Randomized clinical trial on the efficacy of Escherichia coli-derived rhBMP-2 with β-TCP/HA in extraction socket Prospective randomized, controlled trial of sinus grafting using Escherichia-coli-produced rhBMP-2 with a biphasic calcium phosphate carrier compared to deproteinized bovine bone. Effect of rhBMP-2 on guided bone regeneration in humans. Measuring the efficacy of rhBMP-2 to regenerate bone: a radiographic study using a commercially available software program. A randomized-controlled clinical trial evaluating clinical and radiological outcomes after 3 and 5 years of dental implants placed in bone regenerated by means of GBR techniques with or without the addition of BMP-2. Buccal bone formation after flapless extraction: a randomized, controlled clinical trial comparing recombinant human bone morphogenetic protein 2/absorbable collagen carrier and collagen sponge alone. Ridge preservation using demineralized bone matrix gel with recombinant human bone morphogenetic protein-2 after tooth extraction: a randomized controlled clinical trial. Horizontal ridge augmentation of the atrophic anterior maxilla using rhBMP-2/ACS or autogenous bone grafts: a proof-of-concept randomized clinical trial. De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. Anterior Lumbar Interbody Fusion Using rhBMP-2 With Tapered Interbody Cages Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. Cancer risk from bone morphogenetic protein exposure in spinal arthrodesis. 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. Pivotal, randomized, parallel evaluation of recombinant human bone morphogenetic protein-2/absorbable collagen sponge and autogenous bone graft for maxillary sinus floor augmentation.
PURPOSE This r and omized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the β-TCP bone graft material that contains ErhBMP-2 . MATERIAL S AND METHODS This study involved 72 patients at the 3 study centers . The patients , who were divided into 2 groups : the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction . CT was taken before and 3 months after the transplantation and healing status was compared between the two groups . The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width . The paired t test was used to determine the significance of the changes ( P<.05 ) . RESULTS Changes in alveolar bone height were -1.087 ± 1.413 mm in the control group and -.059 ± 0.960 mm in the experimental group ( P<.01 ) . At 25 % extraction socket length [ ESL ] , the changes were 0.006 ± 1.149 mm in the control group and 1.279 ± 1.387 mm in the experimental group . At 50 % ESL , the changes were 0.542 ± 1.157 mm and 1.239 ± 1.249 mm , respectively ( P<.01 for 25 % ESL , and P<.05 for 50 % ESL ) . During the experiment , no adverse reactions to the graft material were observed . CONCLUSION ErhBMP-2 coated β-TCP/HA were found to be more effective in preserving alveolar bone than conventional β-TCP/HA alloplastic bone graft material AIM This study compared the effects of Escherichia-coli-produced recombinant human bone morphogenetic protein 2 ( ErhBMP-2 ) with a biphasic calcium phosphate ( BCP ) carrier to those of deproteinized bovine bone in human maxillary sinus floor augmentation . MATERIAL AND METHODS Screening for this clinical trial selected 56 sites that provided informed consent to participate , of which 46 were ultimately enrolled and 41 were finally included in the study . The sites were divided into two groups using a r and om-number table , and the material was applied . A trephine biopsy was performed after 24 weeks , and implants wider than the biopsy site were inserted . Computed tomography and plain panoramic images were obtained immediately and then again at 24 weeks after the surgery . Radiographic images were reconstructed to allow measurement of the linear and volumetric changes . The biopsy sample s were processed for histologic and histometric analyzes . RESULTS All sites healed uneventfully with no complications . Radiographic analysis revealed a tendency for the volume to increase , but the difference was not statistically significant in either group . Comparison of volumetric changes between the two groups also revealed no significant difference . Moreover , none of the histometric parameters differed significantly between the groups , although different healing patterns were observed on histologic analysis . CONCLUSIONS AND CLINICAL IMPLICATION S It can be concluded that sinus augmentation with ErhBMP-2 carrying BCP carrier did not enhance bone regeneration compared to the conventional treatment using deproteinized bovine bone at 24 weeks after the surgery The aim of the present clinical study was to test whether or not the addition of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) to