Radiographic Assessment of Deproteinized Porcine Versus Bovine Bone Mineral in Sinus Augmentation
NCT ID: NCT07182929
Last Updated: 2025-09-24
Study Results
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Basic Information
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COMPLETED
56 participants
OBSERVATIONAL
2024-01-01
2025-07-01
Brief Summary
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Does DPBM show greater graft resorption than DBBM at 6 months postoperatively? Do both materials achieve comparable bone quality and osseointegration outcomes despite differences in resorption rates?
This is a retrospective, single-center cohort study. Participants included 56 patients (56 sinuses) who underwent LSFA with either DPBM (test group, n=28) or DBBM (control group, n=28) and had complete cone-beam CT scans taken preoperatively, immediately postoperatively, and at 6 months post-surgery. Radiographic parameters such as bone height, augmentation volume, and bone texture features were analyzed to evaluate graft stability and new bone formation.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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DBBM
Patients in DBBM group receive 0.5g of DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG Co., Ltd, Wolhusen, Switzerland) during the sinus augmentation
Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral
Lateral Sinus Floor Augmentation Using Deproteinized Porcine Bone Mineral (DPBM, test) with Simultaneous Implant Placement and 6-Month CBCT Follow-Up
DPBM
Patients in DBBM group receive 0.5g of DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG Co., Ltd, Wolhusen, Switzerland) during the sinus augmentation
No interventions assigned to this group
Interventions
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Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral
Lateral Sinus Floor Augmentation Using Deproteinized Porcine Bone Mineral (DPBM, test) with Simultaneous Implant Placement and 6-Month CBCT Follow-Up
Eligibility Criteria
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Inclusion Criteria
2. Single or multiple missing teeth in the posterior maxilla with a healing period of at least 3 months;
3. Complete baseline data and surgical records;
4. Underwent LSFA with simultaneous placement of a single implant, grafted exclusively with either DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG, Wolhusen, Switzerland) or DPBM (THE Graft®, 0.25-1.0 mm, Purgo Biologics, Seoul, Korea);
5. Available CBCT images obtained preoperatively (T0), immediately postoperatively (T1), and at 6 months postoperatively (T2);
6. RBH ≤6 mm shown by CBCT at T0 at the edentulous site;
7. No systemic disease, untreated periapical pathology or active periodontitis;
8. Provision of written informed consent for the implant surgery by the patient or their legal guardian.
Exclusion Criteria
2. Pregnancy or lactation;
3. Head and neck radiation therapy within the past 5 years;
4. acute and chronic inflammation in the maxillary sinus;
5. Additional vertical or horizontal bone augmentation procedures besides LSFA;
6. Use of graft materials other than the specified DBBM or DPBM, or use of composite grafts;
7. Heavy smoking (≥20 cigarettes/day), alcohol abuse, or history of substance abuse;
8. Placement of multiple implants in the same grafted site (excluded to avoid within-patient confounding).
18 Years
80 Years
ALL
No
Sponsors
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The Dental Hospital of Zhejiang University School of Medicine
OTHER
National Natural Science Foundation of China
OTHER_GOV
Guoli Yang
OTHER
Responsible Party
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Guoli Yang
Professor
Locations
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The Affiliated Hospital, School of Stomatology, Zhejiang University., Hangzhou, Zhejiang 310000
Hangzhou, Zhejiang, China
Countries
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References
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Krennmair S, Postl L, Schwarze UY, Malek M, Stimmelmayr M, Krennmair G. Clinical, radiographic, and histological/histomorphometric analysis of maxillary sinus grafting with deproteinized porcine or bovine bone mineral: A randomized clinical trial. Clin Oral Implants Res. 2023 Nov;34(11):1230-1247. doi: 10.1111/clr.14164. Epub 2023 Aug 23.
Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.
Lee JS, Shin HK, Yun JH, Cho KS. Randomized Clinical Trial of Maxillary Sinus Grafting using Deproteinized Porcine and Bovine Bone Mineral. Clin Implant Dent Relat Res. 2017 Feb;19(1):140-150. doi: 10.1111/cid.12430. Epub 2016 Jun 21.
Cassetta M, Perrotti V, Calasso S, Piattelli A, Sinjari B, Iezzi G. Bone formation in sinus augmentation procedures using autologous bone, porcine bone, and a 50 : 50 mixture: a human clinical and histological evaluation at 2 months. Clin Oral Implants Res. 2015 Oct;26(10):1180-4. doi: 10.1111/clr.12423. Epub 2014 May 26.
Pagliani L, Andersson P, Lanza M, Nappo A, Verrocchi D, Volpe S, Sennerby L. A collagenated porcine bone substitute for augmentation at Neoss implant sites: a prospective 1-year multicenter case series study with histology. Clin Implant Dent Relat Res. 2012 Oct;14(5):746-58. doi: 10.1111/j.1708-8208.2010.00314.x. Epub 2010 Oct 26.
Barone A, Ricci M, Covani U, Nannmark U, Azarmehr I, Calvo-Guirado JL. Maxillary sinus augmentation using prehydrated corticocancellous porcine bone: hystomorphometric evaluation after 6 months. Clin Implant Dent Relat Res. 2012 Jun;14(3):373-9. doi: 10.1111/j.1708-8208.2010.00274.x. Epub 2010 May 11.
Iezzi G, Degidi M, Piattelli A, Mangano C, Scarano A, Shibli JA, Perrotti V. Comparative histological results of different biomaterials used in sinus augmentation procedures: a human study at 6 months. Clin Oral Implants Res. 2012 Dec;23(12):1369-76. doi: 10.1111/j.1600-0501.2011.02308.x. Epub 2011 Nov 2.
Scarano A, Piattelli A, Perrotti V, Manzon L, Iezzi G. Maxillary sinus augmentation in humans using cortical porcine bone: a histological and histomorphometrical evaluation after 4 and 6 months. Clin Implant Dent Relat Res. 2011 Mar;13(1):13-8. doi: 10.1111/j.1708-8208.2009.00176.x.
Orsini G, Scarano A, Piattelli M, Piccirilli M, Caputi S, Piattelli A. Histologic and ultrastructural analysis of regenerated bone in maxillary sinus augmentation using a porcine bone-derived biomaterial. J Periodontol. 2006 Dec;77(12):1984-90. doi: 10.1902/jop.2006.060181.
Other Identifiers
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81901051, 82370991, 2022KY872
Identifier Type: OTHER
Identifier Source: secondary_id
2024-153(R)
Identifier Type: -
Identifier Source: org_study_id
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