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PubMed1985

[A newly devised chemo-embolic agent, G. T. XIII-ADM].

In order to bring about ideal chemotherapy, targeting, topical maintenance, sustained release and no side effects of the anticancer agent are essential. Adriamycin (ADM) was immobilized on absorbable gelatin material (G) together with thrombin (T) and factor XIII (XIII) to form such an agent, "G . T . XIII-ADM". The material was applied as an embolic agent in experimental transcatheter arterial chemo-embolization (TACE) in rabbits with VX2-carcinoma. Response rate of the tumor (CR + PR) was 75% for "G . T . XIII-ADM", and 28.6% for intra-arterial infusion (IA) of ADM. The ADM was maintained for a long period both in the tumors and the metastatic lymph nodes, in the animals given the chemo-embolic agent. The materials were then clinically prescribed as an embolic agent in preoperative TACE for patients with locally advanced breast cancer. The oncolytic effects obtained with the "G . T . XIII-ADM" were remarkably favorable and the side effects were almost nil. These positive data suggest that "G . T . XIII-ADM" has great potential as a new approach to cancer chemotherapy.

Animals↗
PubMed1998

Viscosities of implantable biomaterials in vocal fold augmentation surgery.

Vocal fold vibration depends critically on the viscoelasticity of vocal fold tissues. For instance, phonation threshold pressure, a measure of the "ease" of phonation, has been shown to be directly related to the viscosity of the vibrating mucosa. Various implantable biomaterials have been used in vocal fold augmentation surgery, with implantation sites sometimes close to or inside the mucosa. Yet their viscosities or other mechanical properties are seldom known. This study attempts to provide data on viscosities of commonly used phonosurgical biomaterials. Using a parallel-plate rotational rheometer, oscillatory shear experiments were performed on implantable polytetrafluoroethylene (Teflon or Polytef; Mentor Inc., Hingham, MA), collagen (Zyderm; Collagen Corp., Palo Alto, CA), glutaraldehyde crosslinked (GAX) collagen (Phonagel or Zyplast; Collagen Corp.), absorbable gelatin (Gelfoam; Upjohn Co., Kalamazoo, MI), and human abdominal subcutaneous fat. Samples of human vocal fold mucosal tissues were also tested. Under sinusoidal oscillatory shear at 10 Hz and at 37 degrees C, the dynamic viscosity was 116 Pascal-seconds (Pa-s) for polytetrafluoroethylene, 21 Pa-s for gelatin, 8-13 Pa-s for the two types of collagen, 3 Pa-s for fat, and 1 to 3 Pa-s for vocal fold mucosa. Results extrapolated to 100 Hz also show similar differences among the biomaterials, but all values are an order of magnitude lower because of the typical inverse frequency relation (shear thinning effect) for polymeric and biologic materials. The data suggest that the use of fat for vocal fold augmentation may be more conducive to the "ease" of phonation because of its relatively low viscosity, which is closest to physiologic levels. This implication is probably the most relevant in predicting initial outcome of the postoperative voice before there is any significant assimilation (e.g., resorption and fibrosis) of the implanted biomaterial.

Abdomen↗
PubMedDate not supplied

Bone formation and reosseointegration in peri-implantitis defects following surgical implantation of rhBMP-2.

