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Clinical and radiographic effects of enamel matrix derivative in the treatment of intrabony periodontal defects: a 12-month longitudinal placebo-controlled clinical trial in adult periodontitis patients
Rosing, C. K., A. M. Aass, et al. (2005), J Periodontol 76(1): 129-33.
Abstract: BACKGROUND: This randomized, double-masked, placebo-controlled clinical trial evaluated the effect of enamel matrix derivative (EMD) on clinical and radiographic parameters of periodontal intrabony defects. METHODS: A split-mouth design was used in 16 chronic periodontitis patients who had similar defects (> or =6 mm of probing depth). Both groups underwent scaling and root planing and were acid-etched with EDTA. The test sites received the EMD solution and the controls a placebo. Clinical examinations of all 16 patients and radiographs of 14 patients were available at baseline and 6 and 12 months after surgery. Clinical outcomes included probing depth (PD) and clinical attachment level (CAL); radiographic analysis was performed using computerized linear measurements. Intergroup comparisons were performed by paired samples t test, and over time comparisons were made by general linear model (alpha = 0.05). RESULTS: A statistically significant improvement over time for PD and CAL and a decrease of the vertical component of the defect was detected in both groups. Comparisons between groups revealed at baseline a mean+/-SD value of CAL of 12.93+/-2.00 and 13.47+/-2.93 for test and control groups, respectively. These values decreased to 10.92+/-1.92 and 11.31+/-1.86 after 12 months for test and control. No statistically significant differences could be observed between groups. PD displayed similar results from 7.57+/-1.02 and 7.38+/-1.16 for test and control groups at baseline to 3.40+/-1.82 and 2.99+/-1.07 after 12 months. If the data are divided into smokers and non-smokers, no differences are observed. CONCLUSION: Use of EMD did not result in more improvement in clinical and radiographic parameters compared to the placebo.

Clinical applications of electron microscopy in the analysis of collagenous biomaterials
Wasserman, A. J., C. J. Doillon, et al. (1988), Scanning Microsc 2(3): 1635-46.
Abstract: Scanning and transmission electron microscopy are of clinical value in assessing the interaction between biomaterials and ingrowing tissues. Ultrastructural information allows the clinician and biomaterials specialist to determine events occurring during wound healing and the biocompatibility of prosthetic devices. This paper reviews some of the experimental and clinical studies done in our laboratory on the use of natural and reconstituted collagen as replacements for connective tissues. Consideration is given to collagen flakes used for the treatment of dermal ulcers, a collagen fiber prosthesis used for tendon and ligament replacement, the effects of chemical preservatives on cartilage used for replacement of tissues during plastic surgery and the growth and orientation of nerve cells on reconstituted collagen fibers. Our results show that reconstituted collagen can be prepared into prosthetic devices which encourage cell attachment and orientation thereby facilitating healing of injured tissues. Furthermore chemical preservation of cartilagenous tissues kills chondrocytes resulting in eventual resorption by inflammatory cells.

Clinical aspects and strategy for biomaterial engineering of an auricle based on three-dimensional stereolithography
Naumann, A., J. Aigner, et al. (2003), Eur Arch Otorhinolaryngol 260(10): 568-75.
Abstract: At the present time, the partial and/or complete reconstruction of an auricle from autologous rib cartilage is one of most widely published techniques. In the field of tissue engineering, different techniques have been described to generate cartilage tissue using isolated chondrocytes. The basis of these tissue-engineering techniques is bioresorbable or non-bioresorbable biomaterials, which serve as a three-dimensional cell carrier. Tissue engineering of an auricle requires preformed bioresorbable biomaterials designed to fit the form of a patient's auricular defect. Three-dimensional imaging acquired from computed tomography scans or laser surface scanning has become an important tool in modern medicine. This study represents the preoperative procedures for the reconstruction of an auricle through tissue engineering in accordance with the clinical aspects. Hyaff 11, a hyaluronic acid derivative, was used as a three-dimensional cell carrier for isolated human nasoseptal chondrocytes. The chondrocytes were amplified in a conventional monolayer culture before the cells were seeded on a hyaluronic non-woven mesh and cultured in vitro for 4 weeks. The chondrogenic potential of human nasal chondrocytes in Hyaff 11 was investigated by confocal laser scanning microscopy, histology (toluidine blue) and immunohistochemistry (collagen type II). Computer-aided design (CAD) and manufacture of an auricle model with stereolithographical methods were used for the prefabrication of a bioresorbable three-dimensional cell carrier designed in the form of a patient's auricular defect. The cell carrier used was Hyaff 11, a fully benzyl-esterified hyaluronic acid derivative. Confocal laser scanning microscopy has shown good cell attachment, a homogenous distribution of amplified chondrocytes and a viability of more than 90%. After 4 weeks in vitro culture the human nasoseptal chondrocytes synthesized new cartilage with the expression of cartilage-specific collagen type II. In order to shape a patient's designed scaffold the auricle model was fitted exactly and symetrically to the contralateral side. Subsequently, the mirror image patient-specific model was used to prepare an identical scaffold model made of a fully benzyl-esterified hyaluronic acid derivative. The bioresorbable scaffold that was produced gave a satisfactory representation of auricle structure. Bioresorbable preformed biomaterials in the form of a patient's auricle defect represent an important prerequisite for the tissue engineering of autologous auricle grafts. Hyaff 11 seems to be a promising material for tissue engineering of cartilage transplants, and the application of this approach will improve conventional reconstructive surgery in the future.

Clinical case reports of injectable tissue-engineered bone for alveolar augmentation with simultaneous implant placement
Ueda, M., Y. Yamada, et al. (2005), Int J Periodontics Restorative Dent 25(2): 129-37.
Abstract: This clinical study was undertaken to evaluate the use of tissue-engineered bone, mesenchymal stem cells, platelet-rich plasma, and beta-tricalcium phosphate as grafting materials for maxillary sinus floor augmentation or onlay plasty with simultaneous implant placement in six patients with 3- to 5-mm alveolar crestal bone height. All 20 implants were clinically stable at second-stage surgery and 12 months postloading. A mean increase in mineralized tissue height of 7.3+/-4.6 mm was evident when comparing the pre- and postsurgical radiographs. Injectable tissue-engineered bone provided stable and predictable results in terms of implant success.

Clinical evaluation of dental implants with surfaces roughened by anodic oxidation, dual acid-etched implants, and machined implants
Aalam, A. A. and H. Nowzari (2005), Int J Oral Maxillofac Implants 20(5): 793-8.
Abstract: PURPOSE: The purpose of this study was the clinical and radiographic comparison of dental implants with surfaces roughened by anodic oxidation (TiUnite), dual acid-etched implants (Osseotite), and machined implants. MATERIALS AND METHODS: Seventy-four patients (mean age, 52.8 +/- 14.2 years; range, 23 to 80 years; 41 men and 33 women) received 198 dental implants-58 TiUnite implants (25 patients), 52 Osseotite implants (27 patients), and 88 machined implants (22 patients). Clinical measurements and radiographs were evaluated at the time of surgery, at the restorative phase, and 2 years postloading. To account for statistical correlation among multiple implants in the same subject, a "per patient" mode of analysis was conducted. A 1-way analysis of variance of bone loss was conducted by type of implant as well by area of the mouth. In addition, differences in mean bone loss were tested for bone density category, gender, and smoking status using Student t tests. RESULTS: Eighteen TiUnite implants (31.0%) were placed in the maxilla and 40 (69.0%) in the mandible. The Osseotite group included 29 maxillary implants (55.8%) and 23 mandibular implants (44.2%). The machined group included 49 maxillary implants (55.7%) and 39 mandibular implants (44.3%). All 198 implants were considered radiographically and clinically successful. No mobility, signs of infection, or inflammation were detected. DISCUSSION: Implant size, location, bone quality, gender, age, and smoking did not influence the comparative clinical outcomes of the 3 groups (P >.05). A trend toward greater coronal bone loss in the TiUnite group was detected. CONCLUSION: Within the limitations of the present study, TiUnite, Osseotite, and machined dental implants had similar short-term clinical outcomes. No statistically significant differences in bone loss could be detected among implant groups or among the different regions of the oral cavity. The present data underlined the significance of surgical and prosthetic treatment planning.

