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

Maxillary Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510701
• Other study ID #: HS24052 (B2020:072)
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

• 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

Related Conditions & MeSH terms

• Maxillary Sinus
• Schneiderian Membrane
• Videoscope

Intervention

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

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of micro-tears present in the Schneiderian membrane	incidence of micro-tears will be evaluated at 3 points during the surgery	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