Deproteinized Bovine Bone Mineral Graft Dimensional ChangesNCT07635472
Long-term DBBM Dimensional Changes in Sinus Grafting
An observational study of Deproteinized Bovine Bone Mineral Graft Dimensional Changes, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
This study aims to evaluate graft volumetric changes and stability up to 12 years after lateral sinus floor elevation with deproteinized bovine bone mineral (DBBM) as a filling material. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deproteinized Bovine Bone Mineral Graft Dimensional Changes
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jun 2025to 20 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent lateral external sinus lift at the Faculty of dentistry at Saint Joseph University of Beirut
Who may be able to join
- Patients who underwent lateral sinus floor elevation with natural bovine bone as filling material after 2011 at the Faculty of Dentistry, Saint Joseph University of Beirut.
- At least 18 years old at baseline
- Systemically healthy
- Patients who sign a new informed consent.
- Smokers (≥ 10 cigarettes/ day) and non-smokers (< 10 cigarettes/ day)
Who cannot join
- Patients who did not take a CBCT within 1 year after the initial surgery.
- Presence of inflammatory lesions at the surgical site (eg, sinusitis as assessed by CBCT).
- History of radiation therapy in the head/neck region.
- Use of bisphosphonates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Volumetric Evaluation of Deproteinized Bovine Bone Mineral Graft Dimensional Changes After Lateral Window Sinus Floor Elevation: a Long-term Retrospective Study up to 12 Years.
This study aims to evaluate graft volumetric changes and stability up to 12 years after lateral sinus floor elevation with deproteinized bovine bone mineral (DBBM) as a filling material.
Read the detailed description
This study aims to assess graft volume changes and stability up to 12 years after lateral sinus floor elevation using natural bovine bone. The research will involve patients who underwent external sinus lifts starting 2011 and had pre-operative and post-operative CBCT scans. The study will include a retrospective comparison of graft volume changes using three time points: T0 (pre-operative CBCT, showing residual bone height), T1 (post-operative CBCT acquired at different time points, including immediately after the procedure T' and 9-months post-operative scans T''), and T2 (long-term post-operative CBCT). The residual bone height from T0 will be excluded in subsequent scans to focus on evaluating changes in graft volume.
For the primary outcome evaluate radiographically in 3D using CBCT volumetric changes in region of lateral sinus lift using deproteinized bovine bone graft material.
For the secondary outcome is to evaluate potential differences in graft volumetric changes among different age groups, genders, smoking vs. non-smoking patients and to evaluate implant survival. In addition to that, to detect a potential pattern in graft resorption/ stabilization for only 11 patients from Ghosn et al's study (with immediate post-operative CBCT and 9 months post-operative CBCT).
For this, a minimum sample size of 52 patients (increasing the sample size as much as possible > 60 for more accurate results) are needed for statistical analysis to detect a significant difference in graft volume and an additional 11 patients are needed from Ghosn's et al study for an additional analysis (exploratory purpose).
Patient's inclusion criteria include:
- Lateral sinus floor elevation using deproteinized bovine bone graft after 2011 at the faculty of dentistry.
- At least 18 years old at baseline.
- Systemically healthy.
- Signing a new informed consent.
- Smokers (≥ 10 cigarettes/ day) and non-smokers ( < 10 cigarettes/ day)
Patient's exclusion criteria include:
- No CBCT taken within 1 year after surgery.
- Inflammatory lesions present near surgical site.
- History of radiation therapy in head/ neck region.
- Use of bisphosphonates. CBCT comparisons will be done using 3D Slicer starting with CBCT superimposition for the different CBCTs at different time points for initial alignment followed by automatic alignment by best fit matching (for re-approximation with minimal deviation) and exclusion of the mobile mandible. Then, bone graft segmentation and volume calculation will be done by excluding the RBH to detect the exact bone graft volume from pre-implant placement followed by long-term follow-up.
This will be followed by statistical analysis for the analysis of the collected results and manuscript writing for the conclusions drawn.
- Keywords
- Bone loss, deproteinized bovine bone mineral, computer-assisted image processing, dental implant, sinus floor augmentation, sinus pneumatization.
- Medical subject headings
- Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
bovine bone mineral graft dimensional changes
To evaluate radiologically using CBCT deproteinized bovine bone mineral graft dimensional changes in region of lateral sinus lift.
