VideoscopeNCT04510701
Videoscope-assisted Lateral Maxillary Sinus Floor Elevation: Evaluation of the Schneiderian Membrane for Micro-tears
An observational study of Videoscope and Maxillary Sinus, run by University of Manitoba at 1 site in Canada.
Trial summary
This case series will recruit patients who require lateral maxillary sinus floor elevation surgery. This procedure will be carried out as per standard surgical protocol. The periodontal resident performing the surgery will evaluate the Schneiderian membrane at several points during the surgery to determine its… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Videoscope, Maxillary Sinus, Schneiderian Membrane
- What is being tested?
- videoscope
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2020to 1 Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of the Dr. Sam Borden Graduate Periodontics Clinic, Dr. Gerald Niznick College of Dentistry, University of Manitoba who require lateral sinus floor elevation surgery.
Who may be able to join
- Patients requiring maxillary sinus floor elevation (lateral approach), with current subantral bone height 6 mm or less
- Male or female patient, 18 years of age and older
- Patients who exhibit adequate ability to comply with postoperative instructions, research protocols and methods
- Patients who have read, understand, and have signed the informed consent form
- Patients with an adequate level of oral hygiene, defined as Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) should be <20% (after periodontal therapy, if necessary)
Who cannot join
- Absolute contraindications:
- Patients on IV bisphosphonates
- Patients who are undergoing chemotherapy
- Patients who have undergone head and neck radiotherapy where the field of irradiation included the maxilla
- Patients whose membrane thickness is increased due to an existing sinus pathology (sinusitis or mucosal cysts): These conditions should be treated prior to surgical treatment (S. W. Kim et al. 2019)
- Diabetic patients with uncontrolled diabetes and poor glycemic control
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- Patients who are undergoing long-term immunosuppressive therapy, or have been taking corticosteroids long-term (Bornstein et al. 2009)
- Patients with active or untreated periodontitis
- Relative contraindications:
- Patients who have been receiving long term oral bisphosphonate therapy (3 years duration or more) (Bornstein et al. 2009)
- Patients who smoke >10 cigarettes per day
- Patients who are alcohol abusers (Li and Wang 2008)
- Patients who are on antithrombotic medications should be treated with extra caution during surgery, as well as patients with blood disorders that may affect hemostasis
Trial locations and contacts
1 site in 1 country.
About this study
This case series will recruit patients who require lateral maxillary sinus floor elevation surgery. This procedure will be carried out as per standard surgical protocol. The periodontal resident performing the surgery will evaluate the Schneiderian membrane at several points during the surgery to determine its integrity (beyond visual inspection). This will be completed by using the videoscope to evaluate the membrane. This evaluation will take place at at least 3 points during the surgery (before membrane elevation, half-way through membrane elevation, and prior to initiating bone grafting procedures). If the resident wishes to evaluate the membrane at other points during the surgery to inspect the integrity of the membrane, this may be accomplished. This evaluation will be recorded for later, further evaluation by experienced periodontists. If no visible perforation is evident, a 1% baby shampoo solution in normal saline (Johnson and Johnson) will be applied topically over the membrane prior to videoscope evaluation. At this point, the patient will lightly blow their nose; if any micro-tears not visible to the naked eye are present, these tears will produce a bubbling effect, which will be recorded by the videoscope. This evaluation will take place with the 1st and 2nd videoscope evaluations (before membrane elevation, and mid-way through elevation).
Patients will be asked to complete a VAS questionnaire at their one-week follow-up appointment in order to determine how post-op healing has been progressing.
After all procedures have been performed, three experienced periodontists will individually evaluate the videos post-surgically. They will evaluate each video and determine if, in their opinion, there is a membrane perforation (yes/no). Each video will be evaluated in a random fashion (each video being evaluated as a separate event, and not by case). The evaluating periodontists will also be masked to the results noted by the surgeon who completed the surgery, and blinded to the patient's information.
