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A phase I/II clinical trial to evaluate a combination of recombinant human platelet-derived growth factor-BB and recombinant human insulin-like growth factor-I in patients with periodontal disease
A phase I/II clinical trial to evaluate a combination of recombinant human platelet-derived growth factor-BB and recombinant human insulin-like growth factor-I in patients with periodontal disease
- Source :
- Journal of periodontology. 68(12)
- Publication Year :
- 1998
-
Abstract
- The primary objective of this study was to assess the safety of recombinant human (rh) platelet-derived growth factor-BB (PDGF-BB) and (rh) insulin-like growth factor-I (IGF-I) when applied to periodontal osseous defects in humans; a secondary objective was to begin to accrue data on the therapeutic dose of these growth factors (GFs) required to stimulate periodontal regeneration. Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design. Following full-thickness flap reflection, test sites received local application of the therapeutic drug delivered in coded syringes by a "masked" investigator. Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I). Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle. Safety analyses included physical examination, hematology, serum chemistry, urinalysis, antibody titers, and radiographic evaluation of bony changes. The primary therapeutic assessment was bone fill measured at re-entry 6 to 9 months after treatment. No local or systemic safety issues were found as a result of GF administration. No patients developed antibodies to the rhGF proteins. In subjects treated with LD-PDGF/IGF-I, there were no enhancements in periodontal regeneration compared to controls. However, in patients treated with HD-PDGF/IGF-I, statistically significant increases in alveolar bone formation were noted as measured by surgical re-entry 9 months following drug delivery (P < 0.05). This corresponded to an increase of 2.08 mm of new vertical bone height and 42.3% osseous defect fill in the HD-PDGF/IGF-I subjects versus only 0.75 mm and 18.5% gains in new bone height and osseous fill, respectively, in the controls. Furcation lesions, although limited in number, responded most favorably to treatment, with 2.8 mm horizontal osseous fill. The results from this study suggest that the local application of rhPDGF-BB and rhIGF-I to periodontal lesions is safe at the dose levels studied. LD-PDGF/IGF-I did not elicit increased defect fill compared to the control; however, HD-PDGF/IGF-I resulted in a significant promotion in bone regeneration. Additional studies are warranted to more fully characterize the effects of PDGF/IGF-I on periodontal regeneration in humans.
- Subjects :
- Adult
Male
medicine.medical_specialty
Bone Regeneration
Urinalysis
medicine.medical_treatment
Administration, Topical
Urology
Becaplermin
Antibodies
Surgical Flaps
law.invention
Therapeutic index
Randomized controlled trial
Double-Blind Method
law
Internal medicine
medicine
Alveolar Process
Humans
Regeneration
Insulin-Like Growth Factor I
Bone regeneration
Dental alveolus
Periodontal Diseases
Platelet-Derived Growth Factor
Hematology
medicine.diagnostic_test
business.industry
Growth factor
Furcation Defects
Proto-Oncogene Proteins c-sis
Middle Aged
Recombinant Proteins
Surgery
Evaluation Studies as Topic
Periodontics
Female
Pharmaceutical Vehicles
Safety
business
Gels
medicine.drug
Follow-Up Studies
Subjects
Details
- ISSN :
- 00223492
- Volume :
- 68
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- Journal of periodontology
- Accession number :
- edsair.doi.dedup.....883ad262bba7ca22fef61e49577d267d