Clinical trial NCT04637854: Postural Analysis During Dental Surgery
Official title: Posture Analysis During Dental Surgery Using Visual Markers: a Randomized Controlled Clinical Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Low Back Pain
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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

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

Primary outcomes:
measure: Posture and fatiguing positions
timeFrame: During the surgical procedure (one frame every second during the intervention)
measure: Rapid Upper Limb Assessment (RULA)
timeFrame: After the operative performance, an average 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Milan
Study officials:
affiliation: University of Milan
name: Giovanni Lodi, PhD, DMD
role: PRINCIPAL_INVESTIGATOR
References: