Bone LossNCT05710497
Maxillary Vascular Canal Thickness and Sinus Augmentation Bleeding
An observational study of Bone Loss, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bone Loss
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 7 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: 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.
- Conditions
- Bone Loss
- Keywords
- Maxillary Sinus Floor Augmentation, Volumetric Computed Tomography, Intra-operative bleeding
- Medical subject headings
- Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of intraoperative bleeding
After surgery, the total amount of intraoperative bleeding will be calculated in milliliters.
Measured: From beginning of surgery to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710497
- Sponsor's protocol ID
- MUDHF_FB_004
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9151634Elian 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.
PubMed 16274154Mardinger 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.
PubMed 17629462Rosano 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.
PubMed 19461336Rosano 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.
PubMed 21143535Solar 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.
PubMed 10196788Stern 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.
PubMed 22117952Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
PubMed 3516738Zijderveld 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.
PubMed 18571027
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Correlation of Maxillary Vascular Canal Thickness With Intraoperative Bleeding During Open Sinus Floor Augmentation: A Volumetric Tomography Study.
- ClinicalTrials.gov ID
- NCT05710497
- Acronym / sponsor ID
- MUDHF_FB_004
- Conditions
- Bone Loss
- Keywords
- Maxillary Sinus Floor Augmentation, Volumetric Computed Tomography, Intra-operative bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 9151634Chanavaz M. Sinus grafting related to implantology. Statistical analysis of 15 years of surgical experience (1979-1994). J Oral Implantol. 1996;22(2):119-30.
- Background: PubMed 16274154Elian 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.
- Background: PubMed 17629462Mardinger 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.
- Background: PubMed 19461336Rosano 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.
- Background: PubMed 21143535Rosano 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.
- Background: PubMed 10196788Solar 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.
- Background: PubMed 22117952Stern 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.
- Background: PubMed 3516738Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
- Background: PubMed 18571027Zijderveld 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Loss, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of intraoperative bleeding (time frame: From beginning of surgery to end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710497, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.