Clinical evaluation of poly(2-methoxyethylacrylate) in primary coronary artery bypass grafting
Vang, S. N., C. P. Brady, et al. (2005), J Extra Corpor Technol 37(1): 23-31.
Abstract: In an attempt to make cardiopulmonary bypass (CPB) less traumatic for patients undergoing cardiac surgery, extracorporeal circuits (ECC) have been modified to achieve this goal. Poly(2-methoxyethylacrylate) (PMEA, X-coating) is a new polymer coating used in the ECC. PMEA studies have shown excellent biocompatibility with the components of blood. In this evaluation, PMEA-coated ECC were compared with control (CTR) circuits with emphasis on hematological parameters, peri-operative homologous blood product usage, and clinical outcomes. Patients undergoing elective coronary artery bypass grafting were randomized to either a PMEA group (n = 30) or a CTR group (n = 30). Extracorporeal circuit components in the PMEA group were coated except for the cardioplegia delivery device and cannulas. Patients in the CTR group had just the arterial line filter coated. The following hematological parameters were measured: platelet count (PLT), white blood cell count (WBC), red blood cell count (RBC), and hematocrit (Hct). Blood product usage was observed along with clinical outcomes for the following parameters: ventilation time, mediastinal tube output, intensive care unit (ICU) and hospital lengths of stay. The preoperative patient profiles were comparable between the two groups. The PMEA group had marginally higher CPB times (134+/-31.9 vs. 118+/-33.7 minutes) and cross clamp times (83.9+/-21.3 vs. 73.7+/-21.6 minutes), however no significant differences were reached. Platelet count, RBC, and Hct levels were also comparable between groups with no significant differences. However, there was a significant difference in WBC between groups (p = 0.041). Less platelets were administered both intraoperatively and 48 hours postoperatively in the PMEA group. The authors evaluated PMEA-coating by measuring clinical outcomes, such as ventilation time, ICU and hospital lengths of stay, and homologous blood utilization. PMEA patients trended towards less homologous blood transfusions, which helped save an average of $83.41 per patient. Further clinical studies are needed to evaluate the benefits of this new polymer coating.

Clinical indications of calcium-phosphate biomaterials and related composites for orthopedic procedures
Block, J. E. and M. R. Thorn (2000), Calcif Tissue Int 66(3): 234-8.

Clinical outcome of 285 Medpor grafts used for craniofacial reconstruction
Cenzi, R., A. Farina, et al. (2005), J Craniofac Surg 16(4): 526-30.
Abstract: Porous polyethylene (Medpor) is an alloplastic material worldwide used for craniofacial reconstruction. To evaluate complications and risk factors associated with this synthetic graft, a retrospective study was performed. A series of 285 Medpor grafts were placed in 187 patients. Age, sex, diagnosis at admission, site, type of surgical insertion, type of fixation, and outcome (no complications, anesthesia, exposure, infection, and implant remodeling and removal) are considered. By means of univariate and multivariate analyses, we detect variables most associated with poor outcome. Univariate analysis showed that graft "survival" curves stratified according to (1) diagnosis at admission and (2) site are statistically significant. Subsequently, a Cox analysis was performed: both variables are also predictors of graft outcome. Porous polyethylene is a reliable alloplastic material that can be satisfactory used for craniofacial reconstruction. However, some sites (i.e., nose, maxilla, and ear) and diagnosis at admission (i.e., syndromic patients previously operated) are related to an higher risk of implant failure.

Clinical parameters associated with success and failure of single-tooth titanium plasma-sprayed cylindric implants under stricter criteria: a 5-year retrospective study
Elkhoury, J. S., E. A. McGlumphy, et al. (2005), Int J Oral Maxillofac Implants 20(5): 687-94.
Abstract: PURPOSE: The purpose of this study was to determine the clinical parameters associated with long-term success and failure of single-tooth titanium plasma-sprayed (TPS) cylindric implants. MATERIALS AND METHODS: Thirty-nine implants in 39 subjects were followed for 5 years. The following data were collected: subject age and gender, implant length, implant location, bone density, and implant position in relation to crestal bone. Assessments made at recall intervals included: Gingival Index (GI), probing depth, relative attachment level, and standardized radiographs. Failure was defined as a mean annual attachment loss rate (ALR) of > or = 0.25 mm after the first year of implant function. Between-group differences were assessed nonparametrically using the Mann-Whitney and chi-square tests. RESULTS: Nineteen implants were considered successes and 20 were considered failures with respective mean ALRs of 0.12 +/- 0.07 mm and 0.42 +/- 0.19 mm. The following factors were associated with success: longer implants (P <.001), lower GI (P <.001), higher bone density (P <.0001), and implant position at the crest or supracrestally (P <.0001). Age, gender, probing depth, and implant location were not related to outcome. CONCLUSIONS: A model using attachment loss as a parameter for success and failure has not been previously utilized. Longer implants, lower GI, higher bone density, and implant position at the crest or supracrestally were clinical factors associated with long-term success of single-tooth TPS cylindric implants in this patient population.

