Table 1. Prospective randomized clinical studies evaluating the efficacy of B-G and its variants in craniomaxillofacial bone reconstruction and oral surgery.
Title | Author | Journal | Scope | Patients and methods | Results | Conclusion |
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Using 45S5 Bioglass cones as endosseous ridge maintenance implants to prevent alveolar ridge resorption: a 5-year evaluation | Stanley et al | Int J Oral Maxillofac Implants 1997;12(1):95–105 | To examine the effectiveness of B-G 45S5 cones as space fillers after removal of tooth roots to delay the resorption of alveolar ridges | Retrospective review of 168 implants in 20 recalled patients with a mean postimplantation interval of 63.2 mo | High rate (85.7%) of cone retention after 5 y | Placement of B-G 45S5 into fresh sockets promoted alveolar ridge preservation |
Particulate bioglass as a grafting material in the treatment of periodontal intrabony defects | Zamet et al | J Clin Periodontol 1997;24(6):410–418 | To evaluate the effects of B-G 45S5 in the treatment of periodontal intrabony defects | Retrospective review of 20 patients. Clinical follow-up measurements were recorded at baseline, 3 mo and 1 y. Standardized radiographs for computer-assisted densitometric image analysis (CADIA) were taken at baseline, immediately postoperatively and at 1 y | CADIA data showed a significant increase in radiographic density and volume between the defects treated with B-G 45S5 when compared with those treated with surgical debridement only. Probing pocket depth and attachment level showed significant in sites treated with B-G 45S5 | Results demonstrated the efficiency of B-G 45S5 as an adjunct to conventional surgery in the treatment of intrabony defects |
Comparison of Bioactive glass synthetic bone graft particles and open debridement in the treatment of human periodontal defects. A clinical study | Froum et al | J Periodontol 1998;69(6):698–709 | To compare the repair response of B-G 45S5 and open debridement in the treatment of human periodontal osseous defects | Retrospective review of 16 patients. Radiographs and soft tissue presurgical measurements were repeated at 6, 9, and 12 mo. At 12 mo, all sites were surgically re-entered to record osseous measurements | Significantly greater mean probing depth reduction was noted, and clinical attachment level gain was significantly improved in the B-G 45S5 group compared with the controls. Also, there was significantly less gingival recession, and defect fill reduction was significantly greater in the B-G 45S5 sites compared with the control sites | B-G 45S5 showed significant improvements in clinical parameters compared with open flap debridement |
Clinical evaluation of bioactive glass in the treatment of periodontal osseous defects in humans | Lovelace et al | J Periodontol 1998;69(9):1027–1035 | To compare the use of B-G 45S5 to demineralized freeze-dried bone allograft (DFDBA) in the treatment of human periodontal osseous defects | Paired osseous defects in 15 patients with moderate to advanced adult periodontitis were randomly selected to receive grafts of B-G 45S5 or DFDBA. Clinical follow-up measurements were taken the day of surgery and at the 6-mo re-entry surgery | The results indicated that both treatments provided soft and hard tissue improvements when compared with baseline. No statistical difference was found when comparing sites grafted with B-G 45S5 to the use of DFDBA | This study showed that B-G 45S5 was capable of producing results in the short term (6 mo) similar to that of DFDBA when used in moderate to deep intrabony periodontal defects |
Alveolar ridge reconstruction and/or preservation using root form bioglass cones | Yilmaz et al | J Clin Periodontol 1998;25(10):832–839 | To investigate the efficacy of root form B-G 45S5 cones implanted extraction sites to avoid deformities of the residual alveolar ridge in the maxillary anterior region | Retrospective review of 16 patients. Alveolar ridge width and height measurements were obtained using study casts preoperatively, immediately postoperatively, and at 3 and 12 mo after operation | No dehiscences were detected. The differences between preoperative original ridge height and width and postoperative measurements were not statistically significant | Results demonstrated the efficiency of this method in preserving alveolar ridges following tooth extraction, particularly relevant in relation to preparation for subsequent restorative treatment |
A bioactive glass particulate in the treatment of molar furcation invasions | Anderegg et al | J Periodontol 1999;70(4):384–387 | To evaluate the effects of B-G 45S5 in the treatment of mandibular molar furcation invasion defects. Patients received surgical therapy using B-G 45S5 compared with open flap debridement alone | Retrospective review of 15 patients. Clinical follow-up measurements were recorded at 3 and 6 mo postoperatively | The results of therapy were statistically significant in the defects treated with B-G 45S5 | Results demonstrated the efficiency of B-G 45S5 in the treatment of class II furcation defects regarding the clinical parameters of probing depth reduction and the reduction in bleeding on probing |
