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References Human Clinical Studies

Bioactive glass and bioabsorbable membrane in the treatment of a maxillary class II furcation defect: case report with 6-month re-entry.

Giusto TJ

The combination of bone graft materials with guided tissue regenerative procedures has been shown to have predictable positive results in periodontal defects, especially furcations. The following case report will demonstrate a severe class II furcation defect in a maxillary molar that was treated with combination therapy using bioactive glass and a bioabsorbable membrane made of a copolymer of polylactic/polyglycolic acid. Six-month re-entry revealed substantial clinical fill of the furcation defect. Comparison radiographs also demonstrated fill in the region

Compend Contin Educ Dent. 2005 Jan;26(1):41-2, 44, 46 passim; quiz 52-3.

Clinical evaluation of an enamel matrix protein derivative combined with a bioactive glass for the treatment of intrabony periodontal defects in humans.

Sculean A, Barbe G, Chiantella GC, Arweiler NB, Berakdar M, Brecx M.
Department of Periodontology and Conservative Dentistry, University of Saarland, Homburg, Germany.

BACKGROUND: The purpose of the present study was to compare the treatment of deep intrabony defects with a combination of an enamel matrix protein derivative (EMD) and a bioactive glass (BG) to BG alone. METHODS: Twenty-eight patients with chronic periodontitis, each of whom displayed 1 intrabony defect, were randomly treated with a combination of EMD and BG or with BG alone. Soft tissue measurements were made at baseline and at 1 year following therapy. RESULTS: No differences in any of the investigated parameters were observed at baseline between the 2 groups. Healing was uneventful in all patients. At 1 year after therapy, the sites treated with EMD and BG showed a reduction in mean probing depth (PD) from 8.07 +/- 1.14 mm to 3.92 +/- 0.73 mm and a change in mean clinical attachment level (CAL) from 9.64 +/- 1.59 mm to 6.42 +/- 1.08 mm (P < 0.0001). In the group treated with BG, the mean PD was reduced from 8.07 +/- 1.32 mm to 3.85 +/- 0.66 mm and the mean CAL changed from 9.78 +/- 1.71 mm to 6.71 +/- 1.89 mm (P < 0.0001). No statistically significant differences in any of the investigated parameters were observed between the test and control group. CONCLUSIONS: Within the limits of the present study, it can be concluded that both therapies led to significant improvements of the investigated clinical parameters, and the combination of enamel matrix derivative and bioactive glass does not seem to additionally improve the clinical outcome of the therapy.

J Periodontol 2002 Apr;73(4):401-8

Anti-inflammatory Effect of Bioactive Glass On Human Periodontal Intrabony Defects

Han J, Meng H, Xu Li, Chou L
Department of Periodontology, School of Stomatology, Peking University, Beijing 100081, P.R. China, Goldman School of Dental Medicine, Boston University, Boston, MA 02118, USA.

Bioactive glass (BAG) is a newer kind of alloplastic material. It has now been used in both orthopedic and plastic surgery applications to correct a variety of clinical situations involving osseous defects. A few studies have been published to date investigating the use of bioactive glass as a particular bone graft material in human periodontal bony defects. These studies indicate that bioactive glass has potential as a bone replacement graft material, handles satisfactorily and no adverse tissue reactions have been reported. Elastase (EA) that mainly originates from human polymorphonuclear leukocytes is one of the various biochemical components in gingival crevicular fluid (GCF). It was reported that elastase level decreased significantly after initial therapy or medicine treatment, which was correlated with the improvement of clinical conditions. However, whether the chagne of GCF-EA level after periodontal surgery is similar to non-surgery treatment and whether the changes of GCF amount and EA level after BAG graft are same as after simply open flap debridement are still unknown in our knowledge. The purpose of this study was to evaluate the anti-inflammatory effect of bioactive glass (BAG) on human periodontal intrabony defects. Gingival crevicular fluid (GCF) and elastase levels in gingival crevicular fluid (GCF-EA) in sites of intrabony defects were investigated in both with and without BAG grafting cases.

This study demonstrated that bioactive glass might have an effect on decreasing periodontal inflammation. Therefore, the material can be a useful adjunct to conventional surgery in the treatment of intrabony defects.

