jaw bone athrophy jaw bone loss
Conditions
Interventions
There will be three surgical interventions:
1. Sinus floor elevation procedure: This intervention will consist of two arms:
In the first arm, the acquisition of abdominal adipose tissue, its automate
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 - Age 18 years or older
Exclusion criteria
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 the surgical procedure - pregnant or nursing, or intention to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any AE or SAE related to the product and/or procedure (in order to determine the follow-up regime for dose-response studies) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Radiological/clinical assessment of bone formation 2) Histological/histomorphometrical evaluation of biopsies taken 6 months after sinus floor elevation | — |
Countries
Netherlands
Outcome results
None listed