title: A Randomized Clinical Trial Evaluating rh-FGF-2/β-TCP in Periodontal Defects.
abstract: Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a β-tricalcium phosphate (β-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-β-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with β-TCP-following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/β-TCP groups with significant improvements over control and 0.1% rh-FGF-2/β-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/β-TCP (ClinicalTrials.gov NCT01728844).
authors.affiliation: Department of Periodontics, The University of Texas Health Science Center at San Antonio, San Antonio, TX, USA Cochran@uthscsa.edu.
authors.forename: D L
authors.initials: DL
authors.lastname: Cochran
authors.affiliation: Department of Periodontics and Oral Medicine, Michigan Center for Oral Health Research, University of Michigan School of Dentistry, Ann Arbor, MI, USA.
authors.forename: T-J
authors.initials: TJ
authors.lastname: Oh
authors.affiliation: Department of Periodontics, The University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
authors.forename: M P
authors.initials: MP
authors.lastname: Mills
authors.affiliation: Regenerative Solutions, Fullerton, CA, USA.
authors.forename: D S
authors.initials: DS
authors.lastname: Clem
authors.affiliation: Private practice, Aurora, CO, USA.
authors.forename: P K
authors.initials: PK
authors.lastname: McClain
authors.affiliation: Private practice, Aurora, CO, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Schallhorn
authors.affiliation: Perio Health Professionals, Houston, TX, USA.
authors.forename: M K
authors.initials: MK
authors.lastname: McGuire
authors.affiliation: Perio Health Professionals, Houston, TX, USA.
authors.forename: E T
authors.initials: ET
authors.lastname: Scheyer
authors.affiliation: Department of Periodontics and Oral Medicine, Michigan Center for Oral Health Research, University of Michigan School of Dentistry, Ann Arbor, MI, USA.
authors.forename: W V
authors.initials: WV
authors.lastname: Giannobile
authors.affiliation: Department of Periodontology, School of Dentistry, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Reddy
authors.affiliation: Department of Periodontology, School of Dentistry, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: R V
authors.initials: RV
authors.lastname: Abou-Arraj
authors.affiliation: Department of Periodontology, School of Dentistry, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: P J
authors.initials: PJ
authors.lastname: Vassilopoulos
authors.affiliation: University at Buffalo, SUNY, Department of Oral Biology, Buffalo, NY, USA.
authors.forename: R J
authors.initials: RJ
authors.lastname: Genco
authors.affiliation: Department of Periodontology, School of Dentistry, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: N C
authors.initials: NC
authors.lastname: Geurs
authors.affiliation: Sunstar Americas, Inc., Schaumburg, IL, USA.
authors.forename: A
authors.initials: A
authors.lastname: Takemura
mesh_terms: D000328:Adult; D000368:Aged; D016301:Alveolar Bone Loss / Q000188:drug therapy / Q000601:surgery*; D018786:Bone Substitutes / Q000627:therapeutic use*; D002130:Calcium Phosphates / Q000627:therapeutic use*; D012534:Dental Scaling / Q000379:methods; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D010012:Osteogenesis / Q000187:drug effects / Q000502:physiology; D017622:Periodontal Attachment Loss / Q000188:drug therapy / Q000601:surgery; D011446:Prospective Studies; D011994:Recombinant Proteins; D016745:Root Planing / Q000379:methods; D012449:Safety; D013524:Surgical Flaps / Q000601:surgery; D054457:Tissue Scaffolds; D016896:Treatment Outcome
chemical_list: D018786:Bone Substitutes; D002130:Calcium Phosphates; D011994:Recombinant Proteins; C485817:beta-tricalcium phosphate; D016222:Fibroblast Growth Factor 2
keywords: alveolar bone loss; biological factors; bone substitutes; periodontal disease; randomized controlled trial; regeneration