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

Péter Windisch, Andreas Stavropoulos, Bálint Molnár, Dóra Szendröi-Kiss, Emese Szilágyi, Péter Rosta, Attila Horváth, Björn Capsius, Ulf M E Wikesjö, Anton Sculean

Research output: Contribution to journalArticle

16 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1181-1189
Number of pages9
JournalClinical oral investigations
Volume16
Issue number4
DOIs
StatePublished - Aug 1 2012

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Debridement
Safety
Periodontal Index
Antibody Formation
Therapeutics
Phosphate Transport Proteins
Chronic Periodontitis
Clinical Chemistry
Hematology
Tooth
Randomized Controlled Trials

Keywords

  • Clinical trial
  • Periodontal regeneration
  • Periodontal surgery
  • Tissue engineering
  • rhGDF-5
  • β-TCP

ASJC Scopus subject areas

  • Dentistry(all)

Cite this

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. / Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton.

In: Clinical oral investigations, Vol. 16, No. 4, 01.08.2012, p. 1181-1189.

Research output: Contribution to journalArticle

Windisch, P, Stavropoulos, A, Molnár, B, Szendröi-Kiss, D, Szilágyi, E, Rosta, P, Horváth, A, Capsius, B, Wikesjö, UME & Sculean, A 2012, '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', Clinical oral investigations, vol. 16, no. 4, pp. 1181-1189. https://doi.org/10.1007/s00784-011-0610-3
Windisch, Péter ; Stavropoulos, Andreas ; Molnár, Bálint ; Szendröi-Kiss, Dóra ; Szilágyi, Emese ; Rosta, Péter ; Horváth, Attila ; Capsius, Björn ; Wikesjö, Ulf M E ; Sculean, Anton. / 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. In: Clinical oral investigations. 2012 ; Vol. 16, No. 4. pp. 1181-1189.
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