This study was designed to evaluate bone formation and reosseointegration following surgical implantation of recombinant human bone morphogenetic protein-2 (rhBMP-2) in peri-implantitis defects. Hydroxyapatite-coated dental implants were placed bilaterally in the mandibular and maxillary premolar area in four rhesus monkeys and were allowed to osseointegrate for 1 year. Cotton ligatures were then placed around the healing abutments, and plaque was allowed to accumulate for 11 months. Resulting circumferential peri-implantitis defects exhibited a large intrabony and horizontal component. At reconstructive surgery, peri-implantitis defects in contralateral jaw quadrants were randomly assigned to receive rhBMP-2 (0.43 mg/mL implant volume) in an absorbable collagen sponge carrier or a carrier control. The animals were sacrificed 4 months postsurgery, and block sections were prepared for histometric analysis. Summary statistics included means calculated per animal. Paired t tests were used to evaluate differences between experimental conditions (n = 4). Defect depth amounted to 3.4 +/- 0.9 mm and 3.2 +/- 0.9 mm for rhBMP-2 and control defects, respectively. Vertical bone gain in rhBMP-2 defects (2.6 +/- 1.2 mm) was significantly greater than in controls (0.8 +/- 0.8 mm; P < .01). Reosseointegration within the confines of the defect for rhBMP-2 defects (29.0 +/- 10.5%) differed significantly from that in the control (3.5 +/- 2.5%; P < .01). Reosseointegration within the extent of newly formed bone averaged 40.0 +/- 11.0% in rhBMP-2 defects as compared to 8.9 +/- 7.8% in the control (P < .01). Osseointegration in resident bone amounted to 69.5 +/- 6.9% and 72.6 +/- 8.0% for rhBMP-2 and control defects, respectively. There is significant evidence that rhBMP-2 has potential to promote bone formation and reosseointegration in advanced peri-implantitis defects in a demanding nonhuman primate model.

Alveolar Bone Loss↗
PubMed1993

An experimental study and clinical pilot trials on yttrium-90 glass microspheres through the hepatic artery for treatment of primary liver cancer.

BACKGROUND: Yttrium-90 (90-Y) glass microsphere is a new kind of radiation microsphere for internal radiation therapy of primary liver cancer (PLC). The study was carried out by administration of 35 microns nondegradable 90-Y glass microsphere through the hepatic artery for treatment of PLC. METHODS: Six rabbits were injected with 185-1480 megabecquerels (MBq) of 90-Y glass microspheres, and three rabbits were injected with 35-300 mg of 89-Y glass microspheres for the toxic test. Eighteen patients received 2442-5550 MBq of 90-Y glass microspheres for the treatment of PLC. Whole blood counts, liver function, and imaging examination were performed. Pathologic examinations were performed on all rabbits. RESULTS: All rabbits were apparently well after absorbing 114.1-845.2 Gy 90-Y glass microspheres in the liver but showed transient degeneration of hepatocytes and portal fibrosis histologically. The mean absorbed dose in liver tissue of patients with PLC was 30.33 Gy, whereas that in tumor tissue was 88 Gy and the highest in tumor tissue, 186.36 Gy. The mean tumor:liver tissue ratio was 3:1; the highest, 14:1. Fourteen patients were still alive after half a year's follow-up and 6 of these 14 were still alive after 1 year. CONCLUSIONS: The rabbits could tolerate up to eight-fold of the upper limit of clinical dose (100 Gy). Good responses to the radiation therapy of 90-Y glass microspheres in patients with localized and hypervascular or vascular mass were achieved. Contraindications for the therapy were presence of massive hepatic arterioportal shunt and cancer emboli in the main portal vein. It is safe and applicable to deliver 90-Y glass microspheres in large doses through the hepatic artery for internal radiation treatment of PLC.

Adult↗
PubMed2005

Analysis of rat calvaria defects implanted with a platelet-rich plasma preparation: radiographic observations.

