Videoscope-assisted Lateral Maxillary Sinus Floor Elevation: Evaluation of

Status Completed

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04510701
Study type	Observational
Source	University of Manitoba
Contact
Status	Completed
Phase
Start date	November 1, 2020
Completion date	January 1, 2022

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Videoscope-assisted Lateral Maxillary Sinus Floor Elevation: Evaluation of the Schneiderian Membrane for Micro-tears

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms