PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 15857102

Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation.

Joseph P Fiorellini·T Howard Howell·David Cochran·Jay Malmquist·Leslie C Lilly·Daniel Spagnoli·Joseph Toljanic·Archie Jones·Myron Nevins
View original source ↗Export metadata ↓

Abstract

BACKGROUND: Conventional dentoalveolar osseous reconstruction often involves the use of grafting materials with or without barrier membranes. The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on a bioabsorbable collagen sponge (ACS) compared to placebo (ACS alone) and no treatment in a human buccal wall defect model following tooth extraction. METHODS: Eighty patients requiring local alveolar ridge augmentation for buccal wall defects (> or =50% buccal bone loss of the extraction socket) of the maxillary teeth (bicuspids forward) immediately following tooth extraction were enrolled. Two sequential cohorts of 40 patients each were randomized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2/ACS, placebo (ACS alone), or no treatment in a 2:1:1 ratio. Efficacy was assessed by evaluating the amount of bone induction, the adequacy of the alveolar bone volume to support an endosseous dental implant, and the need for a secondary augmentation. RESULTS: Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2/ACS had significantly greater bone augmentation compared to controls (P < or =0.05). The adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2/ACS groups compared to no treatment or placebo. In addition, bone density and histology revealed no differences between newly induced and native bone. CONCLUSION: The data from this randomized, masked, placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants.

Explore related subjects

Absorbable ImplantsAlveolar Bone LossAlveolar Ridge AugmentationAnalysis of VarianceBone DensityBone Morphogenetic Protein 2Bone Morphogenetic ProteinsBone RegenerationCollagenDouble-Blind MethodDrug CarriersFemaleHumansMaleMiddle AgedOral Surgical Procedures, PreprostheticRecombinant ProteinsStatistics, NonparametricTooth ExtractionTooth SocketTransforming Growth Factor betaClinical TrialJournal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov't

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

Joseph P Fiorellini, T Howard Howell, David Cochran, Jay Malmquist, Leslie C Lilly, Daniel Spagnoli, Joseph Toljanic, Archie Jones, Myron Nevins. 2005. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation.. https://doi.org/10.1902/jop.2005.76.4.605

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2006

In vivo biodegradability and biocompatibility evaluation of novel alanine ester based polyphosphazenes in a rat model.

Amino acid ester substituted polyphosphazenes are attractive candidates for various biomedical applications because of their biocompatibility, controllable hydrolytic degradation rates, and nontoxic degradation products. In this study, the biocompatibility of three L-alanine ethyl ester functionalized polyphosphazenes was evaluated in a subcutaneous rat model. The polymers used in the study were poly[bis(ethylalanato)phosphazene] (PNEA), poly[(50% ethylalanato) (50% methylphenoxy) phosphazene] (PNEA(50)mPh(50)), and poly[(50% ethylalanato)(50% phenyl phenoxy) phosphazene] (PNEA(50)PhPh(50)). Polymer disks of diameter 7.5 mm were prepared by a solvent evaporation technique and were implanted subcutaneously in rats. After 2, 4, and 12 weeks, the polymer along with the surrounding tissues were excised, prepared, and viewed by light microscopy to evaluate the tissue responses of the implanted polymers. The tissue responses were classified as minimal, mild, or moderate, based on a biocompatibility scheme developed in our laboratory. Minimal inflammation was characterized by the presence of few neutrophils, erythrocytes, and lymphocytes; mild response was characterized by the predominant presence of macrophages, fibroblasts, or giant cells; and moderate inflammation was characterized by the abundance of macrophages, giant cells, and by the presence of tissue exudates. The in vivo degradation profiles of the polymers at various time points were evaluated by gel permeation chromatography (GPC). PNEA and PNEA(50)mPh(50) matrices elicited varying levels of tissue responses during the 12-week implantation period. At 2 weeks both polymers evoked a moderate response, and by 12 weeks the response was found to be mild. However, PNEA(50)PhPh(50) elicited a mild response at the end of 2 weeks and demonstrated a further decreased inflammatory response after 12 weeks. The in vivo degradation of the polymers was followed by determining the molecular weights of the explanted polymer disks. PNEA and PNEA(50)mPh(50) disks showed significant decrease in molecular weight after 2 weeks of implantation. The molecular weights of PNEA and PNEA(50)mPh(50) residues could not be determined by GPC after 12 weeks of implantation because of almost complete degradation. On the other hand the in vivo degradation of PNEA(50)PhPh(50) was found to be slow, with a 63% loss in molecular weight in 12 weeks. Furthermore, this polymer maintained its shape and structure during the entire study. Thus, these polymers demonstrated excellent tissue compatibility and in vivo biodegradability and can be potential candidates for various biomedical applications.