- Conditions
- Videoscope, Maxillary Sinus, Schneiderian Membrane
- Being tested
- videoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoscopeOther
a videoscope will be used to evaluate the integrity of the membrane while doing lateral maxillary sinus elevation surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of micro-tears present in the Schneiderian membrane
incidence of micro-tears will be evaluated at 3 points during the surgery
Measured: first evaluation will be done before the membrane is elevated; second will be part-way through elevation of the membrane; and the third evaluation will be once membrane elevation has been completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Nov 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VideoscopeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Ohnander, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510701
- Sponsor's protocol ID
- HS24052 (B2020:072)
- Status last verified
- Jan 2022
- First submitted
- 9 Aug 2020
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videoscope-assisted Lateral Maxillary Sinus Floor Elevation: Evaluation of the Schneiderian Membrane for Micro-tears
- ClinicalTrials.gov ID
- NCT04510701
- Acronym / sponsor ID
- HS24052 (B2020:072)
- Conditions
- Videoscope, Maxillary Sinus, Schneiderian Membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 12 Aug 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.
This case series will recruit patients who require lateral maxillary sinus floor elevation surgery. This procedure will be carried out as per standard surgical protocol. The periodontal resident performing the surgery will evaluate the Schneiderian membrane at several points during the surgery to determine its integrity (beyond visual inspection). This will be completed by using the videoscope to evaluate the membrane. This evaluation will take place at at least 3 points during the surgery (before membrane elevation, half-way through membrane elevation, and prior to initiating bone grafting procedures). If the resident wishes to evaluate the membrane at other points during the surgery to inspect the integrity of the membrane, this may be accomplished. This evaluation will be recorded for later, further evaluation by experienced periodontists. If no visible perforation is evident, a 1% baby shampoo solution in normal saline (Johnson and Johnson) will be applied topically over the membrane prior to videoscope evaluation. At this point, the patient will lightly blow their nose; if any micro-tears not visible to the naked eye are present, these tears will produce a bubbling effect, which will be recorded by the videoscope. This evaluation will take place with the 1st and 2nd videoscope evaluations (before membrane elevation, and mid-way through elevation).
Patients will be asked to complete a VAS questionnaire at their one-week follow-up appointment in order to determine how post-op healing has been progressing.
After all procedures have been performed, three experienced periodontists will individually evaluate the videos post-surgically. They will evaluate each video and determine if, in their opinion, there is a membrane perforation (yes/no). Each video will be evaluated in a random fashion (each video being evaluated as a separate event, and not by case). The evaluating periodontists will also be masked to the results noted by the surgeon who completed the surgery, and blinded to the patient's information.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Dr. Sam Borden Graduate Periodontics Clinic, Dr. Gerald Niznick College of Dentistry, University of Manitoba who require lateral sinus floor elevation surgery.
Key inclusion criteria (5 listed)
- Patients requiring maxillary sinus floor elevation (lateral approach), with current subantral bone height 6 mm or less
- Male or female patient, 18 years of age and older
- Patients who exhibit adequate ability to comply with postoperative instructions, research protocols and methods
- Patients who have read, understand, and have signed the informed consent form
- Patients with an adequate level of oral hygiene, defined as Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) should be <20% (after periodontal therapy, if necessary)
Key exclusion criteria (13 listed)
- Patients on IV bisphosphonates
- Patients who are undergoing chemotherapy
- Patients who have undergone head and neck radiotherapy where the field of irradiation included the maxilla
- Patients whose membrane thickness is increased due to an existing sinus pathology (sinusitis or mucosal cysts): These conditions should be treated prior to surgical treatment (S. W. Kim et al. 2019)
- Diabetic patients with uncontrolled diabetes and poor glycemic control
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 |
|---|---|---|
| videoscopea videoscope will be used to evaluate the integrity of the membrane while doing lateral maxillary sinus elevation surgery | Other | – |
Primary outcome
incidence of micro-tears present in the Schneiderian membrane
Time frame: first evaluation will be done before the membrane is elevated; second will be part-way through elevation of the membrane; and the third evaluation will be once membrane elevation has been completed
incidence of micro-tears will be evaluated at 3 points during the surgery
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 6 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Videoscope and Maxillary Sinus, run by University of Manitoba at 1 site in Canada.
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 5 inclusion and 13 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 6 Jan 2022. 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 Canada. 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?
incidence of micro-tears present in the Schneiderian membrane (time frame: first evaluation will be done before the membrane is elevated; second will be part-way through elevation of the membrane; and the third evaluation will be once membrane elevation has been completed). 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 6 Jan 2022.