Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration (NCT02153268) | Clinical Trial Compass
CompletedPhase 1/2
Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration
Israel11 participantsStarted 2014-02
Plain-language summary
Phase I/II open label first in human single center clinical study, is to evaluate the safety and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area approximately 6 month follow up after implantation in the following two clinical indications:
1. Bone augmentation (e.g. sinus augmentation)
2. Bone grafting after removal of cysts from jaws
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
The inclusion criteria defining the eligible subjects are divided to two groups according clinical indications:
Sinus augmentation
* Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
* Subjects that have a rehabilitation dentist and rehabilitation program
* Up to dated panoramic X-Ray.
* Subjects who provided written informed consent to participate in the study, able to understand study procedure and agree for follow up procedures
* Healthy conditions of Maxillary Sinuses and Oral Mucosa.
* Sub-antral bone at least 4 mm as measured on CBCT/CT.
* Have a good oral hygiene condition as per investigator discretion.
Bone grafting after removal of cysts from jaws
* Healthy subject.
* Subjects that have a rehabilitation dental treatment.
* Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
* Subjects referred to oral \& maxillofacial Dpt for removal of cysts after diagnosis of the cyst type.
* Healthy bone determined by X-ray.
* Have a good oral hygiene condition.
* Subject that does not participate in other clinical study.
* Subject able to read and understand and sign the informed consent
Exclusion Criteria:
* Subjects with recorded medical history diseases as: diabetes mellitus, heart diseases, renal failure, osteoporosis.
* Subject treated with systemic steroid treatment
* Subjects wit…
What they're measuring
1
BonoFill is safe
Timeframe: approximately 6 month follow up after implantation