Clinical application of a porcine hydroxyapatite (The Graft) and an alloplastic ß-Tricalciumphosphate (Osopia) in comparison to a bovine hydroxyapatite (BioOss) for maxillary sinus augmentation: a radiological and histological analysis

Phase 4

• Conditions: Patients with atrophic upper jaw before planned implant restoration

• Registration Number: DRKS00031628
• Lead Sponsor: Mund-, Kiefer- und Gesichtschirurgische Klinik des Universitätsklinikums Erlangen

Brief Summary

Histological analysis: DPBM acts as an osteoconductive bone substitute material with a rate for newly formed bone comparable to DBBM 4 months after maxillary sinus augmentation. Within the testing groups microstructured BCP showed a higher proportion of NFB, whereby compared to the control and testing groups no statistaical significant differences exists. Radiological analysis: Concerning bone graft stability/ volume DBBM and DPBM show comparable outcomes. Due to resorption, BCP showed inferior bone graft volume after healing (statistically significant) compared to DBBM and DPBM.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-19
• Study Start: 2023-04-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

edentulous upper jaw or residual dentition in the upper jaw posterior region
- insufficient bone supply in height and width
- remaining bone height in the maxillary alveolar crest between 4 and 6 mm

Exclusion Criteria

- Acute infections
- Acute sinusitis
- Radiotherapy in the head and/or neck area
- Chemotherapy
- Poor oral hygiene or motivation
- Active periodontitis
- Pregnancy
- Drug or alcohol abuse
- Smoker (>10 p.d.)
- Hematological diseases
-Metabolic
- Uncontrolled or treatment-resistant diabetes
- Autoimmune diseases
- Immunological diseases
- Chronic osteopathies
- Antiresorptive medication (bisphosphonates, anti-RANKL antibodies, anti-VEGF antibodies, tyrosine kinase inhibitor, mTOR inhibitor)
- Steroid medication
- Untreated carious lesions of neighboring teeth
- Untreated endodontic lesions of neighboring teeth
- Limited mental abilities and language skills, so that study information and instructions cannot be understood

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological characterisation of degradation and integration patters of 1. A deproteinized bovine bone mineral (DBBM, Bio-Oss®, Geistlich Biomaterials GmbH, Baden-Baden, Germany), 2. A deproteinized porcine bone mineral (DPBM, THE Graft®, Regedent GmbH, Dettelbach, Germany) and 3. A synthetic tricalciumphosphate (BCP, Osopia®, Regedent GmbH, Dettelbach, Germany) in a two- staged sinus grafting setup

Secondary Outcome Measures

Name	Time	Method
The three- dimensional evaluation of graft alterations in the maxillary sinus, by means of 3D analyses of CBCT scan follow- ups to describe dimensional changes that are associated with osseous graft consolidation.