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

Guoli Yang

Status: Completed

Conditions: Sinus Floor Augmentation; Sinus Floor Elevation

Treatments: Procedure: Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral

Study type: Observational

Funder types: Other

Identifiers

NCT07182929

81901051, 82370991, 2022KY872 (Other Identifier)

2024-153(R)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

56 participants in 2 patient groups

DBBM

Description:

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

Treatment:

Procedure: Lateral Sinus Floor Augmentation with Deproteinized Porcine Bone Mineral

DPBM

Description:

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