Bone Induction rhBMp2 PDF

ScienceDirect - Journal of Oral and Maxillofacial Surgery : De Novo hogenetic Protein-2 (rhBMP-2) in Maxillary Sinus Floor Augmentation
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PDF (391 K) doi:10.1016/j.joms.2005.08.018 Copyright 2005 American Association of Oral and Maxillofacial Surgeons Published by Elsevier Inc.
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Dental implant
De Novo Bone Induction by Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) in Maxillary Sinus Floor Augmentation
Philip J. Boyne DMD, MS, DSc , Leslie C. Lilly BSN, RN , Triplett DDS, PhD#
# Regents Professor and Chairman, Oral and Maxillofacial Surgery, Baylor College of Dentistry, ,
Cited By in Scopus (36)
, Robert E. Marx DDS ,
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Peter K. Moy DMD , Myron Nevins DDS , Daniel B. Spagnoli PhD, DDS and R. Gilbert
Texas A&M University System, Health Science Center, Dallas, TX.

Director of Implant Dentistry, University of California, Los Angeles, Los Angeles, CA.
Private Practice, University of Oral and Maxillofacial Surgery, Charlotte, NC.
Senior Director, Clinical Trial Operations, Wyeth Research, Cambridge, MA. Professor of Surgery and Chief, Division of Oral and Maxillofacial Surgery, Miller School of View Record in Scopus
Medicine, University of Miami, Miami, FL. Emeritus Professor, Department of Surgery, Oral and Maxillofacial Surgery Service, Loma Linda University Medical Center, Loma Linda, CA. Clinical Associate Professor, Harvard School of Dental Medicine, Swampscott, MA.
Available online 16 November 2005.
Purpose
This phase II study was designed 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.
Materials 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
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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 .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 randomized 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.
Article Outline
Materials and Methods Patient population Study design Surgical procedure Study material Efficacy evaluation Bone Induction Histology Crestal Bone Loss Adjacent to Dental Implants Factors affecting patient and dental implant success Patient success Dental implant success Dental implant survival Safety Immune response Statistical methods and analysis Results Study treatment Bone induction Bone Density Histology Exploratory Analysis Patient outcome Factors Which Could Affect Functional Loading Success Patient and dental implant success Bone Graft 0.75 mg/mL rhBMP-2/ACS Group 1.50 mg/mL rhBMP-2/ACS Crestal bone loss adjacent to dental implants Safety Immune Response Prevalence Incidence Discussion Acknowledgements References Patients with edentulous posterior maxillae often present with loss of alveolar bone and increased maxillary sinus pneumatization. As a result, dental restoration is often difficult to achieve because of an inadequate volume of bone to support placement of endosseous dental implants. Various surgical procedures have been developed to correct this problem. One of these is maxillary sinus floor augmentation. 1 and 2 In this procedure, alveolar bone height is increased by the formation of
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floor augmentation. 1 and 2 In this procedure, alveolar bone height is increased by the formation of bone in the lower third of the maxillary sinus. This allows for dental restoration specifically for the placement of endosseous dental implants. 3 Various bone grafting materials are currently being used in maxillary sinus floor augmentation procedures with different degrees of success. These materials include autogenous bone (harvested from the patients iliac crest, tibia, mandible, or maxillary tuberosities), allogeneic bone, bone graft substitutes (eg, xenografts), and a combination of these materials. However, all of these materials have limitations, including inconvenience, cost, and morbidity associated with harvesting bone from the iliac crest, inadequate supply when harvesting bone from the oral cavity, and delayed healing. Given these limitations, the ideal agent for maxillary sinus floor augmentation procedures has not yet been identified. The bone morphogenetic proteins (BMPs) are a family of osteoinductive proteins that stimulate endochondral and intramembranous bone formation from mesenchymal cells in situ. Urist,4 who showed ectopic bone formation in rabbits from implanted bone pieces, first described bone morphogenetic activity. Subsequently, several BMPs have been purified from bone, and many have been cloned providing tools to study the role of BMPs. 5, 6, 7 and 8 The availability of recombinant BMPs has permitted definitive tests of their osteoinductive activity in a variety of experimental systems, including several animal models of clinically relevant bone defects. 9 and 10 For example, in studies of dogs and non-human primates with large mandibular defects, rhBMP-2 induced rapid, new bone growth sufficient to heal the mandibular defects without the addition of bone graft. 11, 12 and 13 In addition, rhBMP-2/absorbable collagen sponge (ACS) successfully generated bone formation in goats that had undergone maxillary sinus floor augmentation procedures. 14 Based on these data and further preclinical studies showing the local and systemic safety and pharmacology of rhBMP-2, a clinical pilot study to determine the feasibility of using rhBMP-2 to induce de novo bone growth in patients who required 2-stage maxillary sinus floor procedures was conducted.15 In that study, 0.43 mg/mL rhBMP-2, administered via an ACS induced new bone growth in 100% of the 11 evaluable patients treated (mean gain, 8.51 mm; range, 2.3 mm to 15.7 mm). However, the quantity of bone formed was judged adequate for 73% of these individuals, suggesting that the concentration of rhBMP-2 or the total dose administered was too low and that higher concentrations should be evaluated. Consequently, we conducted a phase II randomized, parallel group evaluation of escalating concentrations of rhBMP-2 (0.75 and 1.5 mg/mL) compared with bone graft to determine a safe and effective concentration of rhBMP-2 for maxillary sinus floor augmentation procedures.
Materials and Methods

