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Biomedical subjects

Marc L Nevins

Publications and source records attributed to Marc L Nevins.

10 recordsLinked to original sources

A new era in periodontal and periimplant regeneration: use of growth-factor enhanced matrices incorporating rhPDGF.

A new, powerful off-the-shelf wound healing and bone regeneration technology termed growth-factor enhanced matrix (GEM) has recently become available for clinical use. This graft material consists of a concentrated solution of pure recombinant human platelet-derived growth factor (rhPDGF-BB), the synthetic form of the body's key natural wound healing stimulator PDGF-BB, and an osteoconductive (bone scaffold) matrix. This is the first available purified, recombinant (synthetic) growth factor product and is the result of over a decade of extensive research. Clinical and animal study results with this graft material demonstrate that it is capable of simultaneously promoting wound healing, regeneration of bone, and acceleration of gingival attach-plent gain in challenging periodontal and periimplant defects.

Alveolar Bone Loss↗

Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial.

BACKGROUND: Growth factors are generally accepted to be essential mediators of tissue repair via well-established mechanisms of action that include stimulatory effects on angiogenesis and cellular proliferation, ingrowth, differentiation, and matrix biosynthesis. The aim of this study was to evaluate in a large-scale, prospective, blinded, and randomized controlled clinical trial the safety and effectiveness of purified recombinant human platelet-derived growth factor (rhPDGF-BB) mixed with a synthetic beta-tricalcium phosphate (beta-TCP) matrix for the treatment of advanced periodontal osseous defects at 6 months of healing. METHODS: Eleven clinical centers enrolled 180 subjects, each requiring surgical treatment of a 4 mm or greater intrabony periodontal defect and meeting all inclusion and exclusion criteria. Subjects were randomized into one of three treatment groups: 1) beta-TCP + 0.3 mg/ml rhPDGF-BB in buffer; 2) beta-TCP + 1.0 mg/ml rhPDGF-BB in buffer; and 3) beta-TCP + buffer (active control). Safety data were assessed by the frequency and severity of adverse events. Effectiveness measurements included clinical attachment levels (CAL) and gingival recession (GR) measured clinically and linear bone growth (LBG) and percent bone fill (% BF) as assessed radiographically by an independent centralized radiology review center. The area under the curve (AUC), an assessment of the rate of healing, was also calculated for CAL measurements. The surgeons, clinical and radiographic evaluators, patients, and study sponsor were all masked with respect to treatment groups. RESULTS: CAL gain was significantly greater at 3 months for group 1 (rhPDGF 0.3 mg/ml) compared to group 3 (beta-TCP + buffer) (3.8 versus 3.3 mm; P = 0.032), although by 6 months, this finding was not statistically significant (P = 0.11). This early acceleration of CAL gain led to group 1 exhibiting a significantly greater rate of CAL gain between baseline and 6 months than group 3 as assessed by the AUC (68.4- versus 60.1-mm weeks; P = 0.033). rhPDGF (0.3 mg/ml)-treated sites also had significantly greater linear bone gain (2.6 versus 0.9 mm, respectively; P < 0.001) and percent defect fill (57% versus 18%, respectively; P < 0.001) than the sites receiving the bone substitute with buffer at 6 months. There was less GR at 3 months in group 1 compared to group 3 (P = 0.04); at 6 months, GR for group 1 remained unchanged, whereas there was a slight gain in gingival height for group 3 resulting in comparable GR. There were no serious adverse events attributable to any of the treatments. CONCLUSIONS: To our knowledge, this study is the largest prospective, randomized, triple-blinded, and controlled pivotal clinical trial reported to date assessing a putative periodontal regenerative and wound healing therapy. The study demonstrated that the use of rhPDGF-BB was safe and effective in the treatment of periodontal osseous defects. Treatment with rhPDGF-BB stimulated a significant increase in the rate of CAL gain, reduced gingival recession at 3 months post-surgery, and improved bone fill as compared to a beta-TCP bone substitute at 6 months.

Adult↗

Three-dimensional micro-computed tomographic evaluation of periodontal regeneration: a human report of intrabony defects treated with Bio-Oss collagen.

This study utilized three-dimensional micro-computed tomography (micro-CT) to evaluate the regenerative response to Bio-Oss Collagen when used alone or in combination with a Bio-Gide bilayer collagen membrane for the treatment of four intrabony defects (5 to 7 mm) around single-rooted teeth. The micro-CT observations are compared to the clinical, radiographic, and histologic results, which have been previously reported. After reflecting a full-thickness flap, thorough degranulation and root planing were accomplished. Bio-Oss Collagen was then used to fill the defects, and in two cases a Bio-Gide membrane was placed over the filled defect. Radiographs, clinical probing depths, and attachment levels were obtained before treatment and immediately preceding en bloc resection of teeth and surrounding tissues 9 months later. A mean pocket depth reduction of 5.75 mm and mean clinical attachment level gain of 5.25 mm were recorded. The histologic evaluation demonstrated the formation of a complete new attachment apparatus with new cementum, periodontal ligament, and alveolar bone at the level of and coronal to the calculus reference notch. Micro-CT evaluation confirmed the histologic results and demonstrated the absence of ankylosis or root resorption for all specimens. This human histologic study demonstrated that Bio-Oss Collagen has the capacity to facilitate regeneration of the periodontal attachment apparatus when placed in intrabony defects. Micro-CT observations confirmed the histologic results and enhanced the three-dimensional understanding of periodontal wound healing. The results indicate that micro-CT may be useful for three-dimensional evaluation of periodontal regenerative procedures.

