Matrix Graft Research Articles

Regenerating Alveolar Bone for Implant Placement: The Efficacy of Autogenous Mineralized Dentin Matrix—A Systematic Review and Meta-Analysis

The preservation of the alveolar ridge has gained increasing importance for various types of rehabilitation, including dental implant placement. Consequently, researchers have explored different bone grafts, such as mineralized dentin matrix grafts. However, a comprehensive review of the efficacy of autogenous mineralized dentin (AMD) for alveolar ridge preservation remains lacking. In this review, we evaluated the efficacy of AMD as a method for alveolar ridge preservation in cases of delayed implant placement. A comprehensive search through PubMed, Google Scholar, Cochrane Library, and B-on repositories was conducted without time constraints up to July 2024 to identify peer-reviewed human studies. These studies assessed the percentage of newly formed bone and residual graft following bone regeneration with AMD grafts after tooth extraction, specifically in the context of delayed implant placement. Our analysis included four selected studies involving 55 patients and 67 sockets. The findings suggest that AMD grafts resulted in an average (and 95% confidence interval) of 43.8% [36.6%, 50.8%] newly formed bone, and delayed implant placement was a feasible surgical option for all patients. Although the available literature is scarce, AMD grafting has yielded promising outcomes as a method for bone reconstruction. Nevertheless, additional randomized controlled trials with larger sample sizes and longer follow-ups are required to substantiate these findings.

Comparison of autologous venous grafts and three types of extracellular matrix grafts in Peyronie's disease surgery.

Peyronie's disease (PD) is known as a wound-healing disorder for which surgery remains the gold-standard treatment, but studies comparing graft materials are limited in the literature. The aim of this study was to evaluate the mid- and long-term results of patients who underwent surgery for PD with grafting procedures performed by a single experienced surgeon according to graft materials. Patients who underwent corporoplasty between 2014 and 2020 with grafting procedures performed by a single experienced surgeon were retrospectively reviewed. A total of 115 patients were divided into 4 groups according to the grafting material used: autologous saphenous venous grafts, Group 1 (n = 36); porcine pericardial extracellular matrix grafts (EMGs; XenoGuard, MBP Medical Biomaterial Products GmbH, Neustadt-Glewe, Germany), Group 2 (n = 40); porcine intestinal submucosal EMGs (BioDesign, Cook Medical, Bloomington, IN, USA), Group 3 (n = 36); and bovine pericardial EMGs (Tutopatch, Tutogen Medical, Inc., Alachua, FL, USA), Group 4 (n = 43). The mean operation time for Group 1 was longer than that of the other groups (p < 0.001). When comparing the groups in pairs, it was observed that the duration of postoperative loss of sensation (LOS) was significantly shorter in Group 3 (12.3 ± 5.3 days) and Group 4 (15.1 ± 3.1 days) (p < 0.05). There was a statistically significant difference between Groups 1 and 4 in penile length loss when the groups were compared in pairs (p = 0.017). There was a statistically significant difference between patients with penile curvatures of 0° to 59° and patients with curvatures of ≥60° in terms of duration of postoperative LOS (14.4 ± 5 vs. 16.4 ± 5.8 days, respectively; p = 0.028) and penile length loss (2.6 ± 5 vs. 5.7 ± 6.8 mm, respectively; p = 0.002). The findings suggest that EMGs should be preferred to autologous venous grafts due to reduced postoperative erectile dysfunction, shorter operation time, and shorter recovery time for LOS.

A multicentre clinical trial evaluating the outcomes of two application regimens of a unique keratin-based graft in the treatment of Wagner grade one non-healing diabetic foot ulcers.

Diabetic foot complications that lead to lower extremity amputations pose a significant challenge to the entire global health system. In this multicentre clinical trial, 26 patients with chronic Wagner one diabetic foot ulcers (DFUs) were treated with a unique human keratin matrix graft applied either weekly or bi-weekly, in addition to standard of care. The hypothesis was that bi-weekly application would be similar to weekly application. The primary endpoint was complete wound closure by 12 weeks, and secondary endpoints included healing time, percent area reduction and weekly changes in peripheral neuropathy, pain and quality of life. In the intent-to-treat population, 77% (10/13) of DFUs treated with bi-weekly application healed compared with 69% (9/13) treated with weekly application. The mean time to heal within 12 weeks in the bi-weekly group was 61 days and in the weekly group was 54 days. The mean percent area reduction at 12 weeks was 94.7% in the bi-weekly group compared with 84.8% in the weekly group. The number of grafts used in the bi-weekly group was 3.9 compared with 6.2 in the weekly group. The results of this trial confirm our hypothesis that whether bi-weekly or weekly application of the unique keratin matrix graft is used to treat nonhealing indolent DFUs, there is a high rate of complete healing. Based on these results, future studies should be conducted that further investigate the use of this novel human keratin matrix graft for the treatment of chronic DFUs.

Combined use of composite mesh and acellular dermal matrix graft for abdominal wall repair following tumour resection

BackgroundSurgeries for sarcomas in the abdominal wall require wide resections, often radical en bloc resections, which generate major defects involving a very complex repair. The combined use of porcine dermal xenografts, together with composite meshes, may assist in the repair of these defects with minimal complications.MethodWe present a series of 19 patients (10 males and 9 females), with a mean age of 53.2 years (range: 11–86 years) treated in the Sarcoma Unit of the Virgen de la Arrixaca University Hospital from January 2015 to December 2021. Histopathologically, there were four chondrosarcomas (21%), three Ewing sarcomas (15.7%), two desmoid tumours (10.5%), two undifferentiated pleomorphic sarcomas (10.5%), two well-differentiated liposarcomas (10.5%), two leiomyosarcomas (10.5%), one synovial sarcoma, one dermatofibrosarcoma protuberans, one fibromyxoid sarcoma (or Evans tumour), and one metastasis from an adenocarcinoma of unknown origin. All the patients were resected following surgical oncology principles and reconstructed by means of the combined use of a composite mesh acting as a neoperitoneum and a porcine dermal xenograft acting as an abdominal neofascia.ResultsThe mean size of the defects generated after surgery for tumour excision was 262.8 cm2 (range: 150–600 cm2). After a mean follow-up of 38 months, six patients (31.5%) developed complications—two cases of wound dehiscence, one case of surgical wound infection, one case of graft partial necrosis, one case of anastomotic leak and one death due to multiorgan failure secondary to massive bronchoaspiration.ConclusionSurgeries for sarcomas of the abdominal wall require wide oncological resections, which generate major abdominal wall defects. The repair of these defects by means of the combined use of synthetic and biological meshes is a technique associated with minimal complications and excellent medium-term results.

Advances in autogenous dentin matrix graft as a promising biomaterial for guided bone regeneration in maxillofacial region: A review.

Autogenous dentin matrix (ADM), derived from a patient's extracted tooth, can be repurposed as an autologous grafting material in reconstructive dentistry. Extracted teeth provide a source for ADM, which distinguishes itself with its low rejection rate, osteoinductive capabilities and ease of preparation. Consequently, it presents a viable alternative to autogenous bone. Animal studies have substantiated its effective osteoinductive properties, while its clinical applications encompass post-extraction site preservation, maxillary sinus floor augmentation, and guided bone tissue regeneration. Nevertheless, the long-term efficacy of ADM applied in bone regeneration remains underexplored and there is a lack of standardization in the preparation processes. This paper comprehensively explores the composition, mechanisms underlying osteoinductivity, preparation methods, and clinical applications of ADM with the aim of establishing a fundamental reference for future studies on this subject.

Initial experience with ovine forestomach matrix graft for glossectomy defect reconstruction: A case series

Soft tissue reconstruction of oral cavity defects, such as glossectomy defects secondary to malignancy, pose a challenge for head and neck, oral, and maxillofacial surgeons. Reconstruction options for mucosal defects include primary closure, healing by secondary intention, full mucosal and split-thickness skin grafts, pedicled flaps, and microvascular free flaps. Biological grafts have become an integral part of the modern reconstructive ladder and are widely used for the regeneration of various soft tissue defects, including oral defects. This case series describes our initial experience using ovine forestomach matrix grafts in tongue and oral cavity reconstruction. Oral reconstruction using ovine forestomach matrix grafts was undertaken on three patients post wide excision and resulted in good functional and cosmetic outcomes. The rate of tissue formation provided by the graft and the grafts’ relative resistance to the hostile environment of the oral cavity support further clinical research to validate the use of these devices in oral reconstruction.

The value of perforator flap reconstruction in painful soft tissue calcifications

Soft tissue calcifications frequently cause debilitating pain and functional impairments, considerably affecting patients’ quality of life. As they are rare entities, evidence remains sparse, especially regarding treatment effectiveness and recurrence rates. While both pharmacological and surgical treatments may alleviate symptoms, complete resection is currently believed to prevent long-term recurrence of deposits. To improve understanding and raise awareness for soft tissue calcifications, the goal of this study was to review the current state of treatment and to compare benefits and possibilities of flap reconstruction versus simple excision in improving quality of life. Furthermore, we include a successful case report of complete resolution of symptoms following quadruple perforator flap reconstruction. By systematic literature review, studies published in MEDLINE between 1980 and 2024 reporting on surgical treatment and outcome of soft tissue calcifications were included, in addition to a detailed description of our case report. A total of 53 studies reporting on 197 patients with soft tissue calcifications were included. Simple surgical excision was the most commonly (85.9%) employed procedure, demonstrating a substantial recurrence rate of 13.3%. In contrast, no patients who underwent radical excision experienced recurrence. Dermal matrix grafts and flap reconstruction were successfully used in patients requiring substantial tissue coverage, highlighting their value in complex defect reconstruction following radical excision. The combination of complete surgical resection and flap reconstruction reduces recurrence rates and improves postoperative outcomes and quality of life of these patients, supporting early radical surgical intervention as the gold standard treatment for soft tissue calcifications.

Clinical efficacy of two vertical soft tissue augmentation techniques for peri-implant crestal bone level stability: A randomized clinical trial.

This study aimed to compare the efficacy of two techniques-acellular dermal matrix (ADM) grafting and tenting technique (TT)-for soft tissue height (STH) augmentation simultaneous to implant placement to minimize peri-implant crestal bone level (CBL) changes. Forty patients with a healed single mandibular posterior edentulous site with a thin soft tissue phenotype were enrolled. Twenty patients received simultaneously to implant placement ADM grafting, while the others received submerged healing abutment (TT). Clinical peri-implant soft tissue height and radiographic CBL changes were measured at restoration delivery and 1-year follow-up. Both techniques effectively increased soft tissue thickness, resulting in a final average STH of 3.4 ± 0.5 mm after augmentation. On average, soft tissue increased by 1.6 ± 0.5 mm in group ADM and by 1.8 ± 0.4 mm in group TT after augmentation. In Group ADM, mesial CBL decreased from 0.4 ± 0.3 mm to 0.1 ± 0.2 mm, and distal CBL decreased from 0.5 ± 0.3 mm to 0.2 ± 0.3 mm over 1 year. In Group TT, mesial CBL remained stable at 0.3 ± 0.2 mm, while distal CBL reduced slightly from 0.5 ± 0.5 mm to 0.3 ± 0.2 mm. Both groups showed minimal changes in CBL, indicating great stability (pmesial = 0.003, pdistal = 0.004). TT was particularly effective in preventing mesial bone loss (pmesial = 0.019). The mesial CBL changes significantly differed between groups (p = 0.019), and not significantly at distal sites (p = 0.944). Neither treatment exhibited significant bone remodeling below the implant shoulder. This study suggests that both techniques were successful in STH augmentation, and they may effectively reduce peri-implant crestal bone level changes, with TT being slightly superior. TT was more prone to post-surgical complications. This RCT was not registered before participant recruitment and randomization.

Decellularized Matrices for the Treatment of Tissue Defects: from Matrix Origin to Immunological Mechanisms.

Decellularized matrix transplantation has emerged as a promising therapeutic approach for repairing tissue defects, with numerous studies assessing its safety and efficacy in both animal models and clinical settings. The host immune response elicited by decellularized matrix grafts of natural biological origin plays a crucial role in determining the success of tissue repair, influenced by matrix heterogeneity and the inflammatory microenvironment of the wound. However, the specific immunologic mechanisms underlying the interaction between decellularized matrix grafts and the host immune system remain elusive. This article reviews the sources of decellularized matrices, available decellularization techniques, and residual immunogenic components. It focuses on the host immune response following decellularized matrix transplantation, with emphasis on the key mechanisms of Toll-like receptor, T-cell receptor, and TGF-β/SMAD signaling in the stages of post-transplantation immunorecognition, immunomodulation, and tissue repair, respectively. Furthermore, it highlights the innovative roles of TLR10 and miR-29a-3p in improving transplantation outcomes. An in-depth understanding of the molecular mechanisms underlying the host immune response after decellularized matrix transplantation provides new directions for the repair of tissue defects.

