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

Radiographic Assessment of Deproteinized Porcine Versus Bovine Bone Mineral in Sinus Augmentation: A Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07182929
Enrollment
56
Registered
2025-09-19
Start date
2024-01-01
Completion date
2025-07-01
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Floor Augmentation, Sinus Floor Elevation

Keywords

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

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.

Interventions

PROCEDURELateral 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

Sponsors

The Dental Hospital of Zhejiang University School of Medicine
CollaboratorOTHER
National Natural Science Foundation of China
CollaboratorOTHER_GOV
Guoli Yang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Apical Bone Height (ABH)immediately postoperatively (T1), and 6 months postoperatively (T2)The vertical distance (mm) from the implant apex to the most apical point of the graft material
Bone Height (BH)immediately postoperatively (T1), and 6 months postoperatively (T2)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
Endo-Sinus Bone Gain (ESBG)immediately postoperatively (T1), and 6 months postoperatively (T2)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
augmented volume (AV, mm³)immediately postoperatively (T1), and 6 months postoperatively (T2)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

Secondary

MeasureTime frameDescription
Peri-Implant Bone Level (PBL)immediately postoperatively (T1), and 6 months postoperatively (T2)The distance (mm) between the most coronal and the most apical levels of the implant-bone/graft contact interface. Site-specific measurements were denoted as buccal (bPBL), palatal (pPBL), mesial (mPBL), and distal (dPBL) peri-implant bone levels

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026