Status:

COMPLETED

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

Lead Sponsor:

University of Manitoba

Conditions:

Videoscope

Maxillary Sinus

Eligibility:

All Genders

18+ years

Brief 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 perfo...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2022

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT04510701

Start Date

November 1 2020

End Date

January 1 2022

Last Update

January 6 2022

Active Locations (1)

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1

University of Manitoba

Winnipeg, Manitoba, Canada