- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05960136
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
Status
Completed
Conditions
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.
Sponsor
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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