The safety and efficacy of an injectable bone substitute in dental sockets demonstrated in a human clinical trial.
This study is the first report of a clinical evaluation of an injectable bone substitute (IBS). This IBS was prepared by suspending biphasic calcium phosphate (BCP) particles with diameters ranging between 80 and 200 microm in a water-soluble cellulose polymer carrier phase. It was used for filling bone defects after tooth extractions in 11 patients. The first objective of the study was to investigate the safety of the filler material. The second objective was to investigate the efficacy of the material for filling human tooth sockets and preventing alveolar bone loss. Radiographic density measurements of the surgical sites gradually increased to those of the surrounding host bone. Three years after surgery, small biopsies of the implanted areas were harvested and analyzed by using micro-computed tomography, non-decalcified histology and histomorphometry. The BCP granules appeared in direct contact with mineralized bone tissue, thereby supporting bone growth. A gradual substitution of the filler by bone tissue was observed thus preserving the height of the alveolar bone crest.
Weiss
Pierre
P
INSERM, U 791, Laboratory for Osteo-articular and Dental Tissue Engineering, 1 Place Alexis Ricordeau, Nantes 44042, France. pierre.weiss@univ-nantes.fr <pierre.weiss@univ-nantes.fr>
Layrolle
Pierre
P
Clergeau
Léon Philippe
LP
Enckel
Bénédicte
B
Pilet
Paul
P
Amouriq
Yves
Y
Daculsi
Guy
G
Giumelli
Bernard
B
D000328:Adult; D001672:Biocompatible Materials / Q000737:chemistry*; D001862:Bone Resorption; D018786:Bone Substitutes / Q000737:chemistry*; D001842:Bone and Bones / Q000187:drug effects; D002130:Calcium Phosphates / Q000737:chemistry*; D002482:Cellulose / Q000737:chemistry; D003758:Dental Implantation, Endosseous / Q000379:methods; D015921:Dental Implants; D004337:Drug Carriers; D005260:Female; D006801:Humans; D008297:Male; D008334:Mandible / Q000473:pathology; D016348:Osseointegration; D020390:Tooth Socket / Q000187:drug effects*
D001672:Biocompatible Materials; D018786:Bone Substitutes; D002130:Calcium Phosphates; D015921:Dental Implants; D004337:Drug Carriers; D002482:Cellulose; C020243:calcium phosphate