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In vivo degradation behavior of photo-cross-linked star-poly(epsilon-caprolactone-co-D,L-lactide) elastomers.

We have recently reported on the preparation of biodegradable elastomers through photo-cross-linking acrylated star-poly(epsilon-caprolactone-co-D,L-lactide). In this paper we assess the change in their physical properties during in vivo degradation in rats after subcutaneous implantation over a 12 week period. These parameter changes were compared to those observed in vitro. Two different cross-link densities were examined, representing the range from a high Young's modulus to a low Young modulus. Elastomers having a high cross-link density exhibited degradation behavior consistent with a surface erosion mechanism, and degraded at the same rate in vivo as observed in vitro. Young's modulus and the stress at break of these elastomers decreased linearly with the degradation time, while the strain at break decreased slowly. Elastomers having a low cross-link density exhibited a degradation mechanism consistent with bulk erosion. Young's modulus and the stress at break of these elastomers decreased slowly initially, followed by a marked increase in mechanical strength loss after 4 weeks. The elastomers were well tolerated by the rats over the 12 week period in vivo.

Absorbable Implants↗

The use of a bioresorbable nano-crystalline hydroxyapatite paste in acetabular bone impaction grafting.

Calcium phosphates such as TCP-HA granules are considered promising bone graft substitutes. In the future, they may completely replace allograft bone for impaction grafting procedures. Mechanically, acetabular reconstructions with TCP-HA granules show high stability, however this is partly caused by excessive cement penetration, which is unfavourable from a biological perspective. It has been hypothesised that mixtures of morselised cancellous bone grafts (MCB) and/or TCP-HA granules with a nano-crystalline hydroxyapatite paste (Ostim) may reduce cement penetration while maintaining adequate implant stability and biocompatibility of the graft mixture. To investigate this hypothesis, destructive lever-out tests and in vivo animal test were performed with various combinations of materials. Mechanically, the addition of 10% Ostim to mixtures of MCB and/or TCP-HA granules reduced cement penetration and resulted in a mechanical stability comparable to pure allograft (the current gold standard). Biologically, the application of Ostim with MCB or TCP-HA granules did not hamper the biocompatibility of the materials. Ostim was mostly osseous-integrated with MCB or TCP-HA granules after 8 weeks. Also, non-osseous-integrated Ostim remnants were observed. In tartrate resistant acid phosphatase stained sections, these few non-osseous integrated Ostim remnants were actively being resorbed by osteoclasts. In conclusion, Ostim HA-paste could be a valuable addition when TCP-HA ceramic granules are being used for acetabular bone impaction grafting procedures.

Absorbable Implants↗

Effect of varied release kinetics of the osteogenic thrombin peptide TP508 from biodegradable, polymeric scaffolds on bone formation in vivo.

This study was designed to assess the influence of varied release kinetics of the osteogenic thrombin peptide TP508 from osteoconductive poly(propylene fumarate)-based (PPF) composite scaffolds on bone formation in vivo. Four classes of scaffolds were constructed with different TP508 dosages (200, 100, or 0 microg) and release kinetics (large burst release, minimal burst release, or no release) and implanted in 15.0 mm segmental defects in rabbit radii. The animals were euthanized at 12 weeks and the implants were analyzed by light microscopy, histological scoring analysis, and histomorphometric analysis. Samples from all classes displayed bone growth within the pores of the scaffold near the edges of the defect. In areas where bone was not observed, the pores were filled with mostly fibrous tissue and exhibited minimal inflammatory response for all classes. In contrast to other scaffold classes, scaffolds containing a total dose of 200 microg TP508 and exhibiting a large burst release profile showed statistically more bone formation guided along the surface of the scaffold, with these scaffolds averaging 80% of the defect length bridged with bone compared to 10% or less bridged for the other scaffold classes. These results demonstrate that the extent of in vivo bone formation in response to controlled release from PPF-composite scaffolds is determined by the release kinetics of the incorporated osteogenic peptide.

Absorbable Implants↗

The effect of different mineral frames on ectopic bone formation in mouse hind leg muscles induced by native reindeer bone morphogenetic protein.

INTRODUCTION: Bone morphogenetic proteins (BMPs) require carrier material for slow release and framing material for osteoconduction. MATERIALS AND METHODS: The effect of a frame on early bone formation induced by partially purified native reindeer BMP in composite implants containing 3 mg of BMP, type IV collagen and tricalcium phosphate (TCP/Col/BMP) or hydroxyapatite (HA/Col/BMP) or biphasic tricalcium phosphate-hydroxyapatite (TCP/HA/Col/BMP) or biocoral (NC/Col/BMP) was evaluated using a mouse hind leg muscle pouch model. Collagen with native reindeer BMP (Col/BMP) and corresponding implants without native reindeer BMP served as controls. Evaluation was done by incorporation of 45Ca, radiographically and histologically 3 weeks after the implantation. RESULTS: None of the implants without native reindeer BMP were able to induce new bone visible on radiographs. The area of new bone formation in the Col/BMP (p=0.026) and TCP/HA/Col/BMP (p=0.012) groups was significantly greater than in the TCP/Col/BMP group. The optical density of the new bone area was significantly greater in the TCP/HA/Col/BMP group than in the TCP/Col/BMP (p=0.036) or Col/BMP (p=0.02) groups. 45Ca incorporation was many times greater in all the groups containing native reindeer BMP than in the corresponding groups without BMP. In the Col/BMP (p=0.046) and TCP/HA/Col/BMP (p=0.046) groups, 45Ca incorporation was significantly greater than in the TCP/Col/BMP group. No significant differences were found in any parameters between HA/Col/BMP and NC/Col/BMP groups and the other BMP-containing groups. CONCLUSIONS: Hydroxyapatite, biocoral and biphasic tricalciumphosphate-hydroxyapatite are equally good as framing material for native reindeer BMP, while tricalciumphosphate is somewhat worse. Osteoinduction of native reindeer BMP works well with collagen alone.

Absorbable Implants↗

In vivo experimental study on bone regeneration in critical bone defects using an injectable biodegradable PLA/PGA copolymer.

OBJECTIVES: An assessment was done of the bone-healing rate after implantation of a polylactide/polyglycolide copolymer (PLA-PGA) 50/50 dispersed in aqueous solution of PGA and dextran, used as bone substitutes in an animal model. STUDY DESIGN: Two groups of 5 rabbits each were used. In both the femoral condyles, a critical size defect of 6x10 mm was made. On the right side PLA/PGA was inserted; the left side remained empty. Thirty and 90 days after surgery the animals were killed. RESULTS: Defects left unfilled showed no spontaneous healing after 30 and 90 days. Sites filled with experimental materials showed new bone ranging between 11.46% and 76.82% after 30 days, and 75.98% and 95.34% after 90 days. Histomorphometry showed an increase in bone maturation between day 30 and 90 in experimental sites. At day 90, no statistical difference was seen as compared to normal bone. CONCLUSION: PLA/PGA copolymer dispersed in hydrosoluble matrix seems to be suitable as osteoconductive material in critical size defects.

Absorbable Implants↗

Biodegradable osteosynthesis material for stabilization of midface fractures: experimental investigation in sheep.

The most frequently tested biodegradable osteosynthesis materials have up to now largely consisted of poly-L-lactide (PLLA). The PLLA polymers appear to have sufficient mechanical strength for fracture treatment in the midface, but their degradation does not seem to be uniform enough to allow their clinical use. During the degradation process the disintegration products elicit a foreign body reaction due to non-uniform degradation rates. The foreign body reaction is sometimes combined with a fluctuant swelling at the implantation site. Implants injection-moulded from 90:10 PLLA/PGA (polyglycolic acid) have a more uniform degradation rate and seem to lead to a milder foreign body reaction. We bridged Le Fort I osteotomies in sheep using a system of injection-moulded PLLA/PGA 90:10 plates and screws and compared it with 2 mm AO miniplates and mini-screws made from titanium. Light microscopy evaluation showed that the PLLA/PGA copolymer system experienced its highest mechanical stress at the transition from screw head to screw shaft. Nevertheless, the fragments fixed with the copolymers were on the whole only slightly less stable than those fixed with the titanium system. The foreign body reaction solely due to co-polymer degradation was not severe, considering the fibrous tissue response that was found associated with the titanium components. The study does show that the copolymer investigated is adequate for clinical use as a biodegradable osteosynthesis material, at least in low stress bearing areas.

Absorbable Implants↗

Experimental study on in situ tissue engineering of the stomach by an acellular collagen sponge scaffold graft.

We carried out an experimental study to clarify the feasibility of stomach tissue engineering for reconstruction after partial gastrectomy. A collagen sponge scaffold was implanted to support the regeneration of stomach tissue. A 4 cm square area of the anterior wall of the stomach was surgically resected in three beagle dogs, and then reconstructed using the collagen sponge scaffold. The dogs received intravenous hyperalimentation for 14 days after the operation, and a silicone sheet was used as a patch on the luminal side to protect the scaffold from degradation by digestive juice. The silicone sheet was removed endoscopically 4 weeks after the operation, and the surgical defect was observed endoscopically at various time points. At 4 weeks after surgery, the stomach wall had regenerated, but was not yet covered by stomach mucosal tissue. However, at 16 weeks after surgery, mucosa totally covered the regenerated area. Microscopic findings confirmed regeneration of the stomach wall, mucosa, and thin muscular layer. These results show that tissue engineering of the stomach will be feasible in the near future for reconstruction after partial gastrectomy.

Absorbable Implants↗

[Bioartificial materials in urology].

The scope of our research is the development of polymer-based bioabsorbable stents for urologic applications and in vitro testing of tissue reactions of cultured ureteral and urethral segments induced by implanted polymer stent prototypes. For these purposes a tissue cultivation model was developed using selected techniques of tissue engineering. Essential advantages of degradable over nondegradable urethral stents are elimination of the adverse extraction of epithelialized stents and the potential for recovery of organ-specific functionality. Moreover, the biocompatibility of a degradable urethral stent could potentially reduce the risk of restenosis due to hyperplasia and could be used, even repeatedly, for the treatment of a number of subvesical obstructions. For the treatment of tumor-induced strictures, application of degradable polymer stents coated with cytostatic drugs may be possible. The mechanical effect of the drug-loaded stent as a "place holder" could be complemented by adjuvant or palliative approaches such as local chemotherapy. We have developed and tested in vitro a degradable urethral stent incorporated with the model drug methotrexate for local drug delivery (LDD) by diffusion and during stent degradation.

Absorbable Implants↗

Maxillary and mandibular osteosyntheses with PLGA and P(L/DL)LA implants: a 5-year inpatient biocompatibility and degradation experience.

BACKGROUND: This study consists of a 5-year experience with 413 maxillary and mandibular resorbable plate osteosyntheses focusing on clinically apparent foreign body reaction (i.e., swelling, osteolyses, and fistulation), indirect implant degradation (i.e., palpability and radiographic reossification), and direct implant degradation (i.e., molecular weight and crystallinity of explants). METHODS: Eighty fracture and reconstruction cases (32 female and 48 male patients, aged 1 to 83 years) were osteofixated with poly(L-lactide-co-glycolide) (PLGA) copolymer (n = 20) (139 PLGA osteosyntheses) or poly(L-lactide-co-DL-lactide) [P(L/DL)LA] (n = 60) [274 P(L/DL)LA osteosyntheses]. Local revisions (n = 30) were performed during secondary operations at 3, 6, 12, 18, or 24 months. Average clinical and radiographic follow-up lasted 29 months (range, 6 to 63 months). RESULTS: Five patients (6 percent) had apparent foreign body reactions, whereas 75 (94 percent) did not. One P(L/DL)LA mild reaction was effectively treated with cold packs and analgesics, one PLGA and three P(L/DL)LA medium severe reactions were treated with curettage, and one local osteolysis disappeared at 6 months. Implant palpability lasted 12 (PLGA) or 24 months [P(L/DL)LA]. The difference was significant (p < 0.000001). Burr holes reossified at 24 (PLGA) and 36 months [P(L/DL)LA] (p < 0.05). The 85:15 PLGA explants' initial 44,600 molecular weight decreased to 11,000 at 6 months; and scarce powdering granular residuals, too small for molecular weight assessment, were encountered at 12 months. The 70:30 P(L/DL)LA initial molecular weight of 45,000 decreased to 25,000 at 6 months and 8,000 at 18 months and to similar granules at 24 months (p < 0.02). Histology showed macrophages, giant cells, lymphocyte infiltration, little granulocytic infiltration, and minimal bleeding residuals. CONCLUSIONS: Both copolymers showed reliable biocompatibility and disintegration. Overall, 6 percent clinically apparent foreign body reactions were controlled conservatively and by local curettage; 85:15 PLGA degraded within 12 months and 70:30 P(L/DL)LA within 24 months, leaving powdering residual granules. Burr holes reossified 12 months later.

Absorbable Implants↗

In vivo evaluation of bioresorbable polylactide implants for cervical graft containment in an ovine spinal fusion model.

OBJECT: An in vivo study was conducted in an ovine model to investigate the biomechanical changes after the animals underwent single-level anterior cervical discectomy followed by fusion in which autologous tricortical graft was used and implantation of cervical plates for which bioresorbable polymer screws and plates were used. The specific aims of the study were to evaluate whether implant failure or screw backout would occur over time and to measure the change in stiffness at the treated level at various postoperative time periods (3, 6, and 12 months). METHODS: A total of 58 x-ray films were evaluated over the 12-month survival period. No screw breakage or displacement was observed in any animal during the temporal radiographic analysis. Radiographically confirmed fusion appeared to be complete at all time periods longer than 6 months. The biomechanical testing demonstrated dramatic reductions in range of motion at the fusion level in the animals allowed to survive for 6 and 12 months, indicating complete fusion after 6 months. CONCLUSIONS: The bioresorbable polymer cervical graft containment system appears to provide a safe and effective alternative for cervical fusion, and warrants further clinical evaluation for its use in single-level anterior cervical discectomy and fusion without postoperative orthosis.

Absorbable Implants↗

GTR treatment of intrabony defects with PLA/PGA copolymer or collagen bioresorbable membranes in combination with deproteinized bovine bone (Bio-Oss).

The objectives of this study were to evaluate the results of guided tissue regeneration (GTR) treatment of intrabony defects with two kinds of bioresorbable membranes, with deproteinized bovine bone (Bio-Oss) used as an adjunct. Twenty-eight patients with at least one intrabony defect with a probing pocket depth (PPD) >/=7 mm and radiographic evidence of an intrabony component (IC) >/=4 mm were randomly treated with either a polylactic/polyglycolic (PLA/PGA) acid copolymer or a collagen bioresorbable membrane combined with Bio-Oss implantation. Immediately prior to surgery (baseline) and after 1 year, the following parameters were recorded: (1) PPD, (2) gingival recession (REC), (3) probing attachment level (PAL), (4) presence/absence of plaque (PI), and (5) presence/absence of bleeding on probing (BOP). Occurrence of membrane exposure during healing and the smoking habits of the patients were also recorded. Statistical analysis was carried out using chi(2) -tests and t-tests. There were no significant differences between the two membrane groups regarding the clinical parameters at baseline. Statistically significant clinical improvements (PAL gains, reduced PPDs) were observed 1 year after treatment in both groups. There were no significant differences, however, between the PLA/PGA and the collagen membrane groups regarding any of the evaluated parameters (mean PAL gain: 2.9 mm vs 3.9 mm; mean residual PPD: 4.8 mm vs 4.1 mm, respectively). The membrane material per se does not seem to be a critical factor for the outcome of GTR treatment of intrabony defects with bioresorbable membranes.

Absorbable Implants↗

Clinical and radiographic evaluation, following delivery of fixed reconstructions, at GBR treated titanium fixtures.

Conditions following incorporation of fixed reconstructions, at endosseous titanium implants augmented at local bony dehiscence and fenestration defects using a bioabsorbable Resolut membrane were studied in 7 patients. Fixture stability, radiographic marginal bone levels and peri-implant soft tissue status were evaluated at 21 membrane treated and 17 control fixtures (installed in regions of adequate bone volume), following a 2-year period of functional loading. Prosthetic reconstructions were removed and clinical examination and Periotest values revealed that all fixtures were stable. All peri-implant soft tissues were clinically healthy. The mean probing depths at buccal sites for fixtures with original dehiscence (n = 10) and fenestration (n = 11) defects were 1.6 +/- 0.7 mm and 1.2 +/- 0.4 mm respectively. The control fixture group had a mean buccal probing depth of 1.4 +/- 0.6 mm. At abutment connection radiograph membrane treated fixtures had significantly lower marginal bone levels than control fixtures, indicating that optimal bone regeneration was not achieved at all defects. Mean radiographic bone loss 23-27 months following delivery of fixed reconstructions for original dehiscence and fenestration defect fixtures was 0.7 +/- 0.8 mm and 0.8 +/- 0.6 mm respectively at mesial surfaces, and 0.8 +/- 0.7 mm and 0.6 +/- 0.5 mm at distal surfaces. In the control fixture group a mean loss of 0.7 +/- 0.5 mm at mesial surfaces and 0.5 +/- 0.4 mm at distal surfaces was found. Results showed no significant difference in the rate of bone loss following functional loading between membrane treated and control fixtures.

Absorbable Implants↗

Poly-L/D-lactide (PLDLA) 96/4 fibrous implants: histological evaluation in the subcutis of experimental design.

Poly-L/D-lactide (PLDLA) 96/4 fibrous implants have been introduced to engineer functional fibrous constructions in situ. The current study was undertaken to evaluate the guidance of the fibrous tissue formation and the tissue reaction of porous PLDLA 96/4 scaffolds implanted in subcutaneous tissue. Three various PLDLA 96/4 knitted-mesh scaffolds (Loose, Ordinary, and Dense) were implanted subcutaneously in 32 rats, and followed-up from 3 days until 48 weeks postsurgery. Histological examination showed that PLDLA 96/4 scaffolds provided a structurally supporting element for 48 weeks. They were filled with fibrous tissue by 3 weeks. During the follow-up, loose connective tissue was organized into dense connective tissue with thick collagen bundles. At 48 weeks, no statistically significant difference was found in the amount of loose or dense connective tissue between the scaffold groups of various porosities, although the tendency for higher amounts of loose connective tissue was seen in the Loose type scaffolds. PLDLA filament diameters were 121 mum at 2 weeks, 119 mum at 24 weeks and 116 mum at 48 weeks (P = 0.03 between 2 and 48 weeks). Porous PLDLA scaffold induced fibrous tissue formation in situ. This can be exploited in engineering fibrous tissue constructs in vivo for tissue support or replacement purposes.

Absorbable Implants↗

An in-vivo model to interrogate the transition from acute to chronic inflammation.

This study describes the modulation of the rodent foreign body giant cell (FBGC) response to subcutaneously implanted, biodegradable poly(lactide-co-glycolide)/calcium phosphate (PLGA/CaP) composites by application of a thin surface coat of calcium phosphate. Macroporous PLGA/CaP composite scaffolds, with interconnecting macroporosity, were half coated with a 3mm thick layer of CaP by immersion in simulated body fluid. Half-coated scaffolds were implanted subcutaneously in the dorsum of male Wistar rats for 1, 4 and 8 weeks. Specimens were embedded in paraffin and tissue sections evaluated by light microscopy with particular reference to the FBGC response. Histomorphometry revealed that FBGCs were in contact with 6% (+/- 3.5%) of the uncoated half, at 1 week, but no FBGCs were seen on the coated half. By 4 weeks, FBGCs were seen on both the uncoated and coated halves of the scaffolds with 87% (+/-10%) and 36% (+/-4%) FBGC/polymer contact respectively. By 8 weeks these FBGC contact percentages had risen to 97% (+/-0.45%) in the case of the uncoated halves of scaffolds, but decreased to 22% (+/-4%) in the case of the CaP-coated halves. Thus the CaP coating abrogated the FBGC response to the underlying polymer. Such a model may prove useful in providing an experimental system whereby both the mechanisms of biocompatibility and the transition from acute to chronic inflammation could be interrogated.

Absorbable Implants↗

Augmentation of osteoinduction with a biodegradable poly(propylene glycol-co-fumaric acid) bone graft extender. A histologic and histomorphometric study in rats.

We investigated the feasibility of enhancing the regeneration of skeletal tissues by augmenting bone grafts with a composite biodegradable bone graft extender material based on the polymer poly(propylene fumarate), PPF. The material was mixed with autograft and allograft and placed directly into a cylindrical metaphyseal defect made in the rat tibia. These formulations were compared to defects without any graft material, autografts, allografts and PPF alone. Nine animals were included in each group. Animals were sacrificed at 1 and 4 weeks postoperatively. Implantation sites were then evaluated using histologic and histomorphometric methods. Results of this study showed that defects did not heal in sham operated animals. In the experimental groups, there was early new woven bone formation in the autograft group with near complete healing of the defect at four weeks. When PPF was used alone, gradual ingrowth of new bone was seen. Mixing of the PPF bone graft extender with either allograft or autograft material resulted in enhancement of new bone formation with both allo- and autograft. However, significantly more new bone formation than in the autograft group was only seen when the PPF bone graft extender was mixed with fresh autograft. Histomorphometry corroborated these findings. Results of this study suggest that a PPF-based material may be used to increase the volume of smaller amounts of bone grafts supporting the concept of "bone graft extenders" by application of engineered biodegradable porous scaffolds.

Absorbable Implants↗

The complete process of bioresorption and bone replacement using devices made of forged composites of raw hydroxyapatite particles/poly l-lactide (F-u-HA/PLLA).

Here we document the complete process of bioresorption and bone replacement of rods made of forged composites of unsintered hydroxyapatite particles/poly l-lactide (F-u-HA/PLLA) implanted in the femoral medullary cavities of rabbits. Bioresorption, osteoconductive bioactivity and bone replacement were compared in three implantation sites. In the first site, the end of the rod was located near the endosteum in the proximal medullary cavity. In the second, the rod was located at the centre of the bone marrow space without contacting the endosteum. In the third, the rod was in direct contact with cancellous bone within the distal femoral condyle. Micro-computerised tomography, scanning electron microscopy and photomicrographs of stained sections were used to document the complete process of bioresorption and bone replacement. At the first implantation site, the rod was completely resorbed and unbound u-HA particles were detected in and around the endosteum 5-6 years after implantation. At the second site, the rod showed significant shrinkage 4-5 years after implantation due to the release of almost all the PLLA, although a contracted cylindrical structure containing a few u-HA persisted even after approximately 6 years. At the third site, u-HA particles were almost completely replaced with bone after 5-6 years. Conversely, PLLA-only rods showed little bone conduction, and small amounts of degraded PLLA debris and intervening some tissue persisted even after long periods. Namely, the u-HA/PLLA composites were replaced with bone in the distal femoral condyle, where they were in direct contact with the bone and new bone formation was anatomically necessary. By contrast, composite rods were resorbed without replacement in the proximal medullary cavity, in which new bone growth was not required. We therefore conclude that the F-u-HA30/40 composites containing 30 wt%/40 wt% u-HA particles are clinically effective for use in high-strength bioactive, bioresorbable bone-fixation devices with the capacity for total bone replacement.

Absorbable Implants↗

Role of the cross-linking enzyme tissue transglutaminase in the biological recognition of synthetic biodegradable polymers.

The calcium-dependent cross-linking enzyme tissue transglutaminase (tTgase, type II) is a potential novel player at the cell surface, where its contribution to cell adhesion and stabilization of the extracellular matrix is becoming increasingly recognized. We investigated whether tTgase enhances the biological recognition of poly (DL lactide co-glycolide) (PLG), poly (epsilon-caprolactone) (PCL), and poly (L lactide) (PLA), biomaterials widely used in medical implants. Three cell-model systems consisting of human osteoblasts, endothelial cells (ECV-304), and Swiss 3T3 fibroblasts were utilized, in which tTgase expression was modulated by gene transfer, and the ability of cells to spread on these polymers was quantified in relation to the altered level of expressed tTGase. Results show that over-expression of tTgase in human osteoblasts positively correlated with cell spreading on PLG, while no attachment and spreading was found on PCL and PLA. Antisense silencing of tTgase in the endothelial cells led to a marked reduction of cell spreading on all polymers. The hydrophobic nature of PLC also appeared to favor endothelial cell attachment. Spreading of Swiss 3T3 fibroblasts on these biomaterials was only slightly affected by increased expression of tTgase, although cell spreading on control glass was increased. We propose that the consideration of tTgase-mediated bioactivity in novel biomaterials may improve cell attachment and promote biocompatibility.

3T3 Cells↗

Guided bone regeneration using demineralized laminar bone sheets versus GTAM membranes in the treatment of implant-associated defects. A clinical and histological study.

This study was designed to compare the regenerative potential at dehisced implant sites of the resorbable demineralized laminar bone sheets and non resorbable GTAM membranes. Twenty-six standard screw-type fixtures showing buccal dehiscences in 7 patients were treated using the GBR principles and received either laminar bone sheets (experimental) or GTAM (control) membranes. Twelve experimental and 10 control sites were available for evaluation at second stage surgery carried out 8 months following implant placement. Height and maximum width of the dehiscence defects were measured at the time of implant insertion and at second-stage procedure. Mean percentage of defect fill was 75.17% in the experimental dehiscences versus 86.70% in the control defects. A statistically significant difference in the percentage of defect fill could not be evidenced between the two treatment modalities. Complete fill was observed in 25% of the experimental versus 70% of the control sites. A significant difference was found in the median Density Index with the GTAM group showing a consistency similar to bone in a larger number of sites. Histologically, material with the same staining features of bone was evidenced inside the GTAM membranes in 3 cases while newly-formed bone was present in all instances under the control GTAM barriers. In the laminar bone-treated sites, the membrane maintained its integrity in almost all cases. Newly formed bone was found underlying the membrane in cases with a Density Index of 5 with no evidence of bony tissue adhering to the laminar sheets.

Absorbable Implants↗