A clinical, prospective feasibility study to assess the effectiveness and safety of micro-structured TCP granules as a bone augmentation material in sinus floor elevation procedures.

Phase 2

Recruiting

• Conditions: Tandheelkundige behandeling; boneloss; Upper jaw augmentation; 10005959

• Registration Number: NL-OMON32900
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

•Male or female patients aged 18-70 years
•Patient is willing to give informed consent to participate in the study
•Patient qualifies for sinus augmentation surgery
•Presence of a maxillary, unilateral or bilateral, (partial) edentulism involving the premolar/molar areas
•Presence of a residual alveolar ridge height between 3 and 8 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
•Psychologic instability
•Neurological disorders that could influence mental validity
•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 trail within 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>•Percentage of new bone formation will be evaluated by micro-CT and<br /><br>histological analysis of biopsy specimens; for each biopsy from each patient at<br /><br>5 months after augmentation surgery<br /><br>•Function of the inserted endosseous dental implants, at different<br /><br>time-intervals after surgery<br /><br>•Pain<br /><br>•Health related quality of life (SF-36)<br /><br>•Economical evaluation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>