Postural Analysis During Dental Surgery (PAD)

University of Milan

Status: Completed

Conditions: Postural Low Back Pain

Treatments: Procedure: Operating microscope; Procedure: Naked eyes; Procedure: Surgical loupes

Study type: Interventional

Funder types: Other

Identifiers

NCT04637854

PAD

Details and patient eligibility

About

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.

Full 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

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Operating Microscope.

Experimental group

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.

Treatment:

Procedure: Operating microscope

Surgical Loupes with coaxial illumination.

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical loupes

Naked Eye.

Active Comparator group

Description:

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

Treatment:

Procedure: Naked eyes