Patient population
Patients 18 years of age with inadequate alveolar bone height (less than 6 mm confirmed on computed tomography [CT] scan) in the posterior maxilla who were candidates for staged bilateral or unilateral maxillary sinus floor augmentation were eligible. All patients provided written informed consent. Patients were excluded if they had acute or chronic sinus disease; sinus pathology in a location that would interfere with postoperative radiographic measurements; significant untreated periodontal disease, caries, or oral infection; required onlay ridge augmentation to achieve adequate bone volume for placement of endosseous dental implants; used any nicotine-containing products within 2 weeks before surgery; were pregnant; had insulin-dependent diabetes; were taking medications or having treatments known to affect bone turnover; or had a disease that affects bone metabolism. Therapeutic agents or devices known to interfere with or to have an effect on bone induction were not permitted during the study period.
Study design
The primary objective for this phase II study was to evaluate the safety and efficacy of 2 concentrations of rhBMP-2 to induce adequate bone for endosseous dental implant placement (following a maxillary sinus floor augmentation procedure) to select 1 concentration for investigation in a future pivotal study. Secondarily, we wanted to estimate patient and dental implant success rates following 36 months of functional loading of dental implant(s) placed and loaded into the newly induced bone within the grafted sinus(s). Thus, this multicenter study was designed as a randomized, parallel evaluation of escalating concentrations (2) of rhBMP-2 as compared with bone graft. Bone graft was defined as the bone grafting material currently used at each investigative site. The materials that could be used were limited to autogenous bone or a
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each investigative site. The materials that could be used were limited to autogenous bone or a combination of autogenous bone and allogeneic bone. Six investigative sites were to enroll a total of 48 patients into 2 cohorts consisting of 24 patients each. Within each cohort, patients were to be randomized in a 2:1 ratio to receive either rhBMP2/ACS (16 patients) or bone grafting material (8 patients). Patients in the first cohort were to be treated with either rhBMP-2 at a concentration of 0.75 mg/mL or the bone grafting material. Patients in the second cohort were to receive either rhBMP-2 at a concentration of 1.50 mg/mL or bone grafting material. The 2 cohorts were to be treated sequentially; the second cohort was treated after demonstration of acute safety in the first cohort. Before randomization, patients were stratified based on dentate status (ie, totally or partially edentulous) to control for the possible confounding effect of this variable on functional loads placed onto a full arch prosthesis supported by dental implants as opposed to smaller units supported by dental implants. The patients treatment course was approximately 52 months in duration and was composed of several phases: short-term safety and bone induction (4 months), dental implant placement and osseointegration (initiated with the placement of dental implants and completed by prosthesis placement), and a 36 month functional loading phase. The patient was considered a treatment failure if he/she did not receive dental implants within 12 months postoperative and prosthetics within 24 months following dental implant placement. Oral examination, radiograph analysis, adverse event surveillance, measurement of vital signs, and evaluation of serum chemistry, hematology, and formation of antibodies to the study treatment monitored safety. The Institutional Review Board at each participating center approved the study protocol.
Surgical procedure