2002

Effects of pretreatment clinical parameters on bioactive glass implantation in intrabony periodontal defects.

Park JS, Suh JJ, Choi SH, Moon IS, Cho KS, Kim CK, Chai JK.
Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University, Seodaemun-gu, Seoul, Korea.

BACKGROUND: The various methods for regeneration of periodontal tissue that have been developed can be classified into guided tissue regeneration and bone implantation. Since the implantation materials have shown both deficiencies and merits, dentists have begun exploring the bioactive glass first used in plastic surgery. This paper examines the effectiveness of this new material on periodontal intrabony defects. METHODS: Clinical effects of bioactive glass implantation in intrabony periodontal defects were evaluated 6 months after surgery in 38 intrabony defects from 38 patients with chronic periodontitis. Twenty-one experimental defects received bioactive glass implantation (test group), while 17 control defects were treated with a flap procedure only (control group). The criteria for comparative observation were preoperative and postoperative probing depth (PD), clinical attachment level (CAL), bone probing depth (BPD), and gingival recession. RESULTS: Reductions in PD were observed in both groups (P<0.01). The reduction in PD was significantly greater in the test group when preoperative PD exceeded 7 mm (P<0.01). Improvements in CAL were also observed in both groups (P<0.01), with the test group showing significantly greater gains (P<0.05). In those cases where preoperative CAL was less than 7 mm, there was no statistically significant difference between the two groups. Reduction in BPD was observed in both groups, with the test group showing significantly greater reduction (P <0.01). There was no significant difference in BPD change, however, when preoperative BPD was < or =7 mm. Significantly greater reduction of BPD in the test group was observed when intrabony defect depth was >4 mm (P <0.05). Significant improvements in PD, CAL, and BPD were noted in the test group when the crestal involvement exceeded 100 degrees. Correlation test between various clinical parameters indicated that greater changes in PD and CAL in the test group were observed when preoperative CAL was large (P<0.001), and greater changes in PD (P<0.05), CAL (P<0.01), and BPD (P<0.05) were noted when preoperative BPD was large. Correlation between crestal involvement and CAL change was noted only in the control group (P<0.01). High correlations were observed between PD changes and CAL changes and between CAL changes and BPD changes in both groups. CONCLUSIONS: Use of a bone substitute in a flap operation resulted in significantly greater improvements in CAL and BPD over flap operation alone and seemed to have positive effects in postoperative PD, CAL, and BPD in those cases with more severe preoperative CAL and BPD.

J Periodontol 2001 Jun;72(6):730-40

Clinical comparison of bioactive glass bone replacement graft material and expanded polytetrafluoroethylene barrier membrane in treating human mandibular molar class II furcations.

Yukna RA, Evans GH, Aichelmann-Reidy MB, Mayer ET.
Department of Periodontics, Louisiana State University School of Dentistry, New Orleans, USA.

BACKGROUND: Class II furcations present difficult treatment problems and historically several treatment approaches to obtain furcation fill have been used. METHODS: The response of mandibular Class II facial furcations to treatment with either bioactive glass (PG) bone replacement graft material or expanded polytetrafluoroethylene (ePTFE) barrier membrane was evaluated in 27 pairs of mandibular molars in 27 patients with moderate to advanced periodontitis. Following initial preparation, full thickness flaps were raised in the area being treated, the bone and furcation defects debrided of granulomatous tissue, and the involved root surfaces mechanically prepared and chemically conditioned. By random allocation, PG or ePTFE was placed into or fitted over the furcations, packed or secured in place, and the host flap replaced or coronally positioned with sutures. Postsurgical deplaquing was performed every 10 days leading up to ePTFE removal at about 6 weeks. Continuing periodontal maintenance therapy was provided until surgical reentry at 6 months for documentation and any further necessary treatment. RESULTS: Direct clinical measurements demonstrated essentially similar clinical results with both treatments for bone and soft tissue changes. There were no statistically or clinically significant differences (e.g., mean horizontal furcation fill 1.4 mm PG, 1.3 mm ePTFE; mean percent horizontal furcation fill 31.6% PG, 31.1% ePTFE, both P>0.85). Seventeen of the PG treated and 18 of the ePTFE furcations became Class I clinically and 1 furcation completely closed clinically with each treatment. Intrapatient comparisons showed similar horizontal furcation responses with both treatments. CONCLUSION: The findings of this study suggest essentially equal clinical results with PG bone replacement graft material and e-PTFE barriers in mandibular molar Class II furcations. PG use was associated with simpler application and required no additional material removal procedures.

