Radiographic Assessment of Deproteinized Porcine Versus Bovine Bone Mineral in Sinus Augmentation

NCT07182929 | Completed

• 2 other identifiers: 2024-153(R)81901051, 82370991, 2022KY872
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective study is to compare the radiographic outcomes of deproteinized porcine bone mineral (DPBM) and deproteinized bovine bone mineral (DBBM) following lateral sinus floor augmentation (LSFA) with simultaneous implant placement. The main questions it aims to answer are: 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.

Conditions

Sinus Floor Elevation; Sinus Floor Augmentation

Keywords

clinical research; Sinus Floor Augmentation; Cone-beam computed tomography; Bone Substitutes; Dental Implants

Outcome Measures

Primary Outcomes (4)

• Apical Bone Height (ABH)

  The vertical distance (mm) from the implant apex to the most apical point of the graft material

  immediately postoperatively (T1), and 6 months postoperatively (T2)

• Bone Height (BH)

  The vertical distance (mm) from the implant shoulder to the most apical point of the graft material. Site-specific measurements were denoted as buccal (bBH), palatal (pBH), mesial (mBH), and distal (dBH) bone heights

  immediately postoperatively (T1), and 6 months postoperatively (T2)

• Endo-Sinus Bone Gain (ESBG)

  The vertical distance of the augmented bone along the longitudinal axis of the implant, from the sinus floor to the most apical point of the graft

  immediately postoperatively (T1), and 6 months postoperatively (T2)

• augmented volume (AV, mm³)

  The augmented volume (AV, mm³) was measured at both T1 and T2 and was analyzed with the segmentation function of 3D Slicer 5.8.1

  immediately postoperatively (T1), and 6 months postoperatively (T2)

Secondary Outcomes (1)

• Peri-Implant Bone Level (PBL)

  immediately postoperatively (T1), and 6 months postoperatively (T2)

Study Arms (2)

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

Procedure: Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral

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

Interventions

Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral PROCEDURE

Lateral Sinus Floor Augmentation Using Deproteinized Porcine Bone Mineral (DPBM, test) with Simultaneous Implant Placement and 6-Month CBCT Follow-Up

DBBM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received LSFA with simultaneous implant placement from June 2022 to June 2024 at the Stomatology Hospital, Zhejiang University School of Medicine, were screened for eligibility. All patients underwent preoperative clinical, radiographic examinations and laboratory tests. Eligible patients subsequently received LSFA performed by experienced implant surgeons following the standardized surgical protocol.

You may qualify if:

• Aged between 18 and 80 years;
• Single or multiple missing teeth in the posterior maxilla with a healing period of at least 3 months;
• Complete baseline data and surgical records;
• 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);
• Available CBCT images obtained preoperatively (T0), immediately postoperatively (T1), and at 6 months postoperatively (T2);
• RBH ≤6 mm shown by CBCT at T0 at the edentulous site;
• No systemic disease, untreated periapical pathology or active periodontitis;
• Provision of written informed consent for the implant surgery by the patient or their legal guardian.

You may not qualify if:

• Uncontrolled systemic diseases or any bone-metabolism diseases;
• Pregnancy or lactation;
• Head and neck radiation therapy within the past 5 years;
• acute and chronic inflammation in the maxillary sinus;
• Additional vertical or horizontal bone augmentation procedures besides LSFA;
• Use of graft materials other than the specified DBBM or DPBM, or use of composite grafts;
• Heavy smoking (≥20 cigarettes/day), alcohol abuse, or history of substance abuse;
• Placement of multiple implants in the same grafted site (excluded to avoid within-patient confounding).

Sponsors & Collaborators

• Guoli Yang: lead
• The Dental Hospital of Zhejiang University School of Medicine: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

The Affiliated Hospital, School of Stomatology, Zhejiang University., Hangzhou, Zhejiang 310000

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (9)

• 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.

  PMID: 37610063 BACKGROUND

• 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.

  PMID: 35224778 BACKGROUND

• 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.

  PMID: 27324175 BACKGROUND

• 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.

  PMID: 24861978 BACKGROUND

• 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.

  PMID: 20977615 BACKGROUND

• 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.

  PMID: 20491813 BACKGROUND

• 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.

  PMID: 22092377 BACKGROUND

• 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.

  PMID: 19438954 BACKGROUND

• 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.

  PMID: 17209782 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)