The surgical procedure and postoperative medications were standardized across the participating centers. Anesthesia was to include local infiltration with a mixture of epinephrine (not to exceed 1%) and lidocaine. The lateral surface of the maxilla was to be exposed by raising a mucoperiosteal flap by making an incision on the palatal or buccal surface of the alveolar ridge. A round bur or diamond was to be used to create an adequate window on the lateral maxillary wall. Patients in the rhBMP-2/ACS treatment group were to have had the bony window removed. The sinus membrane was to be elevated up the medial wall, but not stripped superiorly beyond the ostium. The study treatment (rhBMP-2/ACS or bone graft) was to be placed anteriorly and extended to the medial wall. The study treatment was not to be implanted if the sinus membrane was perforated and could not be overlapped onto itself. No concurrent extraneous materials, such as a barrier membrane, were to be used for the rhBMP-2/ACS treatment group. However, barrier membranes (of any type) could be used in the bone graft group, as determined by the operating surgeon. Medical illustrations and surgical photographs of the surgical procedure are provided in FIGURE 1 and FIGURE 2.
Full-size image (26K) FIGURE 1. Medical illustrations of surgical procedure implanting rhBMP-2/ACS. Boyne at al. Bone Induction With rhBMP-2. J Oral Maxillofac Surg 2005.
Full-size image (46K) FIGURE 2. Clinical photographs of surgical procedure implanting rhBMP-2/ACS. Boyne at al. Bone Induction With rhBMP-2. J Oral Maxillofac Surg 2005.
Study material
The rhBMP-2 was manufactured by Wyeth/Genetics Institute (Cambridge, MA) using recombinant DNA techniques. The ACS was derived from highly purified bovine tendon type I collagen and is marketed under the trade name Helistat Absorbable Collagen Hemostatic Agent (Integra Life Sciences, Plainsboro, NJ). rhBMP-2/ACS is now commercially available as Infuse Bonegraft through Medtronic Sofamor Danek (Medtronic, Memphis, TN).
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through Medtronic Sofamor Danek (Medtronic, Memphis, TN).
Efficacy evaluation
Bone Induction Bone induction was quantified by CT scans performed within 4 weeks before (baseline) and 4 months after implantation of rhBMP-2/ACS or bone graft. Measurement of the 4-month postoperative CT scan was performed first to establish points of measurement. These same reference points were then used to measure the baseline CT scan. The sites to be measured were determined by the investigators from the 4-month CT scan. This was achieved by the independent radiology center reformatting the 4-month CT scan and sending it to the investigator to identify the locations where the dental implants were to be placed. All measurements were then taken at these locations, which were within the sinus. Bone height, width, and density measurements were taken by the radiologists from one 2-mm thick, cross-sectional, multiplanar, reformatted image for each proposed endosseous dental implant site identified by the investigator, as determined on the 4-month CT scan. Measurements of the corresponding sites were then obtained from the baseline CT scans. Each measurement was made by 3 independent radiologists blinded to study treatment. Bone height was measured along a vertical line drawn from the alveolar crest to the floor of the maxillary sinus parallel to the plane of the planned endosseous dental implant site. The height measurement was taken from the level of the alveolar crest to the floor of the maxillary sinus (Fig 3). A patients bone height at baseline and at 4 months was reported as the average of the measurements taken by 3 independent radiologists of all the planned dental implant sites in the patient. The patients change in bone height following treatment was the 4-month height measurement minus the baseline height measurement.
Full-size image (19K) FIGURE 3. CT scan cross-section Linear measurements. Boyne at al. Bone Induction With rhBMP-2. J Oral Maxillofac Surg 2005.
To measure bone width, 3 horizontal lines were drawn perpendicular to the vertical line at 1/4, 1/2, and 3/4 of the distance from the alveolar crest to the maxillary sinus floor along the vertical axis of the height measurement line. Width measurements were taken at positions within the sinus where bone or nonmineralized bone occurred throughout the horizontal line. Width measurement was the distance between the medial and lateral borders of the bone on each of the 3 horizontal lines (Fig 3). The density of newly induced bone was assessed with the aid of a standard density block. Density of the treatment area was measured in 2 area of interest boxes excluding cortical bone. Newly induced bone density was the average of 3 independent bone density measurements at 4 months and was averaged over the 2 area of interest boxes of all planned dental implant sites (Fig 4).
Full-size image (20K) FIGURE 4. CT scan cross-section: Density measurements. Boyne at al. Bone Induction With rhBMP-2. J Oral Maxillofac Surg 2005.