634 Biodegradable Temporising Dermal Matrix Graft for Open Foot Wounds, an Audit from a Tertiary Vascular Unit

634 Biodegradable Temporising Dermal Matrix Graft for Open Foot Wounds, an Audit from a Tertiary Vascular Unit

Comparison of the efficacy of tricalcium phosphate and mineralized plasmatic matrix graft for the bone defect in the distal second molar tooth after surgery of the lower impacted third molar tooth

Aim: After the extraction of mandibular horizontal and mesioangular teeth, a defect occurs in the distal part of the second molar. In this study, the effect of MPM on these defects was evaluated. Materials and methods: 36 patients randomly divided into 3 groups. The first group included MPM and PRF. The second group included B-tcp and PRF. In the 3rd group, the extraction socket was left empty. At preoperative and postoperative 6th months, periodontal pocket depth, gingival index and plaque index, and the distance between the enamel junction and crestal bone at the distal of the 2nd molar were measured by CBCT. 8 patients were removed for various reasons. 28 patients were evaluated. Results: Preoperative and postoperative periodontal pocket depths at the sixth month were 7.67 ± 1.58 mm and 4.67 ± 1.23 mm in the MPM group (p&lt;0.001); 6.60±1.96 mm and 4.70±1.34 mm in the β-TCP group (p&lt;0.001); 6.78±1.48 mm and 5.56±1.01 mm in the control group (p&lt;0.023). Bone defects preoperatively and at six months postoperatively were 7.97 ± 1.04 mm and 3.59 ± 0.66 mm in the MPM group (p&lt;0,001); 6.23 ± 1.37 mm and 2.90 ± 1.04 mm in the β-TCP group (p&lt;0.001); 6.92±0.82 mm and 4.30±0.68 mm in the control group (p&lt;0.001). Conclusion: MPM is an effective graft material to restore the periodontal health of the distal part of the second molar after impacted lower third molar surgery

Varying Properties of Extracellular Matrix Grafts Impact Their Durability and Cell Attachment and Proliferation in an In Vitro Chronic Wound Model

While acute wounds typically progress through the phases of wound healing, chronic wounds often stall in the inflammatory phase due to elevated levels of matrix metalloproteinases (MMPs) and proinflammatory cytokines. Dysregulated expression of MMPs can result in the breakdown of extracellular matrix (ECM) formed during the wound healing process, resulting in stalled wounds. Native collagen-based wound dressings offer a potential wound management option to sequester excess MMPs and support cellular interactions that allow wound progression through the natural healing process. Herein, we utilized commercially available ECM matrices, two derived from porcine small intestinal submucosa (PCMP, 2 layers; PCMP-XT, 5 layers) and one derived from propria submucosa (ovine forestomach matrix, OFM, 1 layer), to demonstrate the impact of processing methodologies (e.g., layering and crosslinking) on functional characteristics needed for the management of chronic wounds. Grafts were evaluated for structural composition using scanning electron microscopy and histology, ability to reduce MMPs using fluorometric assays, and durability in an in vitro degradation chronic wound model. Both intact (nondegraded) and partially degraded grafts were assessed for their ability to serve as a functional cell scaffold using primary human fibroblasts. Grafts differed in matrix substructure and composition. While all grafts demonstrated attenuation of MMP activity, PCMP and PCMP-XT showed larger reductions of MMP levels. OFM rapidly degraded in the in vitro degradation model (&lt;3 hours), while PCMP and PCMP-XT were significantly more durable (&gt;7 days). The ability of PCMP and PCMP-XT to serve as scaffolds for cellular attachment was not impacted by degradation in vitro. Three ECM grafts with varying structural and functional characteristics exhibited differential durability when degraded in a simulated chronic wound model. Those that withstood rapid degradation maintained their ability to function as a scaffold to support attachment and proliferation of fibroblasts, a cell type important for wound healing.

