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

NCT ID: NCT07182929

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sinus Floor Elevation Sinus Floor Augmentation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Aged between 18 and 80 years;
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

1. Uncontrolled systemic diseases or any bone-metabolism diseases;
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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Dental Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Guoli Yang

OTHER

Sponsor Role lead

Responsible Party

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Guoli Yang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Hangzhou, Zhejiang, China

Site Status

Countries

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China

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.

Reference Type BACKGROUND
PMID: 37610063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35224778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27324175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24861978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20977615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20491813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22092377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19438954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17209782 (View on PubMed)

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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