BACKGROUND: Platelet-rich plasma (PRP) harbors growth factors identified in bone. It has been suggested that these factors enhance osteogenesis. The objective of this study was to conduct a radiographic evaluation on local bone formation following surgical implantation of a PRP preparation using a critical-size rat calvaria defect model. METHODS: Thirty 22-week-old male Sprague-Dawley rats were used. The PRP preparation was obtained from 10 ml of whole blood drawn from one age-matched donor rat. The preparation was processed by gradient density centrifugation and stored at -80 degrees C until use. Using aseptic techniques, the PRP preparation soak-loaded onto an absorbable collagen sponge (ACS) carrier or ACS alone was surgically implanted into contralateral critical-size 6 mm rat calvaria osteotomies in 18 animals. Twelve animals received ACS alone versus sham surgery in contralateral defects. Animals were sacrificed at 4 and 8 weeks when biopsies were collected and radiographs were obtained using a standardized protocol. Three masked examiners independently evaluated the radiographic images of the defect sites. Examiner reproducibility was examined by repeat evaluation of all defect sites (r=0.6; P <0.0001). RESULTS: The animals were maintained without adverse events. Defect sites in two animals receiving ACS versus sham surgery (4-week healing interval) were not evaluated due to specimen damage. Seventy-five percent of the sites (PRP/ACS or ACS) exhibited partial closure at 4 weeks; one site (ACS) exhibited full closure without significant differences between protocols (P=0.1797). Fifty percent of the sites receiving PRP/ACS exhibited full closure and 20% partial closure at 8 weeks versus 20% and 80%, respectively, for the ACS control (P=0.7532). There were no noteworthy differences between sites receiving ACS versus sham surgery at 4 or 8 weeks. CONCLUSION: The results suggest that the PRP preparation does not have a significant effect on osteogenesis.

Animals↗
PubMedDate not supplied

Osseointegration of dental implants complexed with rhBMP-2: a comparative histomorphometric and radiographic evaluation.

PURPOSE: To evaluate the effect of rhBMP-2 on implant osseointegration using histomorphometric and radiographic imaging analyses and determine the diagnostic accuracy of periapical radiographs regarding clinical bone-implant contact levels. MATERIALS AND METHODS: Hollow-cylinder implants were filled with an absorbable collagen sponge soaked with recombinant human bone morphogenetic protein-2 (rhBMP-2) or left empty and implanted in the mandibles of dogs. Animals were followed for 2, 4, 8, or 12 weeks. At the end of each time interval, the animals were sacrificed and specimens were collected for histomorphometric and radiographic evaluation of the bone-implant contact levels. RESULTS: Both groups exhibited the same mean histologic bone-implant contact on the outer surface of the implant, except for the 4-week group. The radiographic evaluation of bone-implant contact overestimated the actual osseointegration levels by at least 30%, a significant amount. DISCUSSION: The osteoinductive and regenerative potential of rhBMP-2 is of clinical benefit in cases where bone augmentation is indicated and improved levels of osseointegration are expected. Radiographic evaluation has been the most widely employed technique in clinical practice for assessing bone levels around dental implants and comparing changes over time. However, there is a limit to the diagnostic accuracy of conventional radiographs when compared to the data obtained by histologic analysis. CONCLUSION: Application of rhBMP-2 within the confined boundaries of the hollow chamber of the implant had a limited effect on the osseointegration level along its outer surface, perhaps because of physically restricted diffusion. Radiographic evaluation resulted in the overestimation of bone-implant contact, and poor correlation with the histomorphometric data was found.

Animals↗
PubMed2004

Effect of recombinant human bone morphogenetic protein-4 dose on bone formation in a rat calvarial defect model.

BACKGROUND: Bone morphogenetic proteins (BMPs) are being evaluated for periodontal and bone regenerative therapy. The objective of this study was to evaluate the effect of recombinant human bone morphogenetic protein-4 (rhBMP-4) dose on local bone formation in a rat calvaria defect model. METHODS: Calvarial, 8 mm diameter, critical-size osteotomy defects were created in 140 male Sprague-Dawley rats. Seven groups of 20 animals each received either 1) rhBMP-4 (2.5 microg) in an absorbable collagen sponge (ACS) carrier, 2) rhBMP-4 (5 microg)/ACS, 3) rhBMP-4 (2.5 microg) in a beta-tricalcium phosphate (beta-TCP) carrier, 4) rhBMP-4 (5 microg)/beta-TCP, 5) ACS or 6) beta-TCP carrier controls, or 7) a sham-surgery control, and were evaluated by histologic and histometric parameters following a 2- or 8-week healing interval (10 animals/group/healing interval). RESULTS: Surgical implantation of rhBMP-4/ACS and rhBMP-4/beta-TCP resulted in enhanced local bone formation at both 2 and 8 weeks. Within the dose range examined, rhBMP-4 did not exhibit an appreciable dose-dependent response. Defect closure was not significantly different between the rhBMP-4/ACS and rhBMP-4/beta-TCP groups. New bone area of the rhBMP-4/ beta-TCP group was significantly greater than that of the rhBMP-4/ ACS group; however, bone density in the rhBMP-4/ACS group was significantly greater than that in the rhBMP-4/beta-TCP group at 8 weeks (P < 0.05). CONCLUSIONS: rhBMP-4 combined with ACS or beta-TCP has a significant potential to induce bone formation in the rat calvaria defect model. Within the selected rhBMP-4 dose range and observation interval, there appeared to be no meaningful differences in bone formation.