Animals↗

Osseous response following resective therapy with piezosurgery.

A piezoelectric instrument vibrating in the ultrasonic frequency range was investigated for its potential use in periodontal resective therapy. The rate of postoperative wound healing (baseline and 14, 28, and 56 days after surgery) in a dog model following surgical ostectomy and osteoplasty was the marker used to compare the efficacy of this instrument (PS) with a commonly used carbide bur (CB) or a diamond bur (DB). The surgical sites treated by CB or DB lost bone, in comparison to baseline measurements, by the 14th day, while the surgical sites treated by PS revealed a gain in the bone level. By day 28, the surgical sites treated by all three instruments demonstrated an increased bone level and regeneration of cementum and periodontal ligament. However, by day 56, the surgical sites treated by CB or DB evidenced a loss of bone, versus a bone gain in the PS-treated sites. Thus, it appears that PS provided more favorable osseous repair and remodeling than CB or DB when surgical ostectomy and osteoplasty procedures were performed. Therefore, PS could be regarded as being efficacious for use in osseous surgery.

Alveolar Bone Loss↗

Measuring the efficacy of rhBMP-2 to regenerate bone: a radiographic study using a commercially available software program.

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 standardized CT examinations and the Simplant program. The radiographic measurements were further refined by careful standardization 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.

Alveolar Bone Loss↗

Localized ridge augmentation/preservation. A systematic review.

BACKGROUND: Osseointegrated implants have been documented as efficacious, however, their placement may be contraindicated in some patients due to insufficient bone volume. Techniques such as guided bone regeneration (GBR), immediate implantation, and distraction osteogenesis (DO) have been utilized as ridge enhancement therapies. RATIONALE: This systematic review evaluates dental implant survival rates in patients treated with ridge augmentation or preservation techniques. FOCUSED QUESTION: In patients requiring dental implant placement, what is the effect of localized ridge preservation versus implant placement without augmentation on implant survival and adverse effects? SEARCH PROTOCOL: MEDLINE and Cochrane Oral Health Group Specialized Trial Register were searched. Hand searches were performed on Clinical Oral Implants Research, International Journal of Oral and Maxillofacial Implants, International Journal of Periodontics and Restorative Dentistry, Journal of Clinical Periodontology, Journal of Periodontology, and Journal of Periodontal Research. All searches were performed for articles published through April 2002. SELECTION CRITERIA: Publications reporting survival rate of dental implants following ridge therapy were included in the analysis. Reports describing techniques were excluded. DATA COLLECTION AND ANALYSIS: Due to the absence of controlled studies, a meta-analysis was not performed. Descriptive statistics are used to report the data. MAIN RESULTS: 1. A total of 18 studies were included: 13 reporting on guided bone regeneration (GBR, 1,741 patients) and 5 on distraction osteogenesis (DO, 92 patients). 2. There is a high level of predictable implant survival in sites treated by GBR or DO. 3. These survival rates are similar to those of implants placed in native bone. REVIEWERS' INTERPRETATIONS: Survival rates were similar for both GBR and DO implants. These survival rates were similar to implants placed in native bone.

Alveolar Ridge Augmentation↗

Periodontal regeneration in humans using recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and allogenic bone.

