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NCT Number: NCT07182929

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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

Primary outcomes

  1. Apical Bone Height (ABH)

    Time frame: 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

  2. Bone Height (BH)

    Time frame: 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

  3. Endo-Sinus Bone Gain (ESBG)

    Time frame: 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

  4. augmented volume (AV, mm³)

    Time frame: 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 outcomes

  1. Peri-Implant Bone Level (PBL)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Guoli Yang

Other

Collaborators

  • National Natural Science Foundation of China
  • The Dental Hospital of Zhejiang University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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