Animals↗
PubMedDate not supplied

Bone formation and osseointegration stimulated by rhBMP-2 following subantral augmentation procedures in nonhuman primates.

The purpose of this study was to evaluate bone formation and osseointegration using titanium dental implants in the subantral space following surgical implantation of recombinant human bone morphogenetic protein-2 (rhBMP-2). In each of four cynomolgus monkeys, one subantral site was treated with rhBMP-2 (0.19 mg per implant) in an absorbable collagen sponge (ACS). The contralateral site was treated with vehicle in ACS (control). Three months later, two screw-type titanium dental implants were placed into each augmented sinus, and one additional implant was placed immediately anterior to the sinus. Thus, each animal had three experimental sites: rhBMP-2, control, and nonsinus. Animals were sacrificed after an additional 3 months, and block sections were harvested and prepared for histometric analysis. Analysis of variance and t tests were used to evaluate differences between experimental conditions. Mean (+/- SD) vertical bone gain was significantly greater in rhBMP-2 than in control sites (6.0 +/- 0.3 versus 2.6 +/- 0.3 mm; P < .002). Bone density in rhBMP-2 sites averaged 14.4 +/- 2.9% versus 13.9 +/- 4.6% and 14.1 +/- 3.6% for control and nonsinus sites, respectively, without significant differences between experimental conditions. Bone-implant contact in rhBMP-2 sites (41.4 +/- 7.7%) was not significantly different from that in control (38.9 +/- 12.4%) and nonsinus sites (46.8 +/- 10.6%). The present study provides evidence for considerable vertical bone gain in the subantral space following surgical implantation of rhBMP-2, thus allowing placement of dental implants. The newly formed bone appears to be of similar quality and to be as suitable for osseointegration as the residual bone in this nonhuman primate model. Thus, surgical implantation of rhBMP-2 appears to have clinical utility and may provide a realistic alternative to autogenous bone grafts for subantral augmentation procedures.

Analysis of Variance↗
PubMed2002

Effect of recombinant human bone morphogenetic protein-2/absorbable collagen sponge (rhBMP-2/ACS) on healing in 3-wall intrabony defects in dogs.

BACKGROUND: Recombinant human bone morphogenetic protein-2 (rhBMP-2) in an absorbable collagen sponge (ACS) carrier is being evaluated as a candidate therapy for periodontal regeneration. The objective of this study was to evaluate regeneration of alveolar bone and cementum, and associated root resorption and ankylosis following surgical implantation of rhBMP-2/ACS in a canine clinical model. METHODS: Bilateral 3-wall intrabony periodontal defects were surgically induced in the premolar region in the maxilla and mandible in 8 young adult Korean mongrel dogs. The defects in each animal received rhBMP-2/ACS (rhBMP-2 at 0.2 mg/ml, total implant volume/defect approximately 0.1 ml) or buffer/ACS, or served as sham-operated controls. Surgeries were sequenced for each animal to provide postmortem observations following 8- and 24-week healing intervals. Treatment outcomes were evaluated using clinical, radiographic, and histometric parameters. RESULTS: Surgical implantation of rhBMP-2/ACS resulted in accelerated enhanced bone formation in the 3-wall intrabony periodontal defects but in no apparent enhancement of cementum regeneration. rhBMP-2/ACS did not appear to be associated with aberrant healing events such as root resorption and ankylosis under these simulated clinical conditions. CONCLUSIONS: Surgical implantation of rhBMP-2/ACS may be used safely to support regeneration of alveolar bone in intrabony periodontal defects in dogs without aberrant events such as root resorption or ankylosis complicating the regenerative procedure. rhBMP-2/ACS does not appear to have a significant effect on cementum regeneration and formation of a functional periodontal ligament in this model.

