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

Withdrawn

Conditions: Mond- en kaakchirurgie
atrophic posterior maxilla
reduced bone height of the sinus floor

Registration Number: NL-OMON43080

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* Male or female patients aged 18-70 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

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
* Psychologic instability
* Neurological disorders that could influence mental validity
* Smoking
* Female of child bearing potential, who are pregnant or breast-feeding
* 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

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, volume and bone-implant-contact area (only at 11 and<br /><br>17 months) in relation to the endosseous dental implant as measured by CBCT at<br /><br>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 (after implant placement) 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 (buccodistal, buccomedial,<br /><br>buccomesial) at 17 months after surgery.<br /><br>- Pain by the Visual Analogue Scale (VAS-score) at visit 2 to 6.</p><br>