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2025
- Primary completion6 Apr 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deproteinized Bovine Bone Mineral Graft Dimensional ChangesStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635472
- Sponsor's protocol ID
- CER 2025-288
- Status last verified
- Jun 2026
- First submitted
- 24 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. Post-extraction dimensional changes: A systematic review and meta-analysis. 2. Pjetursson BE, Heimisdottir K. Dental implants - are they better than natural teeth? Eur J Oral Sci. 2018 Oct;126(S1):81-7. 3. Menassa G, Kassir AR, Landi L, Naaman NBA, Chakar C. Implant placement with sinus floor elevation via the lateral approach using only absorbable collagen sponge: 12-month post-loading radiographical outcomes and implant survival rate. Oral Maxillofac Surg. 2021 Jun;25(2):231-6. 4. Danesh-Sani SA, Engebretson SP, Janal MN. Histomorphometric results of different grafting materials and effect of healing time on bone maturation after sinus floor augmentation: a systematic review and meta-analysis. J Periodontal Res. 2017 Jun;52(3):301-12. 5. Tatum H. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. 6. Wiltfang J, Schultze-Mosgau S, Nkenke E, Thorwarth M, Neukam FW, Schlegel KA. Onlay augmentation versus sinuslift procedure in the treatment of the severely resorbed maxilla: a 5-year comparative longitudinal study. Int J Oral Maxillofac Surg. 2005 Dec;34(8):885-9. 7. Binger T, Hell B. Resorption of microsurgically vascularized bone grafts after augmentation of the mandible. J Cranio-Maxillo-fac Surg Off Publ Eur Assoc Cranio-Maxillo-fac Surg. 1999 Apr;27(2):82-5. 8. Jensen OT, Shulman LB, Block MS, Iacono VJ. Report of the Sinus Consensus Conference of 1996. Int J Oral Maxillofac Implants. 1998;13 Suppl:11-45. 9. Stern A, Green J. Sinus Lift Procedures: An Overview of Current Techniques. Dent Clin North Am. 2012 Jan;56(1):219-33. 10. Zijderveld SA, Schulten EAJM, Aartman IHA, ten Bruggenkate CM. Long-term changes in graft height after maxillary sinus floor elevation with different grafting materials: radiographic evaluation with a minimum follow-up of 4.5 years. Clin Oral Implants Res. 2009 Jul;20(7):691-700. 11. Schmitt C, Karasholi T, Lutz R, Wiltfang J
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Volumetric Evaluation of Deproteinized Bovine Bone Mineral Graft Dimensional Changes After Lateral Window Sinus Floor Elevation: a Long-term Retrospective Study up to 12 Years.
- ClinicalTrials.gov ID
- NCT07635472
- Acronym / sponsor ID
- CER 2025-288
- Keywords
- Bone loss, deproteinized bovine bone mineral, computer-assisted image processing, dental implant, sinus floor augmentation, sinus pneumatization.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 9 Jun 2026 (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 graft volumetric changes and stability up to 12 years after lateral sinus floor elevation with deproteinized bovine bone mineral (DBBM) as a filling material.
Detailed description
This study aims to assess graft volume changes and stability up to 12 years after lateral sinus floor elevation using natural bovine bone. The research will involve patients who underwent external sinus lifts starting 2011 and had pre-operative and post-operative CBCT scans. The study will include a retrospective comparison of graft volume changes using three time points: T0 (pre-operative CBCT, showing residual bone height), T1 (post-operative CBCT acquired at different time points, including immediately after the procedure T' and 9-months post-operative scans T''), and T2 (long-term post-operative CBCT). The residual bone height from T0 will be excluded in subsequent scans to focus on evaluating changes in graft volume.
For the primary outcome evaluate radiographically in 3D using CBCT volumetric changes in region of lateral sinus lift using deproteinized bovine bone graft material.
For the secondary outcome is to evaluate potential differences in graft volumetric changes among different age groups, genders, smoking vs. non-smoking patients and to evaluate implant survival. In addition to that, to detect a potential pattern in graft resorption/ stabilization for only 11 patients from Ghosn et al's study (with immediate post-operative CBCT and 9 months post-operative CBCT).
For this, a minimum sample size of 52 patients (increasing the sample size as much as possible > 60 for more accurate results) are needed for statistical analysis to detect a significant difference in graft volume and an additional 11 patients are needed from Ghosn's et al study for an additional analysis (exploratory purpose).
Patient's inclusion criteria include:
- Lateral sinus floor elevation using deproteinized bovine bone graft after 2011 at the faculty of dentistry.
- At least 18 years old at baseline.
