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

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 - Maxillary sinus augmentation using porcine, bovine and alloplastic BSM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031628

Enrollment

Registered

2023-04-06

Start date

2017-04-05

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Patients with atrophic upper jaw before planned implant restoration

Interventions

Group 1: Maxillary sinus augmentation using a porcine bone substitute material before dental implant placement Group 2: Maxillary sinus augmentation using a bovine bone substitute material before dent

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactTobias Möst

Mund-, Kiefer- und Gesichtschirurgische Klinik

tobias.moest@uk-erlangen.de+4991318543728

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026