Efficacy of acellular xenogeneic dermal matrix graft in the treatment of multiple gingival recessions: systematic review and meta-analysis.

This study aimed to compare the efficacy of acellular xenogeneic dermal matrix graft (AXDM) compared to connective tissue graft (CTG) in treating multiple gingival recessions. A systematic search of electronic databases was conducted to identify randomized clinical trials (RCTs) that compared AXDM and CTG. The selected studies were subjected to bias risk assessment, data extraction, and meta-analyses. Parameters such as gingival recession height, width, mean percentage of root coverage, and complete root coverage were analyzed. Seven RCTs involving 146 patients were included. The meta-analyses indicated that CTG was statistically superior to AXDM in reducing gingival recession height at the final follow-up (mean difference: -0.104mm, 95% confidence interval [CI]: -0.180-0.028, p = 0.008) and width at the final follow-up (mean difference: -0.285mm, 95% CI: -0.541-0.030, p = 0.029). CTG also demonstrated a significantly higher mean percentage of root coverage at the 6-month follow-up (difference in means: -2.761mm, 95% CI: -4.932-0.590, p = 0.013) and a higher percentage of complete root coverage at the 6-month follow-up (odds Ratio [OR]: 0.598, 95% CI: 0.4-0.892, p = 0.012) compared to AXDM. However, there was no significant difference in the number of teeth with complete root coverage between CTG and AXDM (OR: 1.610, 95% CI: 0.983-2.636, p = 0.058) and aesthetic outcomes (mean difference: 0.148, 95% CI: -0.277-0.573, p = 0.494). CTG is more effective than AXDM in treating multiple gingival recessions. This is evidenced by significant reductions in gingival recession height and width, a higher mean percentage of root coverage, and a greater percentage of complete root coverage at the 6-month follow-up. In some clinical situations an alternative to CTG is required for the treatment of multiple gingival recessions. AXDM, despite presenting clinical outcomes that are not as satisfactory as CTG, can be used for this purpose.

Silica nanoparticles enhance interfacial self-adherence of a multi-layered extracellular matrix scaffold for vascular tissue regeneration.

Based on the clinical need for grafts for vascular tissue regeneration, our group developed a customizable scaffold derived from the human amniotic membrane. Our approach consists of rolling the decellularized amniotic membrane around a mandrel to form a multilayered tubular scaffold with tunable diameter and wall thickness. Herein, we aimed to investigate if silica nanoparticles (SiNP) could enhance the adhesion of the amnion layers within these rolled grafts. To test this, we assessed the structural integrity and mechanical properties of SiNP-treated scaffolds. Mechanical tests were repeated after six months to evaluate adhesion stability in aqueous environments. Our results showed that the rolled SiNP-treated scaffolds maintained their tubular shape upon hydration, while non-treated scaffolds collapsed. By scanning electron microscopy, SiNP-treated scaffolds presented more densely packed layers than untreated controls. Mechanical analysis showed that SiNP treatment increased the scaffold's tensile strength up to tenfold in relation to non-treated controls and changed the mechanism of failure from interfacial slipping to single-point fracture. The nanoparticles reinforced the scaffolds both at the interface between two distinct layers and within each layer of the extracellular matrix. Finally, SiNP-treated scaffolds significantly increased the suture pullout force in comparison to untreated controls. Our study demonstrated that SiNP prevents the unraveling of a multilayered extracellular matrix graft while improving the scaffolds' overall mechanical properties. In addition to the generation of a robust biomaterial for vascular tissue regeneration, this novel layering technology is a promising strategy for a number of bioengineering applications.

A Novel Prehydrated Porcine-Derived Acellular Dermal Matrix: A Histological and Clinical Evaluation.