Histological observations on biopsies harvested following sinus floor elevation using a bioactive glass material of narrow size range | Tadjoedin et al | Clin Oral Implants Res 2000;11(4):334–344 | To evaluate the bone augmenting capacity of B-G 45S5 particles in human sinus floor elevations | Retrospective review of 10 patients. Bilateral grafting was performed using a 1:1 mixture of autogenous bone particles (from iliac crest) and B-G 45S5 particles at one side (experimental side), and bone particles only at the other side (control side, split mouth design). Histomorphometrical measurements were repeated at 4, 6, and 16 mo from bone biopsies |
B-G 45S5 particles transformed and became excavated with time, starting at 4 mo, and their centers gradually filled with bone tissue. All B-G 45S5 particles had disappeared by resorption at 16 mo after grafting and had been replaced by bone tissue. Parameters of bone turnover indicated that bone remodeling was very active at both sides | Results demonstrated that a 1:1 mixture of autogenous bone/B-G 45S5 particles seemed a promising alternative to autogenous bone only, when low amounts of bone tissue are available for sinus augmentation |
Reconstruction of orbital floor fractures using bioactive glass | Kinnunen et al | J Craniomaxillofac Surg 2000;28(4):229–234 | To compare the use of B-G S53P4 implants with autogenous cartilage grafts for the repair of orbital floor defects after trauma | Retrospective review of 28 patients performed from 1995 to 1999. Clinical and radiological follow-up between 2 and 5 y after surgery | Postoperative tomograms showed adequate maintenance of orbital and maxillary sinus volume without any evidence of resorption or complications in either group | Bioactive glass implants were well tolerated and seemed to be a promising repair material for orbital floor fractures as well as the use of autologous bone alone. Their use provided favorable healing, caused new bone formation, and led to less morbidity as no donor-site operation was needed |
Clinical comparison of bioactive glass bone replacement graft material and expanded polytetrafluoroethylene barrier membrane in treating human mandibular molar class II furcations | Yukna et al | J Periodontol 2001;72(2):125–133 | To examine the response of mandibular molar class II furcations to treatment with either B-G 45S5 or expanded polytetrafluoroethylene (ePTFE) barrier membrane | Retrospective evaluation until surgical reentry at 6 mo in 27 pairs of mandibular molars in 27 patients with moderate to advanced periodontitis | Follow-up measurements demonstrated essentially similar clinical results with both treatments for bone and soft tissue changes | Equal clinical results with B-G 45S5 and ePTFE barriers. B-G 45S5 was associated with simpler application and required no additional material removal procedures |
Maxillary sinus floor augmentation using bioactive glass granules and autogenous bone with simultaneous implant placement | Cordioli et al | Clin Oral Implants Res 2001;12(3):270–278 | To evaluate the use of B-G 45S5 combined with autogenous bone (4:1 ratio) as grafting material for maxillary sinus augmentation with simultaneous implant placement | Unilateral or bilateral sinus augmentation was performed in 12 patients. Presurgical CT scans and core biopsy specimens were evaluated between 9 and 12 mo | An increase in mineralized tissue height of 7.1 ± 1.6 mm was evident when comparing the presurgical and 9–12 mo CT scans. Histological evaluation yielded a mean of 30.6 ± 5.7% of bone tissue in the grafted sites | B-G 45S5 with autologous bone graft used in one-stage sinus augmentation yielded sufficient quality and volume of mineralized tissue for predictable simultaneous implant placement in patients with 3–5 mm of bone height before grafting |
Effects of pretreatment clinical parameters on bioactive glass implantation in intrabony periodontal defects | Park et al | J Periodontol 2001;72(6):730–740 | To examine the effectiveness of B-G 45S5 implantation in intrabony periodontal defects | Retrospective evaluation 6 mo after surgery in 38 intrabony defects from 38 patients with chronic periodontitis | Comparative observation between preoperative and postoperative clinical parameters (probing depth, clinical attachment level, bone probing depth, and gingival recession) showed significantly greater improvements after B-G 45S5 implantation | Use of B-G 45S5 in flap operations resulted in significantly greater improvements over flap operation alone |
Repair of orbital floor fractures with bioactive glass implants | Aitasalo et al | J Oral Maxillofac Surg 2001;59(12):1390–1395; discussion 1395–1396 | To examine the effectiveness of B-G S53P4 implants for the repair of orbital floor defects caused by blunt facial trauma | Retrospective review of 36 patients performed from 1995 to 1999. Clinical and radiological follow-up at 1, 3, and 12 mo after surgery | No foreign body reaction and no inflammation in the bone or soft tissue. No sign of resorption or infection, nor postoperative extrusion, hemorrhage, or displacement. New bone formation around the implants. Good functional and cosmetic results at the 1-y follow-up | B-G S53P4 well-tolerated material in orbital floor reconstruction. It provided a favorable environment for an uncomplicated healing process |
