Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2017-03-01
2018-05-01
Brief Summary
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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
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Operating Microscope.
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.
Operating microscope
Third molar extraction using microscope
Surgical Loupes with coaxial illumination.
The same as above but the intervention will be performed with the use of surgical loupes
Surgical loupes
Third molar extraction using loupes with co-axial illumination
Naked Eye.
The same as above but the intervention will be performed at naked eyes
Naked eyes
Third molar extraction using naked eyes
Interventions
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Operating microscope
Third molar extraction using microscope
Surgical loupes
Third molar extraction using loupes with co-axial illumination
Naked eyes
Third molar extraction using naked eyes
Eligibility Criteria
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Inclusion Criteria
* able to sign informed consent
Exclusion Criteria
* pregnancy
* lactation
* age under 18 years
18 Years
80 Years
ALL
No
Sponsors
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University of Milan
OTHER
Responsible Party
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Giovanni Lodi
Associate Professor
Principal Investigators
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Giovanni Lodi, PhD, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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University of Milan
Milan, , Italy
Countries
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Other Identifiers
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PAD
Identifier Type: -
Identifier Source: org_study_id