Maxillary Vascular Canal Thickness and Sinus Augmentation Bleeding

Sponsor
Marmara University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05710497
Collaborator
(none)
20
1
12
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessing the Correlation of Maxillary Vascular Canal Thickness With Intraoperative Bleeding During Open Sinus Floor Augmentation: A Volumetric Tomography Study.
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Total amount of intraoperative bleeding [From beginning of surgery to end of surgery]

      After surgery, the total amount of intraoperative bleeding will be calculated in milliliters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marmara University School of Dentistry Istanbul Turkey 34854

    Sponsors and Collaborators

    • Marmara University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ferit Bayram, Assist. Prof., Marmara University
    ClinicalTrials.gov Identifier:
    NCT05710497
    Other Study ID Numbers:
    • MUDHF_FB_004
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ferit Bayram, Assist. Prof., Marmara University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2023