BACKGROUND: Purified recombinant human platelet-derived growth factor BB (rhPDGF-BB) is a potent wound healing growth factor and stimulator of the proliferation and recruitment of both periodontal ligament (PDL) and bone cells. The hypothesis tested in this study was that application of rhPDGF-BB incorporated in bone allograft would induce regeneration of a complete new attachment apparatus, including bone, periodontal ligament, and cementum in human interproximal intrabony defects and molar Class II furcation lesions. METHODS: Nine adult patients (15 sites) with advanced periodontitis exhibiting at least one tooth requiring extraction due to an extensive interproximal intrabony and/or molar Class II furcation defect were entered into the study. Eleven defects were randomly selected to receive rhPDGF-BB. Following full-thickness flap reflection and initial debridement, the tooth roots were notched at the apical extent of the calculus, the osseous defects were thoroughly debrided, and the tooth root(s) were planed/prepared. The osseous defects were then filled with demineralized freeze-dried bone allograft (DFDBA) saturated with one of three concentrations of rhPDGF-BB (0.5 mg/ml, 1.0 mg/ml, or 5.0 mg/ml). Concurrently, four interproximal defects were treated with a well accepted commercially available graft (anorganic bovine bone in collagen, ABB-C) and a bilayer collagen membrane. Radiographs, clinical probing depths, and attachment levels were obtained preoperatively (at baseline) and 9 months later. At 9 months postoperatively, the study tooth and surrounding tissues were removed en bloc. Clinical and radiographic data were analyzed for change from baseline by defect type and PDGF concentration. The histologic specimens were analyzed for the presence of regeneration of a complete new attachment apparatus coronal to the reference notch. RESULTS: The post-surgical wound rapidly healed and was characterized by firm, pink gingivae within 7 to 10 days of surgery. There were no unfavorable tissue reactions or other safety concerns associated with the treatments throughout the course of the study. In rhPDGF/allograft sites, the vertical probing depth (vPD) reduction for interproximal defects was 6.42 +/- 1.69 mm (mean +/- SD) and clinical attachment level (CAL) gain was 6.17 +/- 1.94 mm (both P < 0.01). Radiographic fill was 2.14 +/- 0.85 mm. Sites filled with ABB-C had a PD reduction and CAL gain of 5.75 +/- 0.5 and 5.25 +/- 1.71, respectively. Furcation defects treated with rhPDGF/allograft exhibited a mean horizontal and vertical PD reduction of 3.40 +/- 0.55 mm (P < 0.001) and 4.00 +/- 1.58 mm (P < 0.005), respectively. The CAL gain for furcation defects was 3.2 +/- 2.17 mm (P < 0.030). Histologic evaluation revealed regeneration of a complete periodontal attachment apparatus, including new cementum, PDL, and bone coronal to the root notch in four of the six interproximal defects and all evaluable (four of four) furcation defects treated with PDGF. Two of the four interproximal intrabony defects treated with ABB-C and membrane exhibited regeneration. CONCLUSIONS: Use of purified rhPDGF-BB mixed with bone allograft results in robust periodontal regeneration in both Class II furcations and interproximal intrabony defects. This is the first report of periodontal regeneration demonstrated histologically in human Class II furcation defects.

Adult↗

Evaluation of periodontal regeneration following grafting intrabony defects with bio-oss collagen: a human histologic report.

This study evaluated the clinical, radiographic, and histologic response to Bio-Oss Collagen when used alone or in combination with Bio-Gide bilayer collagen membrane for the treatment of four intrabony defects (5 to 7 mm) around single-rooted teeth. After reflecting a full-thickness flap, thorough degranulation and root planing were accomplished. In all cases, Bio-Oss Collagen was then used to fill the defects, and in two cases, a Bio-Gide membrane was placed over the filled defect. Radiographs, clinical probing depths, and attachment levels were obtained before treatment and immediately preceding en bloc resection of teeth and surrounding tissues 9 months later. Reduction in pocket depth and gain in clinical attachment level were observed for both treatment protocols. The histologic evaluation demonstrated the formation of a complete new attachment apparatus, evidencing periodontal regeneration that varied with defect morphology. This human histologic study demonstrated that Bio-Oss Collagen has the capacity to induce regeneration of the periodontal attachment apparatus when placed in intrabony defects.

Alveolar Bone Loss↗

Periodontal regeneration in human Class II furcations using purified recombinant human platelet-derived growth factor-BB (rhPDGF-BB) with bone allograft.

This human clinical trial evaluated the clinical and histologic response to recombinant human platelet-derived growth factor-BB (rhPDGF-BB) delivered in bone allograft for the treatment of advanced Class II furcation defects. Three mandibular and one maxillary molar furcation defects were treated: Two received 0.5 mg/mL and two received 1.0 mg/mL rhPDGF-BB, in all cases mixed with DFDBA. Clinical probing depths and attachment levels were obtained presurgically and 9 months postsurgical, after which the teeth and surrounding tissues were removed en bloc. Both concentrations of rhPDGF-BB resulted in substantially improved horizontal (mean 3.5 mm) and vertical (mean 4.25 mm) probing depths and attachment levels (mean 3.75 mm). Histologic evaluation revealed periodontal regeneration, including new bone, cementum, and periodontal ligament coronal to the reference notch. Regeneration was also present coronal to the original osseous crest In one case where an enamel projection extended into the fornix of the furcation, new calcified tissue with new inserting connective tissue fibers was observed over the enamel. This study documented the favorable tissue response to rhPDGF-BB treatment at both the clinical and microscopic levels, provided the first human histologic evidence that new calcified tissue with inserting collagen fibers can occur over enamel projections within furcations, and demonstrated for the first time that complete periodontal regeneration can be achieved in advanced Class II furcation defects using a combination of purified recombinant growth factor and bone allograft.

Adult↗