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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05710497
Other study ID # MUDHF_FB_004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date November 7, 2023

Study information

Verified date November 2023
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 7, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Marmara University School of Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Chanavaz M. Sinus grafting related to implantology. Statistical analysis of 15 years of surgical experience (1979-1994). J Oral Implantol. 1996;22(2):119-30. — View Citation

Elian N, Wallace S, Cho SC, Jalbout ZN, Froum S. Distribution of the maxillary artery as it relates to sinus floor augmentation. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):784-7. — View Citation

Mardinger O, Abba M, Hirshberg A, Schwartz-Arad D. Prevalence, diameter and course of the maxillary intraosseous vascular canal with relation to sinus augmentation procedure: a radiographic study. Int J Oral Maxillofac Surg. 2007 Aug;36(8):735-8. doi: 10.1016/j.ijom.2007.05.005. Epub 2007 Jul 12. — View Citation

Rosano G, Taschieri S, Gaudy JF, Del Fabbro M. Maxillary sinus vascularization: a cadaveric study. J Craniofac Surg. 2009 May;20(3):940-3. doi: 10.1097/SCS.0b013e3181a2d77f. — View Citation

Rosano G, Taschieri S, Gaudy JF, Weinstein T, Del Fabbro M. Maxillary sinus vascular anatomy and its relation to sinus lift surgery. Clin Oral Implants Res. 2011 Jul;22(7):711-715. doi: 10.1111/j.1600-0501.2010.02045.x. Epub 2010 Dec 9. — View Citation

Solar P, Geyerhofer U, Traxler H, Windisch A, Ulm C, Watzek G. Blood supply to the maxillary sinus relevant to sinus floor elevation procedures. Clin Oral Implants Res. 1999 Feb;10(1):34-44. doi: 10.1034/j.1600-0501.1999.100105.x. — View Citation

Stern A, Green J. Sinus lift procedures: an overview of current techniques. Dent Clin North Am. 2012 Jan;56(1):219-33, x. doi: 10.1016/j.cden.2011.09.003. — View Citation

Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. — View Citation

Zijderveld SA, van den Bergh JP, Schulten EA, ten Bruggenkate CM. Anatomical and surgical findings and complications in 100 consecutive maxillary sinus floor elevation procedures. J Oral Maxillofac Surg. 2008 Jul;66(7):1426-38. doi: 10.1016/j.joms.2008.01.027. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total amount of intraoperative bleeding After surgery, the total amount of intraoperative bleeding will be calculated in milliliters. From beginning of surgery to end of surgery
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