A Randomized Clinical Trial Evaluating rh-FGF-2/β-TCP in Periodontal Defects

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 i...

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Bibliographic Details
Published in:Journal of dental research Vol. 95; no. 5; p. 523
Main Authors: Cochran, D L, Oh, T-J, Mills, M P, Clem, D S, McClain, P K, Schallhorn, R A, McGuire, M K, Scheyer, E T, Giannobile, W V, Reddy, M S, Abou-Arraj, R V, Vassilopoulos, P J, Genco, R J, Geurs, N C, Takemura, A
Format: Journal Article
Language:English
Published: United States 01.05.2016
Subjects:
Adult
Aged
Alveolar Bone Loss - drug therapy
Alveolar Bone Loss - surgery
Bone Substitutes - therapeutic use
Calcium Phosphates - therapeutic use
Dental Scaling - methods
Dose-Response Relationship, Drug
Double-Blind Method
Female
Fibroblast Growth Factor 2 - administration & dosage
Fibroblast Growth Factor 2 - therapeutic use
Follow-Up Studies
Guided Tissue Regeneration, Periodontal - methods
Humans
Male
Middle Aged
Osteogenesis - drug effects
Osteogenesis - physiology
Periodontal Attachment Loss - drug therapy
Periodontal Attachment Loss - surgery
Prospective Studies
Recombinant Proteins
Root Planing - methods
Safety
Surgical Flaps - surgery
Tissue Scaffolds
Treatment Outcome
bone substitutes
alveolar bone loss
regeneration
biological factors
periodontal disease
randomized controlled trial
ISSN:1544-0591, 1544-0591
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Summary: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).
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ISSN:1544-0591
1544-0591
DOI:10.1177/0022034516632497