Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with β-tricalcium phosphate in human intra-osseous periodontal defects.
OBJECTIVE
the objective of the study was to evaluate the safety and efficacy of a formulation containing recombinant human platelet-derived growth factor (rhPDGF-BB) and β-tricalcium phosphate (β-TCP) in patients with periodontal defects and to compare it with those of β-TCP alone.


METHODS
in this double-blind, prospective, parallel, active-controlled, randomized, multi-centre clinical trial, 54 patients with periodontal osseous defects were randomly assigned to rhPDGF-BB+β-TCP or β-TCP. Following periodontal surgery, respective implantation was performed. The primary and secondary end points of treatment were evaluated at the third and the sixth month.


RESULTS
among the outcome measures, the extent of linear bone growth (p<0.01) and per cent bone fill (p<0.004) at the sixth month over baseline were significantly higher in the rhPDGF-BB+β-TCP group when compared with the β-TCP group. Similarly, it also resulted in significantly higher area under the curve clinical attachment level gain at 0-6 months (p<0.01), CAL gain and greater reduction in probing depth at the third and the sixth month than that with β-TCP treatment alone. The incidence of adverse events was similar in both the groups and no serious adverse events were reported in any of the patients.


CONCLUSIONS
rhPDGF-BB+β-TCP is safe and effective in the treatment of periodontal defects. It increases bone formation and soft tissue healing (clinicaltrials.gov, number NCT00496847; CTRI No.: CTRI/2008/091/000152).
Department of Periodontics, Sri Sai College of Dental Surgery, Vikarabad, AP, India. avulajk@rediffmail.com
Avula
A
Jayakumar
Palaparthi
P
Rajababu
Surabhi
S
Rohini
Kalakonda
K
Butchibabu
Anumala
A
Naveen
Pathakota Krishnajaneya
PK
Reddy
Sisinty
S
Vidyasagar
Durvasula
D
Satyanarayana
Sayini
S
Pavan Kumar
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D016301:Alveolar Bone Loss / Q000188:drug therapy* / Q000601:surgery; D019540:Area Under Curve; D000077214:Becaplermin; D001672:Biocompatible Materials / Q000627:therapeutic use; D001861:Bone Regeneration / Q000187:drug effects*; D018786:Bone Substitutes / Q000627:therapeutic use*; D002130:Calcium Phosphates / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010510:Periodontal Diseases / Q000188:drug therapy / Q000601:surgery; D010982:Platelet-Derived Growth Factor / Q000502:physiology* / Q000627:therapeutic use; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D018709:Statistics, Nonparametric; D054457:Tissue Scaffolds; D016896:Treatment Outcome
D001672:Biocompatible Materials; D018786:Bone Substitutes; D002130:Calcium Phosphates; D004338:Drug Combinations; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; C485817:beta-tricalcium phosphate; D000077214:Becaplermin