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

Phase 4

Recruiting

Conditions: atrophic posterior maxilla
reduced bone height of the sinus floor
10019190

Registration Number: NL-OMON47531

Lead Sponsor: MKA chirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Percentage of new bone formation in the augmented sinus floor by<br /><br>histomorphometrical analysis of biopsy specimens at 5 months of follow up.</p><br>

Secondary Outcome Measures

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