Abstract
BackgroundThe options for medical use of signaling molecules as stimulators of tissue regeneration are currently limited. Preclinical evidence suggests that fibroblast growth factor (FGF)-2 can promote periodontal regeneration. This study aimed to clarify the activity of FGF-2 in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.Methodology/Principal FindingsWe used recombinant human FGF-2 with 3% hydroxypropylcellulose (HPC) as vehicle and conducted a randomized double-blinded controlled trial involving 13 facilities. Subjects comprised 74 patients displaying a 2- or 3-walled vertical bone defect as measured ≥3 mm apical to the bone crest. Patients were randomly assigned to 4 groups: Group P, given HPC with no FGF-2; Group L, given HPC containing 0.03% FGF-2; Group M, given HPC containing 0.1% FGF-2; and Group H, given HPC containing 0.3% FGF-2. Each patient underwent flap operation during which we administered 200 µL of the appropriate investigational drug to the bone defect. Before and for 36 weeks following administration, patients underwent periodontal tissue inspections and standardized radiography of the region under investigation. As a result, a significant difference (p = 0.021) in rate of increase in alveolar bone height was identified between Group P (23.92%) and Group H (58.62%) at 36 weeks. The linear increase in alveolar bone height at 36 weeks in Group P and H was 0.95 mm and 1.85 mm, respectively (p = 0.132). No serious adverse events attributable to the investigational drug were identified.ConclusionsAlthough no statistically significant differences were noted for gains in clinical attachment level and alveolar bone gain for FGF-2 groups versus Group P, the significant difference in rate of increase in alveolar bone height (p = 0.021) between Groups P and H at 36 weeks suggests that some efficacy could be expected from FGF-2 in stimulating regeneration of periodontal tissue in patients with periodontitis.Trial RegistrationClinicalTrials.gov NCT00514657
Highlights
Periodontitis, evoked by the bacterial biofilm that forms around teeth, progressively destroys the periodontal tissue supporting the teeth, including the periodontal ligament, cementum, alveolar bone and gingiva
Conclusions: no statistically significant differences were noted for gains in clinical attachment level and alveolar bone gain for fibroblast growth factor (FGF)-2 groups versus Group P, the significant difference in rate of increase in alveolar bone height (p = 0.021) between Groups P and H at 36 weeks suggests that some efficacy could be expected from FGF-2 in stimulating regeneration of periodontal tissue in patients with periodontitis
The 91 patients screened as subjects were consenting periodontitis patients for whom periodontal tissue regeneration therapy was indicated by investigators based on these criteria among a large number of potential subjects
Summary
Periodontitis, evoked by the bacterial biofilm (dental plaque) that forms around teeth, progressively destroys the periodontal tissue supporting the teeth, including the periodontal ligament, cementum, alveolar bone and gingiva This chronic inflammatory disease can lead to loss of the affected teeth [1,2,3]. Removal of the cause, bacterial plaque, with conventional periodontal and/or surgical treatments can, at best, reduce pocket depth and diminish inflammation in the affected region. No such treatment can ever regenerate lost periodontal tissue or normal structure and functionality. This study aimed to clarify the activity of FGF-2 in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation
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