Maxillary Vascular Canal Thickness and Sinus Augmentation Bleeding

November 7, 2023 updated by: Ferit Bayram, Marmara University

Assessing the Correlation of Maxillary Vascular Canal Thickness With Intraoperative Bleeding During Open Sinus Floor Augmentation: A Volumetric Tomography Study.

This study aims to evaluate the relationship between the maxillary intra-osseous vascular canal thickness as measured by volumetric tomography and the amount of intra-operative bleeding during open sinus floor augmentation. A sample of patients will be selected, and their maxillary intra-osseous vascular canal thickness will be measured using volumetric tomography. Intraoperative bleeding will be recorded during open sinus floor augmentation. The data will be analyzed to determine if there is a correlation between the thickness of the maxillary intra-osseous vascular canal and intraoperative bleeding.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

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

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University School of Dentistry

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients who present with the complaint of tooth loss in the posterior region and need rehabilitation with fixed prostheses on implants, whose horizontal bone width is suitable for dental implant placement but sinus floor augmentation will be performed due to insufficient vertical height.

Description

Inclusion Criteria:

  • Maxillary partial or total edentulism, including premolar/molar regions
  • Medically healthy
  • 2 to 5 mm residual bone height
  • Sufficient bone width to place a standard dental implant (diameter >4mm)
  • Age: 18-65 years
  • Patients who volunteered to participate in the study and signed written informed consent

Exclusion Criteria:

  • Maxillary sinusitis
  • Acute myocardial infarction in the last 12 months
  • Use of any medication that may inhibit bone healing
  • History of radiotherapy in the head and neck region
  • Presence of psychiatric problems
  • Smoking more than 10 cigarettes a day
  • Alcoholism
  • Chronic drug use

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of intraoperative bleeding
Time Frame: From beginning of surgery to end of surgery
After surgery, the total amount of intraoperative bleeding will be calculated in milliliters.
From beginning of surgery to end of surgery

Collaborators and Investigators

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

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 7, 2023

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUDHF_FB_004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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