Absorbable Implants↗
PubMed2006

Regeneration of bicortical defects in the iliac crest of estrogen-deficient sheep, using new biodegradable polyurethane bone graft substitutes.

Porous scaffolds for cancellous bone graft substitutes were prepared from new experimental biodegradable aliphatic polyurethane elastomers with varying hydrophilicity. The ratios of the hydrophilic-to-hydrophobic content in the polymers were 30-70, 50-50, and 70-30%, respectively. The hydrophilic component consisted of poly(ethylene oxide) diol and the hydrophobic component of poly(epsilon-caprolactone) diol. To promote the materials' biological performance, the calcium complexing moiety, the polysaccharide, and vitamin D(3) were incorporated into the polymer chain upon synthesis. The scaffolds had an interconnected porous structure with an average pore size in the range of 300-2,000 microm and pore-to-volume ratios of (85 +/- 5)%. The bone substitutes were implanted (press-fit) in biocortical 10 x 10 mm(2) defects created in the tuber coxae of 21 skeletally mature Warhill ewes, which were ovariectomized 12 months prior to implantation. At the time of euthanasia at 18 and 25 months, all the defects in the ilium implanted with polyurethane bone substitutes had healed with new bone. The extent of bone healing depended on the chemical composition of the polymer from which the implant was made, although for the same material there were animal-related differences in healing. The structure of the newly formed cancellous bone was radiographically and histologically similar to the native bone. The implants from polymers with the incorporated calcium-complexing additive were the most effective promoters of bone healing, followed by those with vitamin D(3) and polysaccharide-containing polymer. There was no bone healing in the control defects.

Absorbable Implants↗
PubMed2006

Biodegradable and metallic interference screws in anterior cruciate ligament reconstruction surgery using hamstring tendon grafts: prospective randomized study of radiographic results and clinical outcome.

BACKGROUND: The use of biodegradable screws in anterior cruciate ligament reconstruction has grown in popularity. PURPOSE: To compare the clinical and radiographic results in arthroscopically assisted anterior cruciate ligament reconstruction using 4-strand hamstring tendon grafts and either metallic (metal group) or biodegradable (PLLA group) interference screw fixation. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A randomized series of 77 patients, all with a unilateral anterior cruciate ligament rupture, was included in the study. The preoperative assessments in both groups were similar in gender, Tegner activity level, Lysholm score, KT-1000 arthrometer measurements, and single-legged hop test results. In both groups, interference screw fixation of the graft was used at both ends, and 68 of 77 (88%) patients returned for a radiographic examination at 6 and 24 months, respectively. RESULTS: At follow-up, no significant differences were found between the 2 groups in KT-1000 arthrometer laxity measurements, Tegner activity level, or Lysholm score. The PLLA group had a significantly better outcome in the single-legged hop test and the final International Knee Documentation Committee classification (P = .007 and P = .03, respectively). At 6 and 24 months after the index operation, the PLLA group displayed significantly larger drill holes on the radiographs than did the metal group on both the tibial (8.1 vs 6.6 mm at 6 months [P = .0007]; 6.0 vs 3.2 mm at 24 months [P < .0001]) and femoral sides (7.8 vs 5.6 mm at 6 months [P < .0001]; 6.3 vs 1.9 mm at 24 months [P < .0001]). CONCLUSION: There were significantly larger radiographically visible drill holes on both the tibial and femoral sides in the PLLA group compared with the metal group at 6 and 24 months. Clinical examination at 2 years revealed no major differences between the groups. The larger drill holes in the PLLA group did not correlate with inferior clinical results.

Absorbable Implants↗