Microstructured BCP granules as bone graft substitute in maxillary sinus floor augmentation with two-stage implant placement

Microstructured BCP granules as bone graft substitute in maxillary sinus floor augmentation with two-stage implant placement - Sinus floor augmentation with microstructured BCP granules

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47531

Enrollment

Registered

2017-09-06

Start date

2018-02-06

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

atrophic posterior maxilla reduced bone height of the sinus floor

Interventions

Patients will undergo sinus floor augmentation with MagnetOs BCP granules as bone graft substitute or with autologous bone graft. A biopsy will be obtained from the maxilla before implant placement.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male or female patients aged 18-75 years * Presence of a unilateral or bilateral partial maxillary edentulism involving the premolar/molar areas * Presence of a residual posterior maxillary bone height between 2 and 6 mm * Patient qualifies for sinus augmentation surgery * Smoking *10 cigarettes per day

Exclusion criteria

Exclusion criteria: * Maxillary sinus pathology * Presence of a local or systemic disease or treatment affecting bone formation * Contamination of the (area around the) operative field * Periodontitis * Infectious diseases * Bone metabolic disease * Neurological disorders that could influence mental validity * Pregnant or breast-feeding women * Cancer therapy including immune-suppression, chemotherapy and radiation * Patients in which primary stability could not be established * Previous entry into this study or participation in any other clinical trial within 30 days * Smoking >10 cigarettes per day

Design outcomes

Primary

Measure	Time frame
- Percentage of new bone formation in the augmented sinus floor by histomorphometrical analysis of biopsy specimens at 5 months of follow up.	—

Secondary

Measure	Time frame
- Implant survival rate and adverse events during 17 months of follow up. - Augmented bone height as measured by CBCT at 5, 11 and 17 months of follow up. - Implant stability quotient (ISQ) as measured by resonance frequency analysis (RFA) at 5 months (primary stability) and 11 months of follow-up. - Scoring of gingival index, supra-gingival plaque index, and dichotomous bleeding index 17 months after surgery. - Probing depth of implant and adjacent teeth (buccal, distal, palatinal, mesial) at 17 months after surgery. - Pain by the Visual Analogue Scale (VAS-score) at visit 2 (baseline) to 6.	—

Measure

Time frame

- Implant survival rate and adverse events during 17 months of follow up. - Augmented bone height as measured by CBCT at 5, 11 and 17 months of follow up. - Implant stability quotient (ISQ) as measured by resonance frequency analysis (RFA) at 5 months (primary stability) and 11 months of follow-up. - Scoring of gingival index, supra-gingival plaque index, and dichotomous bleeding index 17 months after surgery. - Probing depth of implant and adjacent teeth (buccal, distal, palatinal, mesial) at 17 months after surgery. - Pain by the Visual Analogue Scale (VAS-score) at visit 2 (baseline) to 6.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)