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A Randomized Clinical Trial Evaluating rh-FGF-2/β-TCP in Periodontal Defects.
- Source :
- Journal of Dental Research; May2016, Vol. 95 Issue 5, p523-530, 8p, 2 Diagrams, 2 Charts, 1 Graph
- Publication Year :
- 2016
-
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). [ABSTRACT FROM AUTHOR]
- Subjects :
- PERIODONTAL disease
REGENERATION (Biology)
FIBROBLAST growth factor 2
CALCIUM phosphate
DENTAL scaling
TOOTH root planing
BONE growth
ADVERSE health care events
PHOSPHATES
BONE substitutes
COMPARATIVE studies
CULTURE media (Biology)
DOSE-effect relationship in pharmacology
SURGICAL flaps
GROWTH factors
GUIDED tissue regeneration
LONGITUDINAL method
RESEARCH methodology
MEDICAL cooperation
RECOMBINANT proteins
RESEARCH
SAFETY
EVALUATION research
TREATMENT effectiveness
BLIND experiment
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 00220345
- Volume :
- 95
- Issue :
- 5
- Database :
- Complementary Index
- Journal :
- Journal of Dental Research
- Publication Type :
- Academic Journal
- Accession number :
- 114697702
- Full Text :
- https://doi.org/10.1177/0022034516632497