J Periodontol 2001 Feb;72(2):125-33

Bone Augmentation with Bioactive Ceramics before Insertion of Endosseous Dental Implants: Histories and Human Histology on Seventeen Consecutive Cases

Norton MR, Wilson J
78 Harley Street, London W1N 1AE, UK; Department of Materials, Imperial College, London, UK

Seventeen patients considered suitable for treatment with dental implants were referred to a private implant practice in London, UK. All patients required some bone grafting procedures for the repair of alveolar defects, prior to implantation. Bioactive ceramics were utilized as an alloplastic grafting material. Bone cores trephined out at the time of implantation were processed and examined to evaluate the tissue response. Connective tissue was seen to exist without any inflammatory response, for up to 6 months. Increasing evidence of bone formation was seen to exist in apposition to the ceramic material beyond this time frame. Response to the implants was assessed by radiographic and clinical examination. Results indicate that implants will integrate successfully in defects grafted with bioactive glass, with an overall success rate of 90%.

Key Engineering Materials Vols 192-195 (2001) pp 869-872
Proceedings of the 13th Int. Symp on Ceramics in Medicine, Bologna, Italy, 22-26 Nov (2000) pp 869-872

Gene-expression profiling of human osteoblasts following treatment with the ionic products of Bioglass 45S5 dissolution.

Xynos ID, Edgar AJ, Buttery LD, Hench LL, Polak JM.
Department of Histochemistry, Hammersmith Campus, Imperial College School of Science, Technology and Medicine, London, United Kingdom.

The effect of the ionic products of Bioglass 45S5 dissolution on the gene-expression profile of human osteoblasts was investigated by cDNA microarray analysis of 1,176 genes. Treatment with the ionic products of Bioglass 45S5 dissolution increased the levels of 60 transcripts twofold or more and reduced the levels of five transcripts to one-half or less than in control. Markedly up-regulated genes included RCL, a c-myc responsive growth related gene, cell cycle regulators such as G1/S specific cyclin D1, and apoptosis regulators including calpain and defender against cell death (DAD1). Other significantly up-regulated genes included the cell surface receptors CD44 and integrin beta1, and various extracellular matrix regulators including metalloproteinases-2 and -4 and their inhibitors TIMP-1 and TIMP-2. The identification of differentially expressed genes by cDNA microarray analysis has offered new insights into the mode of action of bioactive glasses and has proven to be an effective tool in evaluating their osteoproductive properties. Copyright 2001 John Wiley & Sons, Inc

J Biomed Mater Res 2001 May;55(2):151-7

Vertical Reconstruction of Horizontal Periodontal Defects Using a Bioactive Glass

Barbé G, Sculean A, Chiantella GC
Department de parodontologie et de dentisterie restauratrice, Universite de Saarland, Homburg, Allemagne
Exercice prive, Codigorro, Italie, Exercice prive, Reggio Calabria, Italie

The purpose of the present case report is to present the surgical procedure and the long term results following regenerative periodontal treatment of multiple horizontal defects with a bioactive glass particulate.

One patient presenting severe horizontal bone destruction localized at 3 mandibular incisors was treated with a bioactive glass. No post-operative complications occurred. An 80% reconstruction of the lost soft and hard tissues was observed at 1 year after surgery. The achieved results were maintained stable for 36 months.

Journal de parodontologie & d'implantologie orale Vol. 20 N 1/01 - pp 51 - 60

A bioactive glass particulate in the treatment of molar furcation invasions.

Anderegg CR, Alexander DC, Freidman M.
Oral Health Care Division, Block Drug Company, Inc., Jersey City, NJ, USA.

