Periodontal Regenerative Therapy Using rhFGF-2 and Deproteinized Bovine Bone Mineral versus rhFGF-2 Alone: 4-Year Extended Follow-Up of a Randomized Controlled Trial

Abstract

The aim of this study was to evaluate longitudinal outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus deproteinized bovine bone mineral (DBBM) therapy in comparison with rhFGF-2 alone for treating periodontal intrabony defects. This study describes 4-year follow-up outcomes of the original randomized controlled trial. Intrabony defects in periodontitis patients were treated with rhFGF-2 (control) or rhFGF-2 plus DBBM (test). Clinical, radiographic, and patient-reported outcome (PRO) measures were used to evaluate the outcomes. Thirty-two sites were able to be followed up. At 4 years postoperatively, clinical attachment level (CAL) gains in the test and control groups were 3.5 ± 1.4 mm and 2.7 ± 1.4 mm, respectively, showing significant improvement from preoperative values but no difference between groups. Both groups showed an increase in radiographic bone fill (RBF) over time. At 4 years, the mean value for RBF in the test group (62%) was significantly greater than that in the control group (42%). In 1–2-wall defects, the test treatment yielded significantly greater RBF than the control treatment. No significant difference in PRO scores was noted between the groups. Although no significant difference in CAL gain was found between the groups at the 4-year follow-up, the combination treatment significantly enhanced RBF. Favorable clinical, radiographic outcomes, and PRO in both groups can be maintained for at least 4 years.

From Basic Science to Clinical Practice: A Review of Current Periodontal/Mucogingival Regenerative Biomaterials

“…Two possible scenarios arise in such cases: multiple sites in the same patient undergoing the same treatment or different ones. [ 67 , 70 , 85 , 93 , 101 , 113 , 116 , 124 , 129 , 132 , 139 , 154 ] Some clinical trials do not specify further how this randomization is performed. [ 81 , 94 , 147 , 233 ] This approach might introduce further complexities when interpreting the results, and it has been found that most trials in periodontology could benefit from better methodological and reporting quality.…”

“…[ 203 , 204 ] Clinical trials have extensively proven the efficacy of REGROTH Dental Kit, improving both clinical and radiographic outcomes. [ 129 , 139 , 164 , 201 , 205 , 206 ] Interestingly, the efficacy of rhFGF‐2 was not affected by patients’ age, sex, type of tooth, and classification of bone defects. [ 206 ] Moreover, in a randomized controlled clinical study on 2‐ and 3‐wall intra‐bony defects, REGROTH Dental Kit (Group 1) was found to be superior to Emdogain (Group 2) and OFD (Group 3) in radiographic bone fill after 36 weeks (Group 1: 34.37 ± 24.42%, Group 2: 23.29 ± 25.11%, Group 3: 13.30 ± 20.60%).…”

“…The available clinical trials have all demonstrated the safety of REGROTH Dental Kit. [ 129 , 139 , 164 , 201 , 205 , 206 ] However, care must be taken by clinicians since there is the possibility that applying the drug to a site containing tumour cells may promote their proliferation. [ 200 ]…”

Advances in Regenerative Dentistry Approaches: An Update

“… 24 In contrast, growth factors such as FGF-2, PDGF, and bone morphogenetic protein-2, in conjunction with various biomaterials, have also demonstrated improved clinical outcomes. 25 , 26 , 27 , 28…”

Advances Focusing on the Application of Decellularized Extracellular Matrix in Periodontal Regeneration

“…Soluble dECM is usually used in dental-derived dECM, such as porcine pulp dECM, dog periodontal membrane dECM, and even human dental capsule dECM. However, non-dental dECM, such as porcine SIS, acellular amnion, etc., needs to increase additional biological signals to promote periodontal regeneration, such as fibroblast growth factor [ 65 ], platelet fibrin [ 66 ], and other cytokines and mesenchymal stem cells, such as those related to periodontal regeneration, such as PDLSCs, BMSCs, DFSCs, ADSCs, and others [ 13 ].…”