- Systemically healthy.
- Signing a new informed consent.
- Smokers (≥ 10 cigarettes/ day) and non-smokers ( < 10 cigarettes/ day)
Patient's exclusion criteria include:
- No CBCT taken within 1 year after surgery.
- Inflammatory lesions present near surgical site.
- History of radiation therapy in head/ neck region.
- Use of bisphosphonates. CBCT comparisons will be done using 3D Slicer starting with CBCT superimposition for the different CBCTs at different time points for initial alignment followed by automatic alignment by best fit matching (for re-approximation with minimal deviation) and exclusion of the mobile mandible. Then, bone graft segmentation and volume calculation will be done by excluding the RBH to detect the exact bone graft volume from pre-implant placement followed by long-term follow-up.
This will be followed by statistical analysis for the analysis of the collected results and manuscript writing for the conclusions drawn.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent lateral external sinus lift at the Faculty of dentistry at Saint Joseph University of Beirut
Key inclusion criteria (5 listed)
- Patients who underwent lateral sinus floor elevation with natural bovine bone as filling material after 2011 at the Faculty of Dentistry, Saint Joseph University of Beirut.
- At least 18 years old at baseline
- Systemically healthy
- Patients who sign a new informed consent.
- Smokers (≥ 10 cigarettes/ day) and non-smokers (< 10 cigarettes/ day)
Key exclusion criteria (4 listed)
- Patients who did not take a CBCT within 1 year after the initial surgery.
- Presence of inflammatory lesions at the surgical site (eg, sinusitis as assessed by CBCT).
- History of radiation therapy in the head/neck region.
- Use of bisphosphonates.
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
bovine bone mineral graft dimensional changes
Time frame: 12 years
To evaluate radiologically using CBCT deproteinized bovine bone mineral graft dimensional changes in region of lateral sinus lift.
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 9 Jun 2026.
- Background1. Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. Post-extraction dimensional changes: A systematic review and meta-analysis. 2. Pjetursson BE, Heimisdottir K. Dental implants - are they better than natural teeth? Eur J Oral Sci. 2018 Oct;126(S1):81-7. 3. Menassa G, Kassir AR, Landi L, Naaman NBA, Chakar C. Implant placement with sinus floor elevation via the lateral approach using only absorbable collagen sponge: 12-month post-loading radiographical outcomes and implant survival rate. Oral Maxillofac Surg. 2021 Jun;25(2):231-6. 4. Danesh-Sani SA, Engebretson SP, Janal MN. Histomorphometric results of different grafting materials and effect of healing time on bone maturation after sinus floor augmentation: a systematic review and meta-analysis. J Periodontal Res. 2017 Jun;52(3):301-12. 5. Tatum H. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. 6. Wiltfang J, Schultze-Mosgau S, Nkenke E, Thorwarth M, Neukam FW, Schlegel KA. Onlay augmentation versus sinuslift procedure in the treatment of the severely resorbed maxilla: a 5-year comparative longitudinal study. Int J Oral Maxillofac Surg. 2005 Dec;34(8):885-9. 7. Binger T, Hell B. Resorption of microsurgically vascularized bone grafts after augmentation of the mandible. J Cranio-Maxillo-fac Surg Off Publ Eur Assoc Cranio-Maxillo-fac Surg. 1999 Apr;27(2):82-5. 8. Jensen OT, Shulman LB, Block MS, Iacono VJ. Report of the Sinus Consensus Conference of 1996. Int J Oral Maxillofac Implants. 1998;13 Suppl:11-45. 9. Stern A, Green J. Sinus Lift Procedures: An Overview of Current Techniques. Dent Clin North Am. 2012 Jan;56(1):219-33. 10. Zijderveld SA, Schulten EAJM, Aartman IHA, ten Bruggenkate CM. Long-term changes in graft height after maxillary sinus floor elevation with different grafting materials: radiographic evaluation with a minimum follow-up of 4.5 years. Clin Oral Implants Res. 2009 Jul;20(7):691-700. 11. Schmitt C, Karasholi T, Lutz R, Wiltfang J
- Individual participant dataSharing planned: No
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 Deproteinized Bovine Bone Mineral Graft Dimensional Changes, run by Saint-Joseph University at 1 site in Lebanon.
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 5 inclusion and 4 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 9 Jun 2026. 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 Lebanon. 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?
bovine bone mineral graft dimensional changes (time frame: 12 years). 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 NCT07635472, which also lists 1 linked publication.
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 9 Jun 2026.