BACKGROUND: Procedures for the treatment of molar furcation invasion defects range from open flap debridement, apically repositioned flap, hemisection, tunneling or extraction, to regenerative therapies. METHODS: The results of surgical therapy consisting of the clinical parameters of probing depth and bleeding on probing were compared in 15 patients with moderate to advanced adult periodontitis. Each patient received surgical therapy consisting of regenerative therapy using bioactive glass compared to open flap debridement alone in human mandibular molar furcation defects. RESULTS: The results of therapy were statistically significant in the defects treated with the bioactive glass. CONCLUSIONS: This study revealed the benefits of bioactive glass in the treatment of Class II furcation defects regarding the clinical parameters of probing depth reduction and the reduction in bleeding on probing.

J Periodontol 1999 Apr;70(4):384-7

Reconstruction of orbital floor fractures using bioactive glass.

Kinnunen I, Aitasalo K, Pollonen M, Varpula M.
Department of Otorhinolaryngology-Head and Neck Surgery, Turku University Central Hospital, Finland.

INTRODUCTION: The management of orbital floor fractures continues to be debated. Bioactive glasses and glass-ceramics are in the new group of materials developed for the repair of bone defects which are beyond any innate healing capacity due to their size. OBJECTIVE: We compared the use of alloplastic implants (bioactive glass) with conventional autogenous grafts (cartilage--plus or minus Iyophilized dura) for the repair of orbital floor defects after trauma. MATERIAL AND METHODS: Twenty-eight patients having orbital floor fractures with persistent diplopia, enophthalmos, and/or infraorbital nerve paraesthesia were operated on from 1991 to 1995 at Turku University Central Hospital. Reconstruction was either with bioactive glass (S93P4) or autogenous cartilage implants. RESULTS: Postoperative tomograms in the 28 patients showed adequate maintenance of orbital and maxillary sinus volume without any evidence of resorption in either group. None of 14 patients in the study group had any evidence of dystopia or complications relating to implants follow-up. One had infraorbital nerve paraesthesia and another had entropion postoperatively. Among the 14 control subjects there were three cases of persistent diplopia, two of infraorbital nerve paraesthesia and one of enophthalmos. CONCLUSION: Bioactive glass implants are well-tolerated and seem to be a promising repair material for orbital floor fractures. Their use leads to less morbidity as no donor site operation is needed. Also it provides favourable healing as it is bioactive, biocompatible and causes new bone formation.

J Craniomaxillofac Surg 2000 Aug;28(4):229-34

Clinical evaluation of bioactive glass in the treatment of periodontal osseous defects in humans.

Lovelace TB, Mellonig JT, Meffert RM, Jones AA, Nummikoski PV, Cochran DL.

Department of Periodontics, The University of Texas Health Science Center at San Antonio, 78284-7894, USA.

The purpose of this study was to compare the use of bioactive glass to demineralized freeze-dried bone allograft (DFDBA) in the treatment of human periodontal osseous defects. Fifteen systemically healthy patients (6 males and 9 females, aged 30 to 63) with moderate to advanced adult periodontitis were selected for the study. All patients underwent initial therapy, which included scaling and root planing, oral hygiene instruction, and an occlusal adjustment when indicated, followed by re-evaluation 4 to 6 weeks later. Paired osseous defects in each subject were randomly selected to receive grafts of bioactive glass or DFDBA. Both soft and hard tissue measurements were taken the day of surgery (baseline) and at the 6-month re-entry surgery. The clinical examiner was calibrated and blinded to the surgical procedures, while the surgeon was masked to the clinical measurements. Statistical analysis was performed by using the paired Student's t test. The results indicated that probing depths were reduced by 3.07 +/- 0.80 mm with the bioactive glass and 2.60 +/- 1.40 mm with DFDBA. Sites grafted with bioactive glass resulted in 2.27 +/- 0.88 mm attachment level gain, while sites grafted with DFDBA had a 1.93 +/- 1.33 mm gain in attachment. Bioactive glass sites displayed 0.53 +/- 0.64 mm of crestal resorption and 2.73 mm bone fill. DFDBA-grafted sites experienced 0.80 +/- 0.56 mm of crestal resorption and 2.80 mm defect fill. The use of bioactive glass resulted in 61.8% bone fill and 73.33% defect resolution. DFDBA-grafted defects showed similar results, with 62.5% bone fill and 80.87% defect resolution. Both treatments provided soft and hard tissue improvements when compared to baseline (P < or = 0.0001). No statistical difference was found when comparing bioactive glass to DFDBA; however, studies with larger sample sizes may reveal true differences between the materials. This study suggests that bioactive glass is capable of producing results in the short term (6 months) similar to that of DFDBA when used in moderate to deep intrabony periodontal defects.