Clinical evaluation of an enamel matrix protein derivative combined with a bioactive glass for the treatment of intrabony periodontal defects in humans | Sculean et al | J Periodontol 2002;73(4):401–408 | To compare the treatment of deep intrabony defects with a combination of enamel matrix protein derivative (EMD) and B-G 45S5 to B-G 45S5 alone | Retrospective review of 28 patients with chronic periodontitis. Soft tissue measurements (evaluation of probing depth, clinical attachment level, and gingival recession) were made at baseline and at 1 y following therapy | No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. At 1 y after therapy, no statistically significant differences in any of the investigated parameters were observed between the test and control groups | The combination of EMD and B-G 45S5 did not seem to additionally improve the clinical outcome of the therapy with B-G 45S5 alone |
Bioactive glass granules as a bone adjunctive material in maxillary sinus floor augmentation | Turunen et al | Clin Oral Implants Res 2004;15(2):135–141 | To compare the use of B-G S53P4 granules mixed with autologous bone (AB) chips harvested from the iliac crest (1:1 mixture) to bone alone in bilateral sinus floor augmentation procedure | Retrospective review of 17 patients. Biopsies for histological, scanning electron microscopy (SEM), and energy dispersive X-ray (EDX) analyses were taken after 21, 34, 49, and 62 wk | Histological evaluation and histomorphometrical analysis performed from the SEM images revealed similar results between the two groups. EDX analysis showed a tight contact and chemical bonding between the glass and bone | B-G S53P4 granules could be used together with AB chips as bone adjunctive material in maxillary sinus floor augmentation procedures, thus decreasing the amount of bone needed |
Bioactive glass S53P4 in frontal sinus obliteration: a long-term clinical experience | Peltola et al | Head Neck 2006;28(9):834–841 | To use B-G S53P4 as obliteration material in a series of osteoplastic frontal sinus operations on patients suffering from chronic frontal sinusitis | Retrospective review of 42 patients. Clinical and histopathologic follow-up at 1, 5, and 10 y after surgery | Histopathologic samples revealed bone formation. Fourier-transform infrared (FTIR) studies showed bone produced by B-G S53P4 to be similar to natural frontal bone. Microbiologic cultures obtained with histologic samples revealed no growth of bacteria | Accurate obliteration of sinuses achieved in 39 patients and uneventful recovery in 92% of the patients showed that B-G S53P4 was a reliable frontal sinus obliteration material, providing favorable conditions for total bony sinus obliteration |
Bioabsorbable membrane and bioactive glass in the treatment of intrabony defects in patients with generalized aggressive periodontitis: results of a 5-year clinical and radiological study | Mengel et al | J Periodontol 2006;77(10):1781–1787 | To compare the long-term effectiveness of bioabsorbable membrane Gore Resolut XT (RXT) (Gore Resolut® XT W.L. Gore & Associates Inc., Newark, DE) and B-G 45S5 in the treatment of intrabony defects in patients with generalized aggressive periodontitis | Clinical and radiological evaluation before surgery, at 6 mo and every year for 5 y after surgery of 16 patients: 22 intrabony defects treated with RXT and 20 treated with B-G 45S5 | Comparative observation of clinical parameters (plaque index, gingival index, probing depth, bleeding on probing, gingival recession, clinical attachment level, and tooth mobility) at baseline and every year for 5 y showed highly significant improvements with both groups | No significant difference between the use of RXT membrane and B-G 45S5 in the treatment of intrabony defects in patients with generalized aggressive periodontitis. Both regenerative materials gave good results in the treatment of intrabony periodontal defects |
Four-year results of a prospective-controlled clinical study evaluating healing of intrabony defects following treatment with an enamel matrix protein derivative alone or combined with a bioactive glass | Sculean et al | J Clin Periodontol 2007;34(6):507–513 | To evaluate the 4-y results following regenerative periodontal surgery at intrabony defects with either a combination of enamel matrix protein derivative (EMD) and B-G 45S5 or with EMD alone | Retrospective review of 25 patients randomly treated with either EMD or B-G 45S5, 13 treated with EMD alone (control). Measurements were recorded at baseline, at 1 and 4 y following therapy | Evaluation of clinical attachment level, probing depth, and gingival recession showed no statistically significant differences in any of the investigated parameters at 1 and 4 y between the treatment groups | Results indicated that the clinical improvements obtained with both regenerative modalities could be maintained over a period of 4 y |
Clinical evaluation of platelet-rich plasma and bioactive glass in the treatment of intra-bony defects | Demir et al | J Clin Periodontol 2007;34(8):709–715 | To evaluate the effect of B-G 45S5 with and without platelet-rich plasma (PRP) on the clinical healing of intrabony defects | Retrospective review of 29 patients. Intrabony defects were randomly treated with either PRP/B-G 45S5 or B-G 45S5 alone. Clinical parameters were recorded at baseline and repeated 9 mo after surgery and surgical re-entries were also performed |
