Postural Low Back PainPADNCT04637854
Postural Analysis During Dental Surgery
A study testing Operating microscope, Surgical loupes and Naked eyes in people with Postural Low Back Pain, run by University of Milan at 1 site in Italy.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postural Low Back Pain
- What is being tested?
- Operating microscope, Surgical loupes and Naked eyes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients elements 38 or 48 in dysodontiasis requiring a complex extraction
- able to sign informed consent
Who cannot join
- general contraindication to surgical treatment
- pregnancy
- lactation
- age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posture Analysis During Dental Surgery Using Visual Markers: a Randomized Controlled Clinical Trial (RCT)
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.
Read the 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
- Conditions
- Postural Low Back Pain
- Being tested
- Operating microscope, Surgical loupes, Naked eyes
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operating microscopeProcedure or surgery
Third molar extraction using microscope
Surgical loupesProcedure or surgery
Third molar extraction using loupes with co-axial illumination
Naked eyesProcedure or surgery
Third molar extraction using naked eyes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Surgical loupes |
| Naked Eye. | Active comparator | The same as above but the intervention will be performed at naked eyes Receives: Procedure: Naked eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After the operative performance, an average 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Mar 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Lodi, University of Milan
- Investigators
- Giovanni Lodi, PhD, DMD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637854
- Sponsor's protocol ID
- PAD
- Acronym
- PAD
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture Analysis During Dental Surgery Using Visual Markers: a Randomized Controlled Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT04637854
- Acronym / sponsor ID
- PAD / PAD
- Conditions
- Postural Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Operating Microscope. | Experimental | Procedure: Operating microscopeSurgical 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. |
| Surgical Loupes with coaxial illumination. | Active comparator | Procedure: Surgical loupesThe same as above but the intervention will be performed with the use of surgical loupes |
| Naked Eye. | Active comparator | Procedure: Naked eyesThe same as above but the intervention will be performed at naked eyes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients elements 38 or 48 in dysodontiasis requiring a complex extraction
- able to sign informed consent
Key exclusion criteria (4 listed)
- general contraindication to surgical treatment
- pregnancy
- lactation
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operating microscopeThird molar extraction using microscope | Procedure or surgery | Operating Microscope. |
| Surgical loupesThird molar extraction using loupes with co-axial illumination | Procedure or surgery | Surgical Loupes with coaxial illumination. |
| Naked eyesThird molar extraction using naked eyes | Procedure or surgery | Naked Eye. |
Primary outcome
Posture and fatiguing positions
Time frame: During the surgical procedure (one frame every second during the intervention)
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)
Time frame: After the operative performance, an average 15 minutes
Evaluation tool for ergonomic investigations of workplaces. Values are expressed as RULA scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Lodi, PhD, DMD principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operating microscope, Surgical loupes and Naked eyes in people with Postural Low Back Pain, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posture and fatiguing positions (time frame: During the surgical procedure (one frame every second during the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.