title: A phase IIa randomized controlled pilot study evaluating the safety and clinical outcomes following the use of rhGDF-5/β-TCP in regenerative periodontal therapy.
abstract: To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy.
authors: Department of Periodontology, Semmelweis University, Budapest, Hungary.
authors: Péter
authors: P
authors: Windisch
authors: Andreas
authors: A
authors: Stavropoulos
authors: Bálint
authors: B
authors: Molnár
authors: Dóra
authors: D
authors: Szendröi-Kiss
authors: Emese
authors: E
authors: Szilágyi
authors: Péter
authors: P
authors: Rosta
authors: Attila
authors: A
authors: Horváth
authors: Björn
authors: B
authors: Capsius
authors: Ulf M E
authors: UM
authors: Wikesjö
authors: Anton
authors: A
authors: Sculean
mesh_terms: D000328:Adult; D000368:Aged; D016301:Alveolar Bone Loss / Q000601:surgery; D000917:Antibody Formation / Q000276:immunology; D001672:Biocompatible Materials / Q000737:chemistry*; D002130:Calcium Phosphates / Q000737:chemistry*; D055113:Chronic Periodontitis / Q000601:surgery; D003646:Debridement; D003774:Dental Plaque Index; D004337:Drug Carriers; D005260:Female; D005500:Follow-Up Studies; D005889:Gingival Recession / Q000601:surgery; D055428:Growth Differentiation Factor 5 / Q000097:blood / Q000276:immunology / Q000627:therapeutic use*; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017622:Periodontal Attachment Loss / Q000601:surgery; D010512:Periodontal Index; D010514:Periodontal Pocket / Q000601:surgery; D010865:Pilot Projects; D016300:Radiography, Bitewing; D011994:Recombinant Proteins; D012449:Safety; D013524:Surgical Flaps; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D002130:Calcium Phosphates; D004337:Drug Carriers; D055428:Growth Differentiation Factor 5; D011994:Recombinant Proteins; C485817:beta-tricalcium phosphate