Pocket depth reduction, clinical attachment gain, and defect fill were noted in both groups. None of the differences between the two treatment modalities were statistically significant | Results showed that both treatment modalities were effective in the treatment of intrabony defects. The results also showed that using PRP with B-G 45S5 has no additional benefit in the reduction of pocket depth, clinical attachment gain, and defect fill |
A cost-effectiveness evaluation of enamel matrix derivatives alone or in conjunction with regenerative devices in the treatment of periodontal intra-osseous defects | Listl et al | J Clin Periodontol 2010;37(10):920–927 | To identify the most cost-effective approach to treatment of infrabony lesions with enamel matrix derivatives (EMD) | Costs and clinical outcomes of 12 different treatment techniques (including flap operation, EMD alone, and EMD in association with B-G 45S5) were compared | The most cost-effective treatment option was identified on the basis of the maximum net benefit criterion. The maximum net benefit was achieved by treatment with EMD in conjunction with B-G 45S5 |
If EMD use is indicated, EMD in conjunction with either B-G 45S5 is more cost effective than EMD alone |
Comparison of bioactive glass coated and hydroxyapatite coated titanium dental implants in the human jaw bone | Mistry et al | Aust Dent J 2011;56(1):68–75 | To evaluate and compare the behavior of hydroxyapatite and B-G 45S5 coated implants (62 implants) in osseous tissue following implantation in 31 patients | B-G 45S5 coating was applied by vitreous enameling technique. The outcome was assessed up to 12 mo after prosthetic loading using different clinical and radiological parameters | B-G 45S5 coating materials were nontoxic and biocompatible. Overall results showed that B-G 45S5 coated implants were as equally successful as hydroxyapatite in achieving osseointegration and supporting final restorations | B-G 45S5 is a good alternative coating material for dental implants, possibly allowing wider case selection criteria together with improved integration rates even in the more challenging osteoporotic and medically compromised patients |
Autogenous cortical bone and bioactive glass grafting for treatment of intraosseous periodontal defects | Sumer et al | Eur J Dent 2013;7(1):6–14 | To compare the effectiveness of autogenous cortical bone (ACB) and B-G 45S5 grafting for the regenerative treatment of intraosseous periodontal defects | Via a split-mouth design, 15 chronic periodontitis patients who had probing pocket depths (PPDs) of ≥6 mm following initial periodontal therapy were randomly assigned to receive two treatments in contralateral areas of the dentition: ACB grafting and B-G 45S5 grafting. The parameters compared in the patients were preoperative and 6-month postoperative PPDs, clinical attachment levels (CALs), and radiographic alveolar bone heights | Both treatment modalities resulted in significant changes in postoperative measurements when compared with preoperative values. PPDs were decreased, CALs were increased, and radiographic alveolar bone heights were increased in patients treated with both ACB grafting and B-G 45S5 grafting. Differences between the treatments were not statistically significant | Both ACB and B-G 45S5 grafting led to significant improvements in clinical and radiographic parameters 6 mo postoperatively. These results suggest that either an ACB graft, which is completely safe with no associated concerns about disease transmission and immunogenic reactions, or a B-G 45S5 graft, which has an unlimited supply, can be selected for regenerative periodontal treatment |
Adipose stem cells used to reconstruct 13 cases with cranio-maxillofacial hard-tissue defects | Sándor et al | Stem Cells Transl Med 2014;3(4):530–540 | To examine the effectiveness of B-G 45S5 scaffolds seeded with adipose-derived stem cells (ASCs) for the repair of craniomaxillofacial hard-tissue defects. Autologous adipose tissue was harvested from the anterior abdominal wall, and adipose-derived stem cells were cultured, expanded, and then seeded onto resorbable scaffold materials for subsequent reimplantation into hard-tissue defects | Retrospective review of 13 patients. Hard-tissue defects at four anatomically different sites, namely, frontal sinus (3 cases), cranial bone (5 cases), mandible (3 cases), and nasal septum (2 cases). Follow-up time ranged from 12 to 52 mo |
Successful integration of the construct to the surrounding skeleton was noted in 10 of the 13 cases. Two cranial defect cases in which nonrigid resorbable containment meshes were used sustained bone resorption to the point that they required the procedure to be redone. One septal perforation case failed outright at 1 y because of the postsurgical resumption of the patient's uncontrolled nasal picking habit | Results indicated that the clinical improvements obtained with the use of (ASCs) seeded in B-G 45S5 scaffolds could be maintained over a period of 4 y |