Alveolar Bone Loss↗
PubMed1990

Chemoembolization for hepatocellular carcinoma.

Fifty-one patients with unresectable hepatocellular carcinoma (HCC) were treated with Gelfoam (absorbable gelatin sterile powder; The Upjohn Co, Kalamazoo, MI) chemoembolization. A mixture of Gelfoam powder, contrast media, and three drugs (doxorubicin, mitomycin, and cisplatin) was injected under fluoroscopic guidance via a percutaneous catheter into the hepatic artery until stagnation of blood flow was achieved. Of the 51 patients, 50 are assessable for response, and all are assessable for toxicity and complications. The median percent of liver replacement was 50% (range, 15% to 95%). By conventional response criteria, there were 12 partial responses (PRs) (24%), 13 minor responses (MRs) (26%), 12 stabilization of disease (SD) (24%), and 13 (26%) progressive disease (PD). Tumor liquefaction was noted on computed tomographic (CT) scan in 35 of 50 patients (70%). Of the 34 patients with elevated alpha-fetoprotein (AFP), 23 (68%) had a greater than 50% reduction following treatment. Responding patients were re-treated at the time of tumor progression if they still met the entry criteria. The median survival of assessable patients from the time of treatment was 207 days and from the diagnosis of the primary was 302 days. Fourteen patients remain alive at 3 months to 3 years following treatment. The vast majority of patients had transient pain, fever, nausea, and elevation in liver enzymes. Ascites developed in 14 patients. There were two treatment-related deaths: one from tumor hemorrhage and one from liver failure. Chemoembolization appears to have significant activity in patients with hepatocellular carcinoma and is relatively well tolerated.

Adolescent↗
PubMed2003

Effect of recombinant human bone morphogenetic protein-4 with carriers in rat calvarial defects.

BACKGROUND: Bone morphogenetic proteins (BMPs) are being evaluated as candidates for periodontal and bone regenerative therapy. However, the research on recombinant human bone morphogenetic protein-4 (rhBMP-4) has been insufficient to evaluate its capacity to enhance bone formation and its carrier system. The purpose of this study was to evaluate the bone regenerative effect of rhBMP-4 delivered with an absorbable collagen sponge (ACS) or beta-tricalcium phosphate (beta-TCP). We also compared the potential of beta-TCP to that of ACS as a carrier system for rhBMP-4. METHODS: Eight-mm calvarial critical-sized defects were created in 100 male Sprague-Dawley rats. The animals were divided into 5 groups of 20 animals each. The defects were treated with rhBMP-4/ACS (rhBMP-4 at 0.05 mg/ml), rhBMP-4/beta-TCP (rhBMP-4 at 0.05 mg/ml), ACS alone, beta-TCP alone, or left untreated for surgical control. The rats were sacrificed at 2 or 8 weeks postsurgery, and the results were evaluated radiodensitometrically, histologically, and histomorphometrically. RESULTS: The results of radiodensitometric analysis were as follows: the rhBMP-4/ACS and the rhBMP-4/beta-TCP groups were more radiopaque than other groups at both 2 and 8 weeks (P < 0.01). The histologic observations were as follows: in the rhBMP-4/ACS and the rhBMP-4/beta-TCP groups, new bone was evident at the defect sites at 2 weeks and 8 weeks. The results of histomorphometric analysis were as follows: the rhBMP-4/ACS and the rhBMP-4/beta-TCP groups had more bone (%) than other groups at both 2 and 8 weeks (P < 0.01). CONCLUSIONS: Surgical implantation of rhBMP-4/ACS may be used to support bone regeneration in the rat calvarial critical-sized defect, and rhBMP-4/beta-TCP may be able to regenerate bone in the rat calvarial critical-sized defect without complication. In addition, both ACS and beta-TCP may be considered as available carriers for rhBMP-4.

