Clinical evaluation of the combination of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (P-15) in particulate and hydrogel form as a bone replacement graft material in human periodontal osseous defects: 6-month reentry controlled clinical study.
BACKGROUND
This prospective, randomized, controlled clinical trial study compared the clinical outcomes of the biomaterial anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (ABM/P-15) as a biocompatible hydrogel carrier consisting of carboxymethylcellulose and glycerol or in particulate form when used as a bone replacement graft in the treatment of human periodontal infrabony defects.


METHODS
Nineteen patients with advanced chronic periodontitis were recruited. All patients had at least two non-adjacent intrabony osseous defects > or = 3 mm after completion of cause-related periodontal therapy. The surgical procedures included access flaps for root instrumentation and filling the defect with ABM/P-15 in hydrogel or particulate form. Reentry access flap surgery was performed at 6 months. Changes in soft and hard tissue outcome measurements between baseline and 6 months were evaluated in all defects.


RESULTS
At 6 months, no significant differences between ABM/P-15 hydrogel and ABM/P-15 particulate were demonstrated for the amount of defect fill (3.10 +/- 0.85 mm [75.0%] versus 3.09 +/- 1.11 mm [73.7%], respectively) or defect resolution (85.8% versus 81.9%). Changes in soft tissue clinical outcomes did not show significant differences between the treatments.


CONCLUSIONS
This trial failed to demonstrate superiority of the novel ABM/P-15 hydrogel therapeutic modality over the standard ABM/ P-15 particulate graft in the treatment of intrabony periodontal defects.
Matos
Sérgio M
SM
Department of Dental Medicine, Stomatology, and Maxillofacial Surgery, Faculty of Medicine, University of Coimbra, Coimbra, Portugal. sergiomatos1@sapo.pt
Guerra
Fernando A
FA
Krauser
Jack
J
Marques
Francisco
F
Ermida
Jorge M
JM
Sanz
Mariano
M
D000328:Adult; D016301:Alveolar Bone Loss / Q000209:etiology / Q000601:surgery*; D000818:Animals; D001861:Bone Regeneration; D018786:Bone Substitutes; D002266:Carboxymethylcellulose Sodium; D002417:Cattle; D003094:Collagen / Q000627:therapeutic use*; D005260:Female; D005990:Glycerol; D006801:Humans; D020100:Hydrogels / Q000737:chemistry; D006882:Hydroxyapatites; D008297:Male; D008875:Middle Aged; D019647:Oral Surgical Procedures / Q000379:methods*; D010316:Particle Size; D010446:Peptide Fragments / Q000627:therapeutic use*; D010518:Periodontitis / Q000150:complications; D011446:Prospective Studies; D016896:Treatment Outcome
D018786:Bone Substitutes; D020100:Hydrogels; D006882:Hydroxyapatites; D010446:Peptide Fragments; C407062:cell-binding peptide P-15; D003094:Collagen; D002266:Carboxymethylcellulose Sodium; D005990:Glycerol