Postural Analysis During Dental Surgery

NCT04637854 | Completed

• 1 other identifier: PAD
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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)

• 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

Study Arms (3)

Operating Microscope.

EXPERIMENTAL

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.

Procedure: Operating microscope

Surgical Loupes with coaxial illumination.

ACTIVE COMPARATOR

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

Procedure: Surgical loupes

Naked Eye.

ACTIVE COMPARATOR

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

Procedure: Naked eyes

Interventions

Operating microscope PROCEDURE

Third molar extraction using microscope

Operating Microscope.

Surgical loupes PROCEDURE

Third molar extraction using loupes with co-axial illumination

Surgical Loupes with coaxial illumination.

Naked eyes PROCEDURE

Third molar extraction using naked eyes

Naked Eye.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients elements 38 or 48 in dysodontiasis requiring a complex extraction
• able to sign informed consent

You may not qualify if:

• general contraindication to surgical treatment
• pregnancy
• lactation
• age under 18 years

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

University of Milan

Milan, 20142, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Lodi, PhD, DMD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 20, 2020
• Study Start: March 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

IT (1)