervention Type
Procedure
Intervention Name(s)
Naked eyes
Intervention Description
Third molar extraction using naked eyes
Primary Outcome Measure Information:
Title
Posture and fatiguing positions
Description
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.
Time Frame
During the surgical procedure (one frame every second during the intervention)
Title
Rapid Upper Limb Assessment (RULA)
Description
Evaluation tool for ergonomic investigations of workplaces. Values are expressed as RULA scores.
Time Frame
After the operative performance, an average 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Lodi, PhD, DMD
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Milan
City
Milan
ZIP/Postal Code
20142
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Postural Analysis During Dental Surgery

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