Onderzoek naar kaakbotophoging met kunstbot en stamcellen voor tandwortelimplantate

Conditions: human maxillary sinus
atrophic maxilla
maxillary sinus floor elevation
adipose derived mesenchymal stem cells
bone tissue engineering
bone substitute

Registration Number: NL-OMON24484

Lead Sponsor: VU University medical center, De Boelelaan 1117, 1081 HV Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

minimal bone height of 4 mm at planned implant site(s)
- no local need for horizontal bone augmentation
- healthy appearance sinus maxillaris
- smoking below 10 sigarettes a day

Exclusion Criteria

- History of malignancy or chronic infectious disease (i.e. HIV, Hepatitis)
- irradiation history in jaw area
- destructive sinus surgery indicated during anamnesis
- endocarditis or heart valve abnormalities, or heart valve prostheses
- abnormalities in the immune system, or use of immune suppressants
- severe bone metabolic disorders (e.g. severe osteoporosis treated with bisphosphonates)
- Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or Non-Steroidal Anti-Inflammatory
Drugs (NSAIDS) within 15 days prior to lipoaspriation
- Signs or symptoms of infection at the time of any surgical procedure
- pregnant or nursing, or intention to become pregnant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: assessment of any AE or SAE related to the product and/or procedure, using patient questionnaires, physical examination, and laboratory measurements

Secondary Outcome Measures

Name	Time	Method
Efficacy: Radiological/clinical assessment of bone height, bone density, and/or bone loss; dental implant integration and survival (assessment by immobility, ankylotic percussion); and histological/histomorphometrical evaluation of biopsies taken 6 months after sinus lifting