a xenogenic bone substitute mineral ( Bio-Oss ) will improve guided bone regeneration therapy regarding bone volume , density and maturation . In 11 partially edentulous patients , 34 Brånemark implants were placed at two different sites in the same jaw ( five maxillae , six m and ibles ) requiring lateral ridge augmentation . The bone defects were r and omly assigned to test and control treatments : the test and the control defects were both augmented with the xenogenic bone substitute and a resorbable collagen membrane ( Bio-Gide ) . At the test sites , the xenogenic bone substitute mineral was coated with rhBMP-2 in a lyophilization process . Following implant insertion ( baseline ) , the peri-implant bone defect height was measured from the implant shoulder to the first implant-bone contact . After an average healing period of 6 months ( SD 0.17 , range 5.7 - 6.2 ) , the residual defects were again measured and trephine burs were used to take 22 bone biopsies from the augmented regions . The healing period was uneventful except for one implant site that showed a wound dehiscence , which spontaneously closed after 4 weeks . Later at reentry , all implants were stable . At baseline , the mean defect height was 7.0 mm ( SD 2.67 , range 3 - 12 mm ) at test and 5.8 mm ( SD 1.81 , range 3 - 8 mm ) at control sites . At reentry , the mean defect height decreased to 0.2 mm ( SD 0.35 , range 0 - 1 mm ) at test sites ( corresponding to 96 % vertical defect fill ) and to 0.4 mm ( SD 0.66 , range 0 - 2 mm ) at the control site ( vertical defect fill of 91 % ) . Reduction in defect height from baseline to reentry for both test and control sites was statistically significant ( Wilcoxon P<0.01 ) . Histomorphometric analysis showed an average area density of 37 % ( SD 11.2 , range 23 - 51 % ) newly formed bone at test sites and 30 % ( SD 8.9 , range 18 - 43 % ) at control sites . The fraction of mineralized bone identified as mature lamellar bone amounted to 76 % ( SD 14.4 , range 47.8 - 94 % ) at test compared to 56 % ( SD 18.3 , range 31.6 - 91.4 % ) at control sites ( paired t-test P<0.05 ) . At BMP-treated sites 57 % ( SD 16.2 , range 29 - 81 % ) and at control sites 30 % ( SD 22.6 , range 0 - 66 % ) of the surface of the bone substitute particles were in direct contact with newly formed bone ( paired t-test P<0.05 ) . It is concluded that the combination of the xenogenic bone substitute mineral with rhBMP-2 can enhance the maturation process of bone regeneration and can increase the graft to bone contact in humans . rhBMP-2 has the potential to predictably improve and accelerate guided bone regeneration therapy This radiographic study evaluated the efficacy of different concentrations of rhBMP-2 to regenerate bone in alveolar defects in the anterior maxilla . The study was performed using reasonably st and ardized CT examinations and the Simplant program . The radiographic measurements were further refined by careful st and ardization of the measured regions of interest . There was a statistically significant difference in bone formation between subjects treated with a concentration of 1.5 mg/mL rhBMP-2 compared with each of the other groups . There was no statistically significant difference in bone volume between any of the other groups . None of the groups showed a loss in bone volume OBJECTIVE The aim of this r and omized-controlled clinical trial was to evaluate the long-term outcome of implants placed in bone augmented with a xenogenic bone substitute material and a collagen membrane with or without the addition of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) . MATERIAL AND METHODS Eleven patients received a total of 34 implants placed into sites exhibiting lateral bone defects . In a split mouth design , the defects were r and omly treated with the graft material and the collagen membrane either with ( test ) or without ( control ) rhBMP-2 . The patients were examined 3 and 5 years after insertion of the prosthetic restoration . Student 's paired t-test was performed to detect differences between the two groups . RESULTS The survival rate at 3 and 5 years was 100 % for both groups . The peri-implant soft tissues were stable and healthy without any difference between the two groups . The prosthetic reevaluation demonstrated four loose prosthetic screws during the first 3 years and seven ceramic chippings after 3 and 5 years . The mean distance between the first bone to implant contact to implant abutment junction at 3 years was 1.37 mm ( test ) , 1.22 mm ( control ) , and 1.38 mm ( test ) , and 1.23 mm ( control ) at 5 years . The difference of < 0.2 mm between test and control implants was not statistically significant . The mean change of the marginal bone