Injectable platelet rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: A randomized controlled clinical trial Running head: I-PRF with DFDBA in periodontal intrabony defects

Abstract Aim: The current randomized controlled clinical trial assessed the effect of injectable platelets rich fibrin (I-PRF) combined with demineralized freeze-dried bone allograft (DFDBA) compared to DFDBA alone in the management of intrabony defects of stage-III periodontitis patients. Methodology: Following sample size calculation, twenty stage-III periodontitis patients with ≥5mm clinical attachment level (CAL)-loss and ≥3mm intrabony defects were randomized into test (I-PRF+DFDBA; n=10) and control (DFDBA; n=10) groups. CAL (primary-outcome), periodontal probing depth (PPD), gingival recession depth (GRD), full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), radiographic linear defect depth (RLDD) and bone fill (secondary outcomes) were examined at baseline, 3, 6 and 9 months post-surgically. Results: I-PRF+DFDBA and DFDBA independently demonstrated significant intragroup CAL-gain, PPD- and RLDD-reduction at 3, 6 and 9 months (p<0.05), with no significant intergroup differences observed (p>0.05). CAL-gain (mean±SD) of 2.40±0.70mm and 2.50±0.85mm and PPD-reduction of 3.50±1.18mm and 2.80±0.42mm were demonstrated for I-PRF+DFDBA and DFDBA at 9 months respectively. Both groups showed significant intragroup RLDD improvement, with a RLDD of 3.58±0.66mm and 3.89±1.57mm for I-PRF+DFDBA and DFDBA at 9 months respectively. Stepwise linear regression analysis revealed that baseline RLDD and bone fill at 9 months were significant predictors of CAL (p<0.05). Conclusion: Within the present study’s limitations, DFDBA with or without I-PRF resulted in significant improvement in clinical and radiographic periodontal parameters in the surgical treatment of periodontal intrabony defects of stage-III periodontitis patients. Addition of I-PRF to DFDBA does not appear to significantly enhance the DFDBA’s reparative/regenerative outcomes. Clinical relevance: Within the current study’s limitations, routinely adding I-PRF to DFDBA cannot be recommended to significantly improve DFDBA’s treatment outcomes of in intrabony defects.