Clinical performance and biocompatibility of novel hyaluronan-based heparin-bonded extracorporeal circuits
Gunaydin, S., K. McCusker, et al. (2005), J Extra Corpor Technol 37(3): 290-5.
Abstract: We tested documented in vitro and ex vivo advantages of novel hyaluronan based heparin bonded extracorporeal circuits in a prospective randomized study. During the period from June until September 2005, 40 patients undergoing reoperation for coronary artery bypass grafting were allocated into two equal groups (n = 20): Group 1 was treated with hyaluronan-based heparin-bonded circuits and group 2 was treated with uncoated control circuits. Complete blood count, fibrinogen, albumin, C3a, interleukin-2 levels, and thromboelastographic data were documented after induction of anesthesia (T1) and heparin administration before cardiopulmonary bypass (CPB) (T2), 15 minutes after initiation of CPB (T3), before cessation of CPB (T4), 15 minutes after reversal with protamine (T5), and the first postoperative day at 8:00 a.m. (T6). Hollow fibers were collected for consecutive biomaterial analysis by optical and scanning electron microscopy (SEM). Desorbed protein deposition on fibers was compared by spectrophotometry. Leukocyte counts were lower in T4-T6 in group 1 (p <.05). Platelet counts demonstrated significant differences at T4 and T5 in coated group (p <.05). Albumin and fibrinogen levels were better preserved in Group 1 at T4, T5 and T4, T6, consecutively (p <.05). C3a and IL-2 levels were lower at T3-T5 and T4-T5 in intervention group (p <.05). Postoperative hemorrhage was 412 +/- 50 mL in group 1 and 684 +/- 50 ml in group 2 (p <.05). Respiratory support time was shorter in group 1 versus control (p <.05). Platelet adhesion was significantly lower in intervention group. Amount of desorbed protein was 1.44 +/- 0.01 mg/dL in group 1 and 1.94 +/- 0.01 mg/dL in control (p <.05). SEM and spectrophotometry demonstrated better surface preservation in the hyaluronan coated group. Novel hyaluronan-based heparin-bonded circuits reduce platelet adhesion-aggregation and protein adsorption and provide better perioperative clinical parameters through platelet, albumin, and fibrinogen-sparing effects.

Clinical performance of a regenerative strategy for intrabony defects: scientific evidence and clinical experience
Cortellini, P. and M. S. Tonetti (2005), J Periodontol 76(3): 341-50.
Abstract: BACKGROUND: The aim of the present study was to evaluate the clinical performance of a regenerative strategy for the treatment of deep intrabony defects. METHODS: This patient cohort study involved 40 patients with one deep interdental intrabony defect each. They were treated with periodontal regeneration using four different regenerative methods (expanded polytetrafluoroethylene [ePTFE] titanium reinforced membranes, bioabsorbable membranes alone, bioabsorbable membranes with a bone replacement graft [combination], or enamel matrix derivative), according to predefined criteria and decision-making algorithms. Defects were accessed with papilla preservation flaps performed with the aid of an operating microscope and microsurgical instruments. A stringent plaque control regimen was enforced in all the patients during the 1-year observation period. Outcomes included evaluation of the complete primary closure of the interdental space (CLOSURE), gains in clinical attachment (CAL), and reductions in probing depths (PD). RESULTS: CLOSURE was achieved in all treated defects and was maintained in 90% of cases for the entire healing period. At 1 year the observed CAL gains were 6 +/- 1.8 mm on average, corresponding to a resolution of 92.1% +/- 12% of the initial intrabony (CAL%) component of the defect. Average PD reduction was 6.1 +/- 1.9 mm and was associated with minimal increase in gingival recession (-0.1 +/- 0.7 mm). The 12 sites treated with titanium reinforced ePTFE membranes resulted in a 1-year CAL gain of 6.8 +/- 2.2 mm (CAL%: 94.7 +/- 13.4); the 11 cases treated with combination therapy showed a 1-year CAL gain of 5.4 +/- 1.7 mm (CAL%: 88.2 +/- 9.6); the seven sites treated with bioabsorbable barriers resulted in 5.9 +/- 1.2 mm of CAL gain (CAL%: 88.9 +/- 11.5); and the 10 sites treated with enamel matrix gained on average 5.9 +/- 1.5 mm of CAL (CAL%: 88.9 +/- 11.5). No significant differences were observed among the four approaches. CONCLUSION: The use of an evidence-based regenerative strategy resulted in clinically relevant amounts of CAL gains, shallow pockets, and minimal gingival recession with the four regenerative approaches.

