Stem Cells Cultured on Beta Tricalcium Phosphate (β-TCP) in Combination with Recombinant Human Platelet-Derived Growth Factor - BB (rh-PDGF-BB) for the Treatment of Human Infrabony Defects.

Knowledge gained from the field of tissue engineering, helped to develop a biological substitute that promotes tissue regeneration. The usual biological substitute consists of stem cells, growth factors and an appropriate scaffold. The present randomized controlled clinical and radiographic study was undertaken to evaluate the effectiveness of mesenchymal stem cells cultured on beta tricalcium phosphate (β-TCP) in combination with rh-PDGF-BB in treatment of infrabony defect in humans. A total of 24 infrabony defects in 14 systemically healthy patients were selected for the present study. The selected defects exhibited a probing pocket depth (PPD) of ≥ 5 mm and depth of infrabony component ≥ 3 mm as assessed by clinical and radiographic measurements and later confirmed by intrasurgical measurement. Baseline measurements included were Plaque Index (PI), Papillary Bleeding Index (PBI), Probing Pocket Depth (PPD), Relative gingival marginal level (RGML), Relative Clinical Attachment Level (R-CAL) and Radiographic Defect Depth (DD) and linear bone growth (LBG). 6 weeks after initial therapy, the defects were randomly assigned to either test group or control group. The control group was treated by an open flap debridement (OFD) only, while the test group was treated by a Stem cells cultured on β-TCP in combination with rh-PDGF-BB. All the measurements recorded preoperatively were repeated at 6 months after the surgery. The efficacy of each treatment modality was investigated through statistical analysis. Mean probing pocket depth reduction was significantly greater in test group (4.50 ± 1.08 mm) compared to the OFD group (3.50 ± 0.90 mm). Mean gains in clinical attachment level was 3.91 ± 1.37 mm in the test group and 2.08 ± 0.90 mm in the control group. The mean increase in gingival recession (GR) was less in test group (0.58 ± 0.79 mm) compared to OFD group (1.4 ± 0.66 mm). Radiographic defect depth reduction was greater in the test group (3.50 ± 0.67 mm) with 88.33% defect fill compared to control group (1.83 ± 0.38 mm) with only 52.77% defect fill. Linear bone growth (LBG) was significantly improved by 3.58 mm in test group, while in control group, it was 1.83 mm. Regenerative approach using Stem cells cultured on β-TCP in combination with rh-PDGF-BB for the treatment of human infrabony defects resulted in a significant added benefit in terms of CAL gains, PPD reductions greater radiographic defect fill and improvement in Linear bone growth (LBG) compared to the OFD alone.

RCT Entities:   Population Interventions Outcomes