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 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42402

Enrollment

Registered

2015-10-13

Start date

2016-11-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Alveolar resorption shrinking of the jaw

Interventions

Patients fulfilling all inclusion criteria will be requested for informed consent and scheduled for sinus floor elevation surgery with CPC-PLGA. Surgery is performed under local anesthesia. Prophyla

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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 - Previous entry into this study or participation in any other clinical trial within 30 days

Design outcomes

Primary

Measure	Time frame
• Biopsy specimens from each patient at 5 months after sinus floor elevation surgery will be analyzed histomorphometrically on bone formation. • Implant survival is assessed at 5, 11, 17 and 23 months after sinus floor elevation surgery.	—

Secondary

Measure	Time frame
Pain and health related quality of life questionnaire at 7 time-points.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)