J Periodontol 1998 Sep;69(9):1027-35

Comparison of bioactive glass synthetic bone graft particles and open debridement in the treatment of human periodontal defects. A clinical study.

Froum SJ, Weinberg MA, Tarnow D.
New York University, Department of Implant Dentistry, New York, USA.

The purpose of this study was to compare the repair response of bioactive glass synthetic bone graft particles and open debridement in the treatment of human periodontal osseous defects. Fifty-nine defects in 16 healthy adults were selected. Each patient had at least 2 sites with attachment loss of at least 6 mm with clinical and radiographic evidence of intrabony or furcation defects. One to 3 months after cause-related therapy (oral hygiene instructions, scaling and root planing), the following measurements were recorded prior to surgery: probing depths, clinical attachment level, and gingival recession. Each defect was surgically exposed and measurements made of the alveolar crest height and base of osseous defect. The test defects were implanted with bioactive glass. The other sites served as unimplanted controls. Flaps were sutured at or close to the presurgical level. Radiographs and soft tissue presurgical measurements were repeated at 6, 9, and 12 months. At 12 months all sites were surgically re-entered to record osseous measurements. At the 12-month evaluation, significantly greater mean probing depth reduction was noted in the bioactive glass group compared to the controls (4.26 mm versus 3.44 mm; P = 0.028). Clinical attachment level gain was significantly improved (P = 0.0004) in the bioactive glass sites (2.96 mm) compared to the control sites (1.54 mm). There was significantly less gingival recession in the bioactive glass sites (1.29 mm) compared to the control sites (1.87 mm). Defect fill was significantly greater in the bioactive glass sites (3.28 mm) compared to the control sites (1.45 mm). Defect depth reduction was significantly greater in the bioactive glass sites (4.36 mm) compared to the control sites (3.15 mm). In conclusion, bioactive glass showed significant improvement in clinical parameters compared to open flap debridement.

J Periodontol 1998 Jun;69(6):698-709

Long-Term Evaluation of the Use of PerioGlas in Alveolar Ridge Augmentation Following Tooth Extraction: A Prospective Human Study

Kates JJ, Greskovich MS, Smith WK, Ariel DR, Diamond MW

Abstract: PerioGlas®, (Bioglass®) is a synthetic bone graft material that has been shown to be effective in filling extraction sites, repairing periodontal defects, and in augmentation of the alveolar ridge. The purpose of this study was to evaluate the short and long term safety and effectiveness of PerioGlas in maintaining alveolar ridge height following extraction of teeth.

A total of 22 sites were grafted in 17 patients. Follow-up time ranged from 8 to 48 months post-extraction. All patients treated with PerioGlas did not report any complications nor experience any post-operative inflammation at the surgical site. In addition, all surgical sites were clinically solid and adequately maintained the alveolar ridge over time.

Dental Cadmos, 1998

An evaluation of bioactive ceramic in the treatment of periodontal osseous defects.

Low SB, King CJ, Krieger J.
University of Florida College of Dentistry, Gainesville 32610-0434, USA.

Bioglass particulates were surgically placed in the periodontal osseous defects of 12 patients. The clinical parameters studied were probing depth, attachment level as measured with the Florida Probe, and standardized bitewing radiograph comparisons. Data was collected initially, and at 3-, 6-, and 24-month post-treatment intervals. Statistically significant improvements were demonstrated in all clinical parameters studied. There was a mean probing depth reduction of 3.33 mm, a mean attachment gain of 1.92 mm, and a mean radiographic bone fill of 3.47 mm. Results were stable over the 24-month period. Ease of handling and excellent tissue response were characteristic of the material.