Histology
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Full-thickness bone core biopsies of the study treatment area were obtained at the time of dental implant placement for those patients who received dental implants. Biopsies were taken by using a trephine (inner diameter 2.0, outer diameter 2.7) and drilling from the alveolar ridge toward the maxillary sinus in the intended dental implant position. The biopsies were fixed in neutral buffered 10% formalin, decalcified in formic acid, and processed and embedded longitudinally in paraffin. Blocks were cut at a thickness of 4 m and were stained with Mayers hematoxylin and eosin. An independent pathologist at ClinTrial BioResearch (Montreal, Canada) evaluated each biopsy, on a qualitative scale from 1 (small amount) to 5 (large amount), for the presence of cortical and/or trabecular bone, thickness of osseous trabeculae, and the presence of lamellar and woven bone. Bone cores were scored for osteoblasts and osteoclasts and were evaluated for evidence of pathologic change. Crestal Bone Loss Adjacent to Dental Implants Intraoral films were evaluated by 3 unique radiologists. They measured the distance, in millimeters, between the shoulder of the dental implant and the first contact of crestal bone to the implant (bone height) on both the mesial and distal sides. They also documented any abnormal findings around the dental implants (eg, over exuberant bone formation). To ensure that differences in measurements from visit to visit were caused by actual bone changes, the length of the dental implant from the implant apex to the implant shoulder was measured on the baseline image. This value was registered on the source document for each implant. On the follow-up radiographs the same distance was measured, and if the distance was 0.5 mm longer or shorter than the baseline, the follow-up image was corrected accordingly to match the implant length between the baseline and follow-up images. 16 These corrected images were used by 3 radiologists to perform the measurements. Crestal bone loss was reported as the average of the measurements taken by 3 independent radiologists. Factors affecting patient and dental implant success The time to dental implant and prosthesis placement was collected. Additional variables that could also affect dental implant success were recorded: topography of the alveolar ridge, whether crestal bone reduction was performed, quality of bone at the time of dental implant placement (ie, Branemark scale type I-IV), whether an additional onlay augmentation procedure was required for dental implant placement, manufacturer, rootform type, surface, and size of the dental implant placed. Patient success A patient was defined as having had a successful maxillary sinus floor augmentation procedure if he/she met the following criteria: had a maxillary sinus floor augmentation procedure; had dental implants (at least 1) placed into the grafted sinus (newly induced bone) without an additional maxillary sinus floor augmentation procedure; achieved osseointegration of a sufficient number of dental implants placed into the grafted sinus to allow placement of an implant borne prosthetic device; and maintained use of the prosthesis following functional loading. Dental implant success A dental implant was considered a success providing it was functionally loaded and met the following criteria: was immobile when tested clinically (providing it was unattached); did not have any evidence of continuous peri-implant radiolucency; and had no chronic symptoms of pain, infection, or neuropathies. Dental implant survival A dental implant was considered survived if it was not removed following its placement.
Safety
Safety was monitored by performing oral examinations, radiographs, monitoring for the occurrence of Adverse Events, and the collection of blood samples to measure serum chemistries, hematology, and antibody formation to the study treatment. Immune response
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Formation of antibodies to rhBMP-2, bovine type I collagen, and human collagen were assessed by enzyme-linked immunosorbent assay (ELISA). The samples were collected for antibody testing at baseline (before surgery), 1 and 4 months post surgery, and at an additional time point for those patients who had an elevated titer (> 50) at 4 months postoperative.
Statistical methods and analysis

