Clinical trial NCT05710497: Maxillary Vascular Canal Thickness and Sinus Augmentation Bleeding
Official title: Assessing the Correlation of Maxillary Vascular Canal Thickness With Intraoperative Bleeding During Open Sinus Floor Augmentation: A Volumetric Tomography Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Loss
Keywords: Maxillary Sinus Floor Augmentation
Volumetric Computed Tomography
Intra-operative bleeding
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total amount of intraoperative bleeding
timeFrame: From beginning of surgery to end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.
citation: Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
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.