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

NCT04510701 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2022-01-06

No results posted yet for this study

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.

Conditions

  • Videoscope
  • Maxillary Sinus
  • Schneiderian Membrane

Interventions

OTHER

videoscope

a videoscope will be used to evaluate the integrity of the membrane while doing lateral maxillary sinus elevation surgery

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04510701 on ClinicalTrials.gov