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Impact of COVID-19 on Sinus Augmentation Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05960136
Recruitment Status : Completed
First Posted : July 25, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Walaa Kadry, Cairo University

Study Description
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Brief Summary:
The risk of Schneiderian membrane perforation and the postoperative complications of the sinus floor elevation surgery were evaluated for patients with and without history of COVID-19 infection.

Condition or disease Intervention/treatment Phase
Bone Loss Procedure: Sinus lift in patients with positive COVID-19 history Procedure: Sinus lift with negative COVID-19 history Not Applicable

Detailed Description:
COVID-19 induced chronic sinusitis with subsequent increased Schneiderian membrane thickness could increase the risk of its perforation during the sinus floor elevation. The aim of the study is to compare the incidence of Schneiderian membrane perforation and the postoperive complications of the sinus floor elevation in patients with and without history of COVID-19.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of COVID-19 on the Rate of Peri-operative Complications of Maxillary Sinus Floor Augmentation Procedure.
Actual Study Start Date : March 30, 2023
Actual Primary Completion Date : July 15, 2023
Actual Study Completion Date : July 20, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sinus lift in patients with previous COVID-19 infection
Sinus floor augmentation in the posterior atrophic maxilla with delayed implant placement in patients with positive history of previous COVID-19 infection.
 Procedure: Sinus lift in patients with positive COVID-19 history
Sinus augmentation in the posterior atrophic maxilla in patients with positive COVID-19 history
Active Comparator: Sinus lift in patients with negative history of previous COVID
Sinus floor augmentation in the posterior atrophic maxilla with delayed implant placement in patients with negative history of COVID-19 infection.
 Procedure: Sinus lift with negative COVID-19 history
Sinus augmentation in the posterior atrophic maxilla in patients with negative COVID-19 history


Outcome Measures
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Primary Outcome Measures :
  1. Sinus membrane perforation [ Time Frame: Duration sinus lift ]
    Intraoperative assessment of the incidence of sinus membrane perforation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 4 mm or less residual alveolar bone height
  • Age more than 18 years
  • Highly motivated patients

Exclusion Criteria:

  • Patients who suffer from any systemic disease
  • sinus pathosis other than sinusitis induced covid 19
  • Patients under any medication that may interfere with the normal bone healing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05960136


Locations
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Egypt
Faculty of Dentistry, Cairo University
Cairo, Egypt, 02
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Nahla Awadallah Lecturer at Faculty of Dentistry, Cairo University
More Information
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Responsible Party: Walaa Kadry, Lecturer of oral and Maxillofacial Surgery, Cairo University
ClinicalTrials.gov Identifier: NCT05960136    
Other Study ID Numbers: COVID-19 and sinus lift
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No