Absorptiometry, Photon↗
PubMed2004

Effect of recombinant human bone morphogenetic protein-2 in an absorbable collagen sponge with space-providing biomaterials on the augmentation of chronic alveolar ridge defects.

BACKGROUND: Recombinant human bone morphogenetic protein-2 (rhBMP-2) in an absorbable collagen sponge (ACS) carrier has been shown to support significant bone formation in the craniofacial skeleton. When used as an onlay, however, rhBMP-2/ACS may become compressed with limited resulting bone formation. The objective of this study was to evaluate the effect of two space-providing biomaterials, bioactive glass (BG) and demineralized/mineralized bone matrix (DMB), on rhBMP-2/ACS induced alveolar ridge augmentation. METHODS: Bilateral alveolar ridge defects were produced in the mandible in six mongrel dogs. rhBMP-2/ACS with biomaterials was surgically implanted into contralateral defects in four animals. Treatments were alternated between jaw quadrants in consecutive animals. Two animals received rhBMP-2/ACS or sham-surgery in contralateral defects. The animals were injected with fluorescent bone labels to monitor bone formation. Clinical evaluations were made at ridge augmentation and 12 weeks post-implantation when the animals were euthanized and block biopsies collected for histopathologic evaluation. RESULTS: Sham-surgery produced limited horizontal alveolar augmentation (0.1 +/- 0.6 mm). Implantation of rhBMP-2/ACS resulted in alveolar augmentation amounting to 2.2 +/- 1.8 mm. Alveolar augmentation in sites receiving rhBMP-2/ACS with DMB or BG was 2-fold greater compared to rhBMP-2/ACS alone averaging 4.4 +/- 1.3 and 4.6 +/- 1.5 mm, respectively. The DMB biomaterial appeared substituted by newly formed bone. The BG particles were observed imbedded in bone or encapsulated in dense connective tissue without associated bone metabolic activity. Fluorescent light microscopy suggested that the new bone was formed within 4 weeks. CONCLUSION: The bioglass and demineralized/mineralized bone matrix biomaterials utilized in this study in combination with rhBMP-2/ACS supported clinical and histological ridge augmentation.

Alveolar Bone Loss↗
PubMedDate not supplied

Effects of topically applied biomaterials on paranasal sinus mucosal healing.

BACKGROUND: Recently, nasal packing made of absorbable biomaterial has become increasingly popular. Although absorbable packs are effective for hemostasis, their impact on healing mucosa is unknown. Some have felt that a biocompatible sinus dressing actually may enhance healing, particularly in areas where the mucosa has been stripped. The aim of this study was to determine the effect of topical MeroGel and FloSeal on paranasal sinus mucosal healing in a rabbit model. METHODS: Bilateral maxillary sinuses of 12 New Zealand white rabbits were surgically opened and stripped of mucosa. The left maxillary sinus of six rabbits had sterile saline-soaked MeroGel placed in the antrum, and the other six rabbits received FloSeal. The right maxillary sinuses of all 12 animals were stripped and otherwise untreated to serve as stripped controls. The animals were killed at 2 weeks and specimens were examined by light microscopy. RESULTS: MeroGel-treated mucosa showed extensive fibrosis of the basal lamina and lamina propria, complete loss of surface epithelium, and loss of the mucociliary blanket. There was minimal resorption of the MeroGel, and MeroGel fibers were frankly incorporated into the regenerated epithelium, associated with an exuberant lymphocytic infiltrate. FloSeal-treated mucosa showed similar fibrosis of the basal lamina and lamina propria with loss of the mucociliary blanket, although to a lesser degree than the MeroGel- treated group. FloSeal showed similar incorporation into the healed mucosa with lymphocytosis. Controls showed expected submucosal gland reduction, lamina propria fibrosis, and loss of cilia, but the lamina propria fibrosis seen in the MeroGel and FloSeal groups was markedly more prominent. CONCLUSION: In a rabbit model, MeroGel and FloSeal appear to increase reactionary fibrosis of healing mucosa. These agents also appear to be incompletely resorbed and grossly incorporated into healing tissue. Mucosal healing may be impaired by the application of these agents.

