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Clinical Trials/NL-OMON42402
NL-OMON42402
Completed
Not Applicable

A clinical prospective feasibility study to address the effectiveness and safety of calciumphosphate/poly(lactic-co-glycolic-acid) for bone augmentation in maxillary sinus floor elevation surgery. - A clinical feasibility study on the effectivenes and safety of CPC-PLGA.

niversitair Medisch Centrum Sint Radboud0 sites11 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar resorption
Sponsor
niversitair Medisch Centrum Sint Radboud
Enrollment
11
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

Eligibility Criteria

Inclusion Criteria

  • \- Healthy male or female patients aged 18\-70 years
  • \- Patient qualifies for sinus floor elevation surgery
  • \- Presence of a maxillary, unilateral or bilateral, (partial) edentulous area involving the premolar and/or molar area
  • \- Presence of a residual alveolar ridge height between 3 and 6 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
  • \- Neurological disorders that could influence mental validity
  • \- Pregnant or breast\-feeding female patients
  • \- Patients undergoing cancer therapy including immune suppression, chemotherapy and radiation
  • \- Patients with a history of implant failure

Outcomes

Primary Outcomes

Not specified

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