Clinical technique and biomaterials selection
Sadan, A. (2005), Quintessence Int 36(8): 591.

Clinical validation of a structural porous tantalum biomaterial for adult reconstruction
Bobyn, J. D., R. A. Poggie, et al. (2004), J Bone Joint Surg Am 86-A Suppl 2: 123-9.

Clinical, histologic and electron microscopic findings after injection of a calcium hydroxylapatite filler
Marmur, E. S., R. Phelps, et al. (2004), J Cosmet Laser Ther 6(4): 223-6.
Abstract: BACKGROUND: Calcium hydroxylapatite (CaHa) is one of many newly available soft tissue fillers. OBJECTIVE: We have, in this pilot study, evaluated the clinical, histologic and electron microscopic ultrastructural changes seen with CaHa at 1 and 6 months after skin injection. METHODS: Each of the three subjects was injected in the postauricular area with 0.1 cc of CaHa gel. A 3-mm punch tissue biopsy was taken at 1 and 6 months post-injection. Biopsies were analyzed by histopathology and electron microscopy. Clinical results after injection of the nasolabial folds were also evaluated. RESULTS: CaHa particles were found to persist at 6 months with evidence of new collagen formation being seen. Patients still showed clinical improvement at this time. CONCLUSION: This study is the first in vivo ultrastructural analysis of the biologic response to CaHa in human skin. CaHa shows clinical, histologic and electron microscopic evidence of persistence at 6 months.

Clinical, histologic, and histomorphometric evaluation of mineralized solvent-dehydrated bone allograf (Puros) in human maxillary sinus grafts
Noumbissi, S. S., J. L. Lozada, et al. (2005), J Oral Implantol 31(4): 171-9.
Abstract: Demineralized freeze-dried bone allografts (DFDBA) have been successfully used alone or in composite grafts for many decades. Little research has been done on the effect of retaining the mineral content of bone allografts. This study histologically and histomorphometrically evaluated a new mineralized bone allograft material placed in human atrophic maxillary sinuses. Seven partially edentulous patients requiring sinus grafts before implant placement were selected for this study Their age range was 56 to 81 years (mean 67.7 years). Test grafts consisted of a mineralized solvent-dehydrated cancellous bone allograft, and control grafts were a composite of DFDBA and deproteinized bovine bone xenograft (1:1). Bilateral cases (n = 3) received both test and control grafts on opposite sides, and unilateral cases received either a test (n = 3) or control (n = 1) graft only. At 10 months, core biopsies were taken from each graft site, and dental implants were placed into the augmented bone. All bone grafts resulted in new bone formation and all implants osseointegrated. Test grafts resorbed and were replaced by newly formed bone significantly faster and in greater quantities than were control grafts. No complications with grafts or implants were noted. Both test and control grafts achieved excellent results. The faster bone formation observed with the test graft may be due, in part, to its smaller particle size compared with the bovine portion of the control graft. Test grafts were either replaced by new bone or displayed new bone-to-particle surface contact in higher percentages than did control grafts. No differences in osseointegration or graft stability were noted 2 years after the study.