Administration, Topical↗
PubMed2000

Evaluation of recombinant human bone morphogenetic protein-2 in oral applications including the use of endosseous implants: 3-year results of a pilot study in humans.

BACKGROUND: This study evaluated patients who had been treated with recombinant human bone morphogenetic protein-2 (rhBMP-2) loaded in an absorbable collagen sponge (ACS) in human extraction sites or in sites that required alveolar ridge augmentation. An earlier report on the same patients revealed that after 4 months, implantation of rhBMP-2/ACS was safe, as determined by clinical, radiographic, systemic, and immunological analyses. In this longer-term follow-up, eligible patients were restored with endosseous dental implants in the area treated with rhBMP-2/ACS and bone biopsy samples were taken for histological analysis of the treated human bone tissue. The primary objective was to monitor the long-term safety of patients treated with rhBMP-2/ACS. Another objective was to evaluate the dental implants placed in the sites treated with rhBMP-2. METHODS: Patient safety was evaluated by clinical examinations, periapical radiographs, and occurrence of adverse experiences. Dental implants were evaluated by radiographic and clinical examination. All 12 patients have been followed for 3 years. RESULTS: Two years following surgical implantation of rhBMP-2/ACS, no serious or unexpected adverse experiences occurred. The adverse experiences that did occur were mostly benign and compatible with the dental implant surgeries performed in these patients. No adverse experiences were deemed as related to the rhBMP-2/ACS. Furthermore, no safety concerns in the local area of rhBMP-2/ACS placement were noted, based on oral wound examinations. In the 10 patients (6 extraction socket patients and 4 augmentation patients) who received endosseous implants, all implants were clinically stable at all assessments and all 10 patients have been functionally restored. Histological evaluation of the human bone core biopsies revealed normal bone tissue formation identical to the surrounding native bone. Three-year follow-up clinical examinations revealed that all implants had stable marginal bone levels and healthy peri-implant tissues. CONCLUSIONS: These 3-year results demonstrate that rhBMP-2/ACS can be used safely in human patients. Human bone biopsies reveal normal bone formation in areas treated with rhBMP-2/ACS. Endosseous implants placed in these areas were all stable with no radiographic or clinical complications. The results from this study suggest that rhBMP-2/ACS (0.43 mg/ml) can be safely used in tooth extraction sites and in local ridge augmentation procedures and that endosseous dental implants placed in bony areas treated with rhBMP-2/ACS are stable and can be functionally restored without complication.

Alveolar Process↗
PubMed2002

Comparative study of the efficacy of the common topical hemostatic agents with fibrin sealant in a rabbit aortic anastomosis model.

