Impact of COVID-19 on Sinus Augmentation Surgery

July 24, 2023 updated by: Walaa Kadry, Cairo University

The Impact of COVID-19 on the Rate of Peri-operative Complications of Maxillary Sinus Floor Augmentation Procedure.

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 02
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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.
Sinus augmentation in the posterior atrophic maxilla in patients with negative COVID-19 history

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinus membrane perforation
Time Frame: Duration sinus lift
Intraoperative assessment of the incidence of sinus membrane perforation
Duration sinus lift

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Nahla Awadallah, Lecturer at Faculty of Dentistry, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

July 22, 2023

First Submitted That Met QC Criteria

July 22, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • COVID-19 and sinus lift

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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