Int J Periodontics Restorative Dent 1997 Aug;17(4):358-67

Behavior of Bioactive Glass (S53P4) in Human Frontal Sinus Obliteration

Aitasalo K, Suonpää J, Peltola M, Yli-Urpo A
Department of Otorhinolaryngology, Head and Neck Surgery, Turku University Central Hospital, FIN-20520 Turku, Finland, Institute of Dentistry, University of Turku, FIN-20520 Turku, Finland

A prospective study was carried out on bioactive glass (BG) as an obliteration material in a series of osteoplastic frontal sinus operations on 22 patients. Preoperative examinations and postoperative follow-ups included plain films, computed tomography (CT), magnetic resonance imaging (MRI) and laboratory monitoring. The follow-up visits were scheduled at 3, 6, 12 months and 2, 3 and 4 years. No complications related to the obliteration material were observed. All wounds healed well without signs of infection. The repair of defects filled with BG granules was closely monitored with repeated postoperative digital ROI selection of CT tomography image areas. Plain films and CT revealed no resorptive changes at the BG-bone interfaces. Contrast enhanced MRI indicated in-growth of fibrovascular tissue in spaces between the granules. ROI selection showed minor changes during the first year. Thereafter, the BG-bone interface remained stable. Two sinuses were explored one year postoperatively, and the retrieved specimens were evaluated histologically. The spaces between the BG granules were filled by fibrous tissue and in some areas by immature bone. The granules were partly incorporated with bone and with fibrous tissue. No inflammatory reactions, lymphocytes or granulocytes, were observed. All laboratory tests were within the normal range during follow-up. No infections were seen and no re-operations were necessary in our (22) obliteration cases.

Bioceramics, Vol 10, pg 429-432, Oct 1997

Clinical use of a bioactive glass particulate in the treatment of human osseous defects.

Shapoff CA, Alexander DC, Clark AE.
Block Drug Company, Jersey City, New Jersey, USA.

The dental practitioner has a wide choice of materials available for use in bone grafting procedures. A bioactive glass particulate possesses many favorable qualities not often found in other materials, including the ability to remain where placed even with adjacent suctioning; hemostasis; and incorporation into the host bone without the fibrous encapsulation encountered with most other synthetic materials. It is also quick and easy to prepare. This article reviews clinical experiences with PerioGlas in the setting of private practice periodontics, in which this material was used as the grafting material for periodontal defects, apicoectomies, cysts, and ridge augmentation and maintenance procedures, as well as for implant repairs. Several cases detail the advantages of this grafting material.

Compend Contin Educ Dent 1997 Apr;18(4):352-4, 356, 358 passim

Particulate bioglass as a grafting material in the treatment of periodontal intrabony defects.

Zamet JS, Darbar UR, Griffiths GS, Bulman JS, Bragger U, Burgin W, Newman HN.
Department of Periodontology, Eastman Dental Institute for Oral Health Care Sciences, University College London, UK.

The present clinical trial was designed to evaluate the effects of a bioactive glass, Perioglas, in the treatment of periodontal intrabony defects. 20 patients, 23-55 years of age (44 sites), with intrabony defects completed the 1-year study. Teeth with furcation involvement were excluded. After completion of initial therapy, defects were randomly assigned to either a test or control procedure. Following flap reflection, root planing and removal of chronic inflammatory tissue in both groups, the test defects were restored with the bioactive glass particulate material. Mucoperiosteal flaps were replaced, sutured and a periodontal dressing was used. All the patients received postoperative antibiotics and analgesics and were seen at 1 week for suture removal. Follow-up was then carried out weekly and at 3 months, 6 months, 9 months and 1 year post-surgery. Plaque score, bleeding score, probing pocket depth (PPD), probing attachment level (PAL) and gingival recession were recorded at baseline, 3 months and 1 year. Standardised radiographs for computer-assisted densitometric image analysis (CADIA) were taken at baseline, immediately post-operatively and at 1 year. The CADIA data showed a significant increase (F-ratio: 15.67, p < 0.001) in radiographic density and volume between the defects treated with the Perioglas when compared to those treated with surgical debridement only. PPD and PAL showed significant improvements in both experimental and control sites, with a greater trend to improvement in the experimental sites. It was concluded that this bioactive glass is effective as an adjunct to conventional surgery in the treatment of intrabony defects.

J Clin Periodontol 1997 Jun;24(6):410-8

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