OBJECTIVE: The purpose of this study was to compare the hemostatic efficacy of the common surgical hemostatic agents with fibrin sealant (FS) and to assess their functional strength to secure hemostasis in lieu of placing additional sutures. METHODS: End-to-end anastomosis of transected abdominal aorta was performed in moderately anticoagulated rabbits using 4 or 6 interrupted sutures. The suture line was covered either with gauze alone ("untreated") or with gauze plus Gelfoam, Avitene, Surgicel, FloSeal, or FS, following which blood flow was restored. Blood loss was absorbed by gauze and measured. The surviving rabbits were recovered and the repaired vessel was examined histologically 4 weeks after operation. The investigators were blinded to the treatment groups. Aortic anastomoses using 8 or 12 sutures (untreated) were also performed. RESULTS: Untreated 4-suture anastomosis of aorta resulted in a profuse hemorrhage with an average 108.0 +/- 19.2 (mean +/- SD) ml blood loss and 100% mortality (n = 4). FS application sealed the anastomoses, prevented blood loss (P < 0.01 vs untreated) and exsanguination of the rabbits (n = 4). Other hemostatic agents reduced the bleeding to varying degrees compared to the untreated animals (Gelfoam 66.4 +/- 17.6, Avitene 80.6 +/- 34, Surgicel 66.7 +/- 16.7, FloSeal 44.2 +/- 8.5 ml blood loss, n = 4/group), but the changes were not statistically significant. One to three rabbits in each group survived the operation. Six-suture aortic anastomoses, untreated, resulted in 67.7 +/- 21.8 ml blood loss and 100% survival (n = 6). Application of FS produced immediate and sustained hemostasis in all the animals (P < 0.01 vs untreated). Other hemostatic agents also reduced the bleeding (Gelfoam 42.5 +/- 10, Avitene 50.9 +/- 12.4, Surgicel 32.1 +/- 14, FloSeal 33.9 +/- 5.4 ml blood loss, n = 6/group), but the changes were not statistically significant. The 8- and 12-suture aorta repairs resulted in a moderate blood loss (43.9 +/- 19 and 21.3 +/- 14.9 ml, respectively), followed by a stable hemostasis that precluded the need to use any hemostatic agent. The aortic cross-clamping time of the 12-suture and time to hemostasis for both the 8- and the 12-suture techniques were significantly longer than those of the 4-suture plus FS application (P < 0.01, P < 0.01 and P < 0.05, respectively). CONCLUSION: In a moderate coagulopathy, FS was proven to be the most efficacious hemostatic agent, producing immediate and sustained hemostasis at the arterial anastomotic site. This high efficacy is in part attributed to the strong tissue adhesive property of this agent. FS application may potentially ease the anastomosis and shorten the duration of timely critical vascular procedures.

Anastomosis, Surgical↗
PubMedDate not supplied

The effect of 2 sealants (FloSeal and Tisseel) on fasciocutaneous flap revascularization.

BACKGROUND: Fasciocutaneous tissue transfer is one of the most common procedures performed in head and neck reconstructive surgery. These composite tissues can be transferred as either a free flap or a pedicled flap. Free tissue transfer has become the reconstructive modality of choice following head and neck oncologic ablation. Synthetic tissue adhesives and hemostatic agents are rapidly gaining popularity in reconstructive surgery. Their ability to decrease bleeding and promote flap sealing and healing has led to a proliferation in their use. To our knowledge, the short-term effect of these substances on healing, as measured by flap revascularization, has not been systematically investigated. METHODS: Fifty-six male Sprague-Dawley rats were divided into 3 groups: a control group, a matrix hemostatic sealant (FloSeal) group, and a 2-component fibrin sealant (Tisseel) group. In each group, the rats had a 3 x 6-cm fasciocutaneous flap based on the inferior epigastric artery elevated and exposed to 2 hours of primary ischemia. In the control group, 0.2 mL of isotonic sodium chloride solution was placed between the flap and its bed, while in the experimental groups, 0.5 mL of FloSeal or 0.2 mL of Tisseel was applied to the wound before closure. Each group was then divided into groups of 5 rats. Each of these groups then had their pedicle divided on postischemic day 4, 5, 6, or 7. The percentage survival of the flap was measured 7 days after pedicle ligation. RESULTS: There was no statistical difference in flap survival of rats treated with isotonic sodium chloride solution, Tisseel, or FloSeal. Ligation of the flap pedicle on days 4, 5, 6, or 7 did not result in any difference in flap survival among the 3 groups. CONCLUSION: The FloSeal and Tisseel demonstrate no short-term detrimental effect on flap survival nor do they seem to affect revascularization in a fasciocutaneous free flap model.

Animals↗