level between baseline and 5 years ranged from -0.07 mm ( mesial , test ) , -0.11 mm ( distal , test ) , -0.03 mm ( mesial , control ) , to + 0.13 mm ( distal , control ) . No statistically significant differences were observed between test and control sites . CONCLUSION Implants placed in bone augmented with and without rhBMP-2 revealed excellent clinical and radiological outcomes after 3 and 5 years BACKGROUND Flapless extraction of teeth allows for undisturbed preservation of the nearby periosteum and a source of osteoprogenitor cells . Recombinant human bone morphogenetic protein 2 ( rhBMP-2 ) has been used for different bone augmentation purpose s with great osteoinductive capacity . The aim of this study is to compare the bone regenerative ability of rhBMP-2 on an absorbable collagen sponge ( ACS ) carrier to a collagen sponge ( CS ) alone in extraction sites with ≥50 % buccal dehiscence . METHODS Thirty-nine patients requiring extraction of a hopeless tooth with ≥50 % buccal dehiscence were enrolled . After flapless extraction and r and omization , either rhBMP-2/ACS carrier or CS alone was placed in the extraction site . After extraction , a baseline cone beam computed tomography ( CBCT ) scan was obtained of the site , and a similar scan was obtained 5 months postoperatively . Medical imaging and viewing software were used to compare the baseline and 5-month postoperative images of the study site and assess ridge width measurements , vertical height changes , and buccal plate regeneration . RESULTS Radiographically , CBCT analysis showed that with ≥50 % of buccal bone destruction , rhBMP-2/ACS was able to regenerate a portion of the lost buccal plate , maintain theoretical ridge dimensions , and allow for implant placement 5 months after extraction . The test group performed significantly ( P < 0.05 ) better in regard to clinical buccal plate regeneration ( 4.75 versus 1.85 mm ) , clinical ridge width at 5 months ( 6.0 versus 4.62 mm ) , and radiographic ridge width at 3 mm from the alveolar crest ( 6.17 versus 4.48 mm ) after molar exclusion . There was also significantly ( P < 0.05 ) less remaining buccal dehiscence , both clinical ly ( 6.81 versus 10.0 mm ) and radiographically ( 3.42 versus 5.16 mm ) , at 5 months in the test group . Significantly ( P < 0.05 ) more implants were placed in the test group without the need for additional augmentation . The mean loss in vertical ridge height ( lingual/palatal ) was less in the test sites but was not significantly ( P = 0.514 ) different between the test and control groups ( 0.39 versus 0.64 mm ) . CONCLUSIONS rhBMP-2/ACS compared to CS alone used in flapless extraction sites with a buccal dehiscence is able to regenerate lost buccal plate , maintain theoretical ridge dimensions , and allow for implant placement 5 months later PURPOSE The aim of the present r and omized controlled trial was to determine the safety and efficacy of injectable demineralized bone matrix ( DBM ) gel combined with recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) on alveolar ridge preservation after tooth extraction . MATERIAL S AND METHODS A total of 69 patients were r and omly assigned to either a test group ( n = 35 ) or a control group ( n = 34 ) . In the test group , DBM , together with rhBMP-2 ( 0.05 mg/mL ; rhBMP-2/DBM ) was transplanted into the extraction sockets . The control group received DBM alone . The safety of rhBMP-2/DBM was evaluated by oral examination , serum chemistry , and hematologic examination . The radiographic changes in alveolar bone height and width were measured using computed tomography scans performed immediately after transplant and again 3 months thereafter . RESULTS Healing was uneventful in all subjects , with no anticipated adverse events and no clinical ly significant changes in the serum chemistry and hematologic findings . No meaningful immune response was found among the study groups . No significant difference was found in the radiographic changes of alveolar bone height and width ( P > .05 ) . CONCLUSIONS This new injectable bio material can be used easily and safely in clinical applications AIM To compare the effect of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) in an absorbable collagen sponge carrier ( ACS ) with autogenous bone graft for augmentation of the edentulous atrophic anterior maxilla . METHODS Twenty-four subjects were enrolled in a r and omized , controlled , parallel-group , open-label clinical trial . Subjects either received rhBMP-2/ACS ( 1.5 mg/ml ) or particulated autogenous bone harvested from the m and ibular retromolar region . A titanium-mesh was used to provide space and wound stability . A guide was used to st and ardize clinical recordings using an analogue caliper . Alveolar ridge width was also assessed using cone-beam computed tomography . RESULTS rhBMP-2/ACS yielded significantly greater radiographic horizontal bone gain compared with autogenous bone graft at immediate subcrestal levels ( 1.5 ± 0.7 versus 0.5 ± 0.9 mm ; p = 0.01 ) ; non-significant differences were observed at mid- ( 2.9 ± 0.8 versus 2.9 ± 0.9 mm ; p = 0.98 ) and apical ( 1.7 ± 0.9 versus 1.8 ± 1.1 mm ; p = 0.85 ) crestal levels . No significant differences in clinical horizontal bone gain were observed at 6 months between rhBMP-2/ACS and autogenous bone graft ( 3.2 ± 0.9 mm versus 3.7 ± 1.4 mm ; p = 0.31 ) . Sixty-two implants were placed after 6 month of healing with no significant differences between groups for number of implants , implant size , primary stability and survival . CONCLUSIONS rhBMP-2/ACS appears a realistic alternative for augmentation of the edentulous atrophic anterior maxilla PURPOSE This phase II study was design ed to evaluate 2 concentrations of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) for safety and efficacy in inducing adequate bone for endosseous dental implant in patients requiring staged maxillary sinus floor augmentation . MATERIAL S AND METHODS Patients were treated with rhBMP-2 ( via an absorbable collagen sponge [ ACS ] ) , at concentrations of 0.75 mg/mL ( n = 18 ) , 1.50 mg/mL ( n = 17 ) , or with bone graft ( n = 13 ) . Bone induction was assessed by alveolar ridge height , width , and density measurements from computed tomography scans obtained before and 4 months after treatment and 6 months post-functional loading of dental implants ( density only ) . RESULTS Mean increases in alveolar ridge height at 4 months after treatment were similar among the groups ; 11.3 mm , 9.5 mm , and 10.2 mm , respectively , in the bone graft , 0.75 mg/mL , and 1.50 mg/mL rhBMP-2/ACS treatment groups . Mean increases in alveolar ridge width ( buccal to lingual ) at the crest of the ridge were statistically different among the treatment groups ; 4.7 mm , 2.0 mm , and 2.0 mm , respectively , in the bone graft , 0.75 mg/mL , and 1.50 mg/mL treatment groups ( P < or= .01 vs 0.75 mg/mL ; P < .01 vs 1.50 mg/mL ) . At 4 months postoperative new bone density was statistically different among the treatment groups ; 350 mg/cc , 84 mg/cc , and 134 mg/cc for the bone graft , 0.75 mg/mL , and 1.50 mg/mL rhBMP-2/ACS treatment groups , respectively ( P = .003 vs 0.75 mg/mL , P = .0137 vs 1.50 mg/mL , P = .0188 ; 1.50 mg/mL vs 0.75 mg/mL ) . Core bone biopsies obtained at the time of dental implant placement confirmed normal bone formation . The proportion of patients who received dental implants that were functionally loaded and remained functional at 36 months post-functional loading was 62 % , 67 % , and 76 % in the bone graft , 0.75 mg/mL , and 1.50 mg/mL rhBMP-2/ACS treatment groups , respectively . CONCLUSION This study is the first r and omized controlled trial demonstrating de novo organ tissue growth in humans from a recombinant human protein . rhBMP-2/ACS safely induced adequate bone for the placement and functional loading of endosseous dental implants in patients requiring staged maxillary sinus floor augmentation OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity In a multicenter , prospect i ve , r and omized , nonblinded , 2-year study , 279 patients with degenerative lumbar disc disease were r and omly divided into two groups that underwent interbody fusion using two tapered threaded fusion cages . The investigational group ( 143 patients ) received rhBMP-2 on an absorbable collagen sponge , and a control group ( 136 patients ) received autogenous iliac crest bone graft . Plain radiographs and computed tomographic scans were used to evaluate fusion at 6 , 12 , and 24 months after surgery . Mean operative time ( 1.6 hours ) and blood loss ( 109.8 mL ) were less in the investigational rhBMP-2 group than in the autograft control group ( 2.0 hours and 153.1 mL ) . At 24 months the investigational group 's fusion rate ( 94.5 % ) remained higher than that of the control group ( 88.7 % ) . New bone formation occurred in all investigational patients . At all intervals , mean postoperative Oswestry , back pain , and leg pain scores and neurologic status improved in both treatment groups with similar outcomes . In the control group , eight adverse events related to the iliac crest graft harvest occurred ( 5.9 % ) , and at 24 months 32 % of patients reported graft site discomfort and 16 % were bothered by its appearance . Lumbar fusion using rhBMP-2 and a tapered titanium fusion cage can yield a solid union and eliminate the need for harvesting iliac crest bone graft BACKGROUND Conventional dentoalveolar osseous reconstruction often involves the use of