Long-term DBBM Dimensional Changes in Sinus Grafting

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.

Study Overview

• Status: Completed
• Conditions: Deproteinized Bovine Bone Mineral Graft Dimensional Changes

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University - Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent lateral external sinus lift at the Faculty of dentistry at Saint Joseph University of Beirut

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bovine bone mineral graft dimensional changes	To evaluate radiologically using CBCT deproteinized bovine bone mineral graft dimensional changes in region of lateral sinus lift.	12 years

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): April 6, 2026
• Study Completion (Actual): May 20, 2026

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Bone loss, deproteinized bovine bone mineral, computer-assisted image processing, dental implant, sinus floor augmentation, sinus pneumatization.
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: CER 2025-288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No