A clinical, prospective feasibility study to assess the effectiveness and safety of micro-structured TCP granules as a bone augmentation material in sinus floor elevation procedures. - The effectiveness of micro-structured TCP granules as a bone graft.

niversitair Medisch Centrum Sint Radboud0 sites10 target enrollmentTBD

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: niversitair Medisch Centrum Sint Radboud
Enrollment: 10
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

niversitair Medisch Centrum Sint Radboud

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged 18\-70 years
•Patient is willing to give informed consent to participate in the study
•Patient qualifies for sinus augmentation surgery
•Presence of a maxillary, unilateral or bilateral, (partial) edentulism involving the premolar/molar areas
•Presence of a residual alveolar ridge height between 3 and 8 mm

Exclusion Criteria

•Maxillary sinus pathology
•Recent extractions in the involved area
•Presence of a local or systemic disease or treatment affecting bone formation
•Contamination of the (area around the) operative field
•Infectious diseases
•Bone metabolic disease
•Psychologic instability
•Neurological disorders that could influence mental validity
•Female of child bearing potential, who are pregnant or breast\-feeding
•Cancer therapy including immune\-suppression, chemotherapy and radiation

Outcomes

Primary Outcomes

Not specified

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