Because this study was designed to evaluate the ability of a recombinant human protein to induce bone formation in patients following a maxillary sinus floor augmentation procedure, the patient rather than the dental implant was the primary unit of analysis. Therefore, all efficacy and safety analyses were performed for the intent-to-treat population, which included all enrolled patients in their respective randomized treatment groups. Analyses were performed using SAS (version 6.12; SAS, Chicago, IL) executed in a UNIX environment. Quantitative variables were summarized by treatment group and by visit using descriptive statistics. Qualitative variables were descriptively summarized by treatment group using counts and percentages. The denominator for calculating patient and dental implant success rates remained constant throughout the study, ie, the number of patients enrolled per treatment group, and the total number of dental implants placed (including replacements) remained unchanged. Patients (and their respective dental implants) who were discontinued from the study early because of treatment failure, their or the investigators request to terminate their participation early, or lost to follow-up where not removed from the denominator when calculating patient and dental implant success rates. For each quantitative variable, the distribution of the data was assessed using the Shapiro-Wilk test before further statistical testing. If the normality assumption was violated (P .1), then a nonparametric test (Kruskal-Wallis test) was used. All statistical testing was 2-sided and conducted at the 5% significance level, unless otherwise specified. Quantitative demographic variables were tested for baseline comparability among the 3 treatment groups using the F-test from an analysis of variance (ANOVA), while qualitative items were tested using the Pearsons chi-square test. An overall comparison of changes in bone measurements from baseline to 4 months postoperative among the treatment groups was carried out by ANOVA. If the overall P value was significant, then pairwise comparisons were carried out. Because of the small sample size statistical testing was not performed on the clinical outcome parameter.
Results
Forty-eight patients were enrolled between October 1996 and June 1997 at 6 centers in the United States: The Baylor College of Dentistry, Dallas, TX; Institute for Advanced Dental Studies, Swampscott, MA; Loma Linda School of Dentistry, Loma Linda, CA; Doctors Hospital at University of Miami, Coral Gables, FL; West Coast Center for Osseointegration, Los Angeles, CA; and University Oral and Maxillofacial Surgery, Charlotte, NC. The last patient completed the study in February 2002. Eighteen patients were treated with 0.75 mg/mL rhBMP-2/ACS, 17 patients were treated with 1.50 mg/mL rhBMP-2/ACS, and 13 patients were treated with standard bone graft material. Forty-one (85%) patients had bilateral and 7 (15%) patients had unilateral sinus procedures performed. At baseline, the mean alveolar ridge height was similar among the treatment groups and ranged from 5.0 to 6.2 mm. One patient from the bone graft group was enrolled in violation of the bone height requirement (< 6 mm). The demographic and baseline characteristics of the patients enrolled were similar among the 3 treatment groups (Table 1). Table 1. SUMMARY OF DEMOGRAPHIC VARIABLES BY TREATMENT GROUP
Bone Graft (n = 13) rhBMP-2/ACS 0.75 mg/mL (n = 18) rhBMP-2/ACS 1.50 mg/mL (n = 17) P Value
Variable Race (n/%) Caucasian Hispanic Other Gender (n/%) Male Female Currently use alcohol (n/%)
8 (62) 4 (31) 1 (8)
15 (83) 2 (11) 1 (6)
15 (88) 1 (6) 1 (6)
.3679
5 (38) 8 (62)
8 (44) 10 (56)
6 (35) 11 (65)
.9310
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No Yes Age (yrs) N (observed) Mean SD Weight (kg) N (observed) Mean SD Dentate Status N (observed) Partially edentulous Totally edentulous 9 (69) 4 (31) 13 (72) 5 (28) 10 (59) 7 (41) .7386 13 74.5 23.6 18 68.6 14.4 17 71.2 14.7 .6485 13 57 11 18 57 12 17 52 9 .3158 7 (54) 6 (46) 10 (56) 8 (44) 8 (47) 9 (53) .9345
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Full-size table Boyne at al. Bone Induction With rhBMP-2. J Oral Maxillofac Surg 2005. P values for discrete variables are from extended Fishers exact test.