grafting material s 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 r and omized 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 r and omized , 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 BACKGROUND The U.S. Food and Drug Administration reported a higher incidence of cancer in patients who had spinal arthrodesis and were exposed to a high dose of recombinant human bone morphogenetic protein-2 ( rhBMP-2 )  compared with the control group in a r and omized controlled trial . The purpose of this study was to determine the risk of cancer after spinal arthrodesis with BMP . METHODS We retrospectively analyzed the incidence of cancer in 467,916 Medicare patients undergoing spinal arthrodesis from 2005 to 2010 . Patients with a preexisting diagnosis of cancer were excluded . The average follow-up duration was 2.85 years for the BMP group and 2.94 years for the control group . The main outcome measure was the relative risk of developing new malignant lesions after spinal arthrodesis with or without exposure to BMP . RESULTS The relative risk of developing cancer after  BMP exposure was 0.938 ( 95 % confidence interval [ 95 % CI ] : 0.913 to 0.964 ) , which was significant . In the BMP group , 5.9 % of the patients developed an invasive cancer compared with 6.5 % of the patients in the control group . The relative risk of developing cancer after BMP exposure was 0.98 in males ( 95 % CI : 0.94 to 1.02 ) and 0.93 ( 95 % CI : 0.90 to 0.97 ) in females . The control group showed a higher incidence of each type of cancer except pancreatic cancer . CONCLUSIONS Recent clinical use of BMP was not associated with a detectable increase in the risk of cancer within a mean 2.9-year time window . LEVEL OF EVIDENCE Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence 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 sample s 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 clinical ly stable at all assessment s 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 PURPOSE The purpose of this prospect i ve study was to evaluate the safety and effectiveness of recombinant human morphogenetic protein-2 ( rhBMP-2 ) on an absorbable collagen sponge ( ACS ) compared with an autogenous bone graft when used for 2-stage maxillary sinus floor augmentation . The study assessed new bone formation , placement integration , and functional loading after 6 months and long term for 2 years . MATERIAL S AND METHODS A total of 160 subjects were r and omized , enrolled , and followed from January 1999 to February 2004 at 21 centers in the United States . The subjects with less than 6 mm of native bone height were treated with 1.50 mg/mL rhBMP-2/ACS or with an autograft . The height and density measurements were quantified by computed tomography scans . Core biopsies were obtained at dental implant placement and used for histological analysis . Safety was evaluated by oral examinations , radiographs , serum chemistries , and hematology . RESULTS A significant amount of new bone was formed by 6 months postoperatively in each group . The mean change in bone height in the rhBMP-2/ACS subjects was 7.83 + /- 3.52 mm versus 9.46 + /- 4.11 mm for the bone graft subjects . At 6 months after dental restoration , the induced bone in the rhBMP-2/ACS group was significantly denser than that in the bone graft group . No marked differences were found in the histologic parameters evaluated between the 2 groups . The new bone was comparable to the native bone in density and structure in both groups . The success rate for the rhBMP-2/ACS group was 79 % ( 64 of 81 subjects ) , and 201 of 251 implants placed in the bone graft group and 199 of 241 implants placed in the rhBMP-2/ACS group were integrated , retained , and functional at 6 months after loading . No adverse events were deemed related to the rhBMP-2/ACS treatment . The autograft group was noted to have a 17 % rate of long-term parasthesia , pain , or gait disturbance related to the bone graft harvest . CONCLUSIONS The results of our multicenter , r and omized , prospect i ve , clinical trial have shown the effectiveness and safety of rhBMP-2/ACS compared with bone graft for sinus floor augmentation . The study 's primary endpoint was exceeded , and the implants placed in rhBMP-2/ACS and bone graft groups performed similarly after functional loading
PURPOSE Recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) is approved by the Food and Drug Administration as a viable alternative to bone graft in spinal fusion and maxillary sinus lift .
The research questions for meta- analysis were : Is rhBMP-2 an effective bone graft substitute in localized alveolar ridge augmentation and maxillary sinus floor augmentation ?
What are the potential adverse events ?