Cloning, high yield overexpression, purification, and characterization of AlgH, a regulator of alginate biosynthesis in Pseudomonas aeruginosa
Bieber Urbauer, R. J., J. M. Gilmore, et al. (2005), Protein Expr Purif 43(1): 57-64.
Abstract: The most common cause of mortality among cystic fibrosis sufferers is infection by antibiotic resistant strains of Pseudomonas aeruginosa. Means to control these strains continue to be an important goal. An integral component of the ability of many of these strains to defy antibiotic therapies is the protection afforded by the mucoexopolysaccharide alginate. Production of alginate by P. aeruginosa is tightly regulated at the transcriptional level. AlgH, a putative transcriptional regulator, is involved in regulating alginate biosynthesis as well as nucleoside diphosphate kinase activity and succinyl coenzyme A synthetase activity in P. aeruginosa. Sequence homologues are found in many bacterial species. Here, we describe a method for high level overexpression and high yield/high purity production of AlgH for biophysical and functional studies. The algH gene was cloned and AlgH was overexpressed in Escherichia coli using a commercially available vector with an inducible T7 promoter. We purified the recombinantly produced protein using a rapid classical purification scheme. The yield of purified protein, either isotopically labeled for NMR studies or unlabeled, is excellent (30-37 mg of purified protein per liter of minimal media culture), as is the purity (>95% pure). Analysis of the secondary structure using circular dichroism and NMR indicates that the protein is comprised of both beta-sheet and alpha-helical secondary structural elements. Heteronuclear NMR spectra indicate that AlgH is a monodisperse, folded globular protein. This rapid, high yield, and high purity method for AlgH production will permit further biophysical characterization of this protein including high resolution structural studies.

Closer to nature: new biomaterials and tissue engineering in ophthalmology
Allan, B. (1999), Br J Ophthalmol 83(11): 1235-40.

Closure of a benign tracheoesophageal fistula by using a coated, self-expanding plastic stent in a patient with a history of esophageal atresia
Adler, D. G. and D. K. Pleskow (2005), Gastrointest Endosc 61(6): 765-8.

Coagulation on biomaterials in flowing blood: some theoretical considerations
Basmadjian, D., M. V. Sefton, et al. (1997), Biomaterials 18(23): 1511-22.
Abstract: Are truly inert biomaterials feasible? Recent mathematical models of coagulation which are reviewed here suggest that such materials are impossible. This conclusion, which is certainly consistent with our collective experimental evidence, arises from the calculation that conversion of Factor XI to XIa never drops to zero even at the highest flow rates and with virtually no Factor XIIa bound to a surface. Residual amounts of XIa are still formed which can in principle kick-off the coagulation cascade. Furthermore, if the flow rates and corresponding mass transfer coefficients are low and in spite of these near-vanishing levels of the initiating coagulants, the surprising result is that substantial amounts of thrombin are produced. On the contrary, under slightly higher flow conditions, there can be more substantial levels of initiating coagulants, yet paradoxically thrombin production is near zero. This article presents a theoretical understanding of the events which take place during the interaction of biomaterials with flowing blood. We follow these events from the time of first contact to the final production of thrombin. The effect of flow and surface activity on the contact phase reactions is examined in detail and the two are found to be intertwined. The common pathway is also examined and here the main feature is the existence of three flow dependent regions which produce either high or very low levels of thrombin, as well as multiple thrombin steady states. In a final analysis we link the two segments of the cascade and consider the events which result. In addition, we note that multiple steady states arise only in the presence of two (thrombin) feedback loops. Single loops or the bare cascade will produce only single steady states. With some imagination one can attribute to the feedback loops the role of providing the cascade with a mechanism to produce high thrombin levels in case of acute need (e.g. bleeding) or to allow levels to subside to 'stand-by' when there is no need for clotting. We present this as a partial answer to the question: Why is the coagulation cascade so complex and what is the importance of the feedback loops?

Coating of a surface with 2-methacryloyloxyethyl phosphorylcholine (MPC) co-polymer significantly reduces retention of human pathogenic microorganisms
Hirota, K., K. Murakami, et al. (2005), FEMS Microbiol Lett 248(1): 37-45.
Abstract: The present study compares the retention of four species that are often isolated in association with biomedical device-related infections - Staphylococcus aureus, Streptococcus mutans, Pseudomonas aeruginosa, and Candida albicans - to three different surfaces. All four bacterial species were found to bind significantly less well to MPC-coated surfaces than to non-coated surfaces. We attribute this effect to the "superhydrophilicity" of MPC-coated surfaces, whereas hydrophobic surfaces are well known to reduce bacterial retention and thus to inhibit a crucial step in the formation of bacterial biofilms that lead to biomedical device-related infections and complications.

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