P values for continuous variables are from Analysis of Variance F-test.
Study treatment
The volume of study treatment implanted depended on the estimated size of the patients sinus, the procedure type (ie, unilateral vs bilateral), and the surgical antral void created by the operating surgeon. The mean total volume of study treatment implanted per sinus was 6.9 cc, 11.9 cc, and 13.8 cc in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively. The mean total dose of rhBMP-2 implanted per sinus was 8.9 mg (range, 5.2 to 12.0 mg) for patients treated with 0.75 mg/mL and 20.8 mg (range, 10.8 to 24.0 mg) for patients treated with 1.50 mg/mL. The total rhBMP-2 dose implanted ranged from 6 to 24 mg and from 15 to 48 mg in the 0.75 and 1.50 mg/mL groups, respectively. In the standard bone graft group, 7 patients received autograft alone and 6 patients received autograft plus allograft. Autograft was harvested from the iliac crest (n = 4), the tibial plateau (n = 6), the chin (n = 1), or the maxilla (n = 2), and yielded 1 to 21 cc of bone.
Bone induction
At 4 months postoperative the mean bone height changes from baseline were 11.29 mm, 9.47 mm, and 10.16 mm in the 0.75 mg/mL rhBMP-2/ACS, 1.50 mg/mL rhBMP-2/ACS, and bone graft treatment groups, respectively. Patients in the bone graft group showed a slightly greater gain in bone height compared with the patients in the 2 rhBMP-2/ACS treatment groups; however, there were no significant differences between any of the treatment groups (P = .6074) (Table 2). Table 2. BONE HEIGHT AND WIDTH CHANGE AT 4 MONTHS POSTOPERATIVE BY TREATMENT GROUP
Bone Graft (n = 13) Height change (mm) N (observed) Mean SD 95% CI upper 95% CI lower Width change at 1/4 13 11.29 4.12 8.8 13.78 18 9.47 5.72 6.63 12.32 16 10.16 4.7 7.65 12.66 .6074 rhBMP-2/ACS 0.75 mg/mL (n = 18) rhBMP-2/ACS 1.50 mg/mL (n = 17)
P Value
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N (observed) Mean SD 95% CI upper 95% CI lower Width change at 1/2 N (observed) Mean SD 95% CI upper 95% CI lower Width change at 3/4 N (observed) Mean SD 95% CI upper 95% CI lower 13 10.56 3.17 8.64 12.47 18 11.86 5.15 9.29 14.42 16 10.78 4.63 8.31 13.25 .6822 13 10.17 2.98 8.37 11.97 18 8.54 5.47 5.82 11.26 16 7.8 3.87 5.74 9.86 .3468 13 4.66 2.75 3 6.32 18 2.02 2.73 0.67 3.38 16 1.98 2.41 0.69 3.27 .0130
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Full-size table Boyne at al. Bone Induction With rhBMP-2. J Oral Maxillofac Surg 2005. P value is from parametric ANOVA F-test.
Indicates the P value is less than .05.
Bone width at the crest of the ridge (1/4) increased significantly in the bone graft group (mean 4.66 mm) compared with the 2 rhBMP-2/ACS groups (mean 2.02 mm and 1.98 mm in the 0.75 mg/mL and 1.50 mg/mL rhBMP-2/ACS treatment groups, respectively (P .01 vs 0.75 mg/mL; P < .01 vs 1.50 mg/mL) (Table 2). The bone width at the midpoint of the treated sinus (1/2) also increased most notably in the bone graft group (mean, 10.17 mm) compared with the 2rhBMP-2/ACS groups (mean, 8.54 mm, 7.80 mm, respectively). However the difference among the treatment groups was not statistically significant (P = .3468) (Table 2). Bone width at the most apical end of the treated sinus (3/4) increased similarly among the treatment groups; mean values were 10.56 mm, 11.86 mm, and 10.78 in the bone graft, 0.75 mg/mL, and 1.50 mg/mL groups, respectively (P = .6822) (Table 2). Representative CT scan images of rhBMP-2/ACS and bone graft induced bone are shown in FIGURE 5 and FIGURE 6.
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ScienceDirect - Journal of Oral and Maxillofacial Surgery : De Novo hogenetic Protein-2 (rhBMP-2) in Maxillary Sinus Floor Augmentation

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Cited By in Scopus (36)

, Robert E. Marx DDS ,

Texas A&M University System, Health Science Center, Dallas, TX.

Private Practice, University of Oral and Maxillofacial Surgery, Charlotte, NC.

Available online 16 November 2005.

Materials and Methods

Materials and Methods

through Medtronic Sofamor Danek (Medtronic, Memphis, TN).

Statistical methods and analysis

8 (62) 4 (31) 1 (8)

15 (83) 2 (11) 1 (6)

15 (88) 1 (6) 1 (6)

P values for continuous variables are from Analysis of Variance F-test.

Indicates the P value is less than .05.

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