It is well known that soft tissue quality and quantity around dental implants is of paramount importance for later peri-implant health. For this purpose, the clinical and histological outcomes of the peri-implant mucosa, following soft tissue augmentation for soft tissue improvement with a novel prehydrated porcine acellular dermal matrix graft (PPADMG) in conjunction with simultaneous implant placement, were evaluated in this case series. Twenty-two patients were included in the study. They underwent a late implant placement protocol combined with PPADMG for soft tissue augmentation. A punch biopsy was taken at the time of uncovery of the submerged healed implant after a mean of 157 days healing time. Supracrestal soft tissue height (STH) was measured at the time of implant placement and uncovery. All sites showed a clinical increase in STH. The histological structure of the biopsies resembled a similar structure as found in the healthy oral mucosa. No unexpected tissue reactions could be found. Within the limits of this clinical and histological study, it may be concluded that STH improvement with this novel porcine-derived acellular dermal matrix, in combination with simultaneous implant placement, is a viable option to create a peri-implant tissue thickness and stability.

Subcutaneously Engineered Decalcified Bone Matrix Xenografts Promote Bone Repair by Regulating the Immune Microenvironment, Prevascularization, and Stem Cell Homing.

Immunoregulatory and vascularized microenvironments play an important role in bone regeneration; however, the precise regulation for vascularization and inflammatory reactions remains elusive during bone repair. In this study, by means of subcutaneous preimplantation, we successfully constructed demineralized bone matrix (DBM) grafts with immunoregulatory and vascularized microenvironments. According to the current results, at the early time points (days 1 and 3), subcutaneously implanted DBM grafts recruited a large number of pro-inflammatory M1 macrophages with positive expression of CD68 and iNOS, while at the later time points (days 7 and 14), these inflammatory cells gradually subsided, accompanying increased presence of anti-inflammatory M2 macrophages with positive expression of CD206 and Arg-1, indicating a gradually enhanced anti-inflammatory microenvironment. At the same time, the gradually increased angiogenesis was observed in the DBM grafts with implantation time. In addition, the positive cells of CD105, CD73, and CD90 were observed in the inner region of the DBM grafts, implying the homing of mesenchymal stem cells. The repair results of cranial bone defects in a rat model further confirmed that the subcutaneous DBM xenografts at 7 days significantly improved bone regeneration. In summary, we developed a simple and novel strategy for bone regeneration mediated by anti-inflammatory microenvironment, prevascularization, and endogenous stem cell homing.

Viability of Collagen Matrix Grafts Associated with Nanohydroxyapatite and Elastin in Bone Repair in the Experimental Condition of Ovariectomy.

Bone lesions have the capacity for regeneration under normal conditions of the bone metabolism process. However, due to the increasing incidence of major traumas and diseases that cause bone-mineral deficiency, such as osteoporosis, scaffolds are needed that can assist in the bone regeneration process. Currently, natural polymeric scaffolds and bioactive nanoparticles stand out. Therefore, the objective of the study was to evaluate the osteoregenerative potential in tibiae of healthy and ovariectomized rats using mineralized collagen and nanohydroxyapatite (nHA) scaffolds associated with elastin. The in-vivo experimental study was performed with 60 20-week-old Wistar rats, distributed into non-ovariectomized (NO) and ovariectomized (O) groups, as follows: Controls (G1-NO-C and G4-O-C); Collagen with nHA scaffold (G2-NO-MSH and G5-O-MSH); and Collagen with nHA and elastin scaffold (G3-NO-MSHC and G6-O-MSHC). The animals were euthanized 6 weeks after surgery and the samples were analyzed by macroscopy, radiology, and histomorphometry. ANOVA and Tukey tests were performed with a 95% CI and a significance index of p < 0.05. In the histological analyses, it was possible to observe new bone formed with an organized and compact morphology that was rich in osteocytes and with maturity characteristics. This is compatible with osteoconductivity in both matrices (MSH and MSHC) in rats with normal conditions of bone metabolism and with gonadal deficiency. Furthermore, they demonstrated superior osteogenic potential when compared to control groups. There was no significant difference in the rate of new bone formation between the scaffolds. Ovariectomy did not exacerbate the immune response but negatively influenced the bone-defect repair process.

Histological examination of tooth-derived biomaterials obtained from different devices

ABSTRACT Aim The aim of the present study was to investigate the histological differences between samples processed by different devices and to confirm safe clinical application of different dentin matrix obtained from three devices: BonMaker, Tooth Transformer, and Smart Dentin Grinder in regeneration of maxillary defects. Research design The study involved 39 patients with two-wall or three-wall defects who underwent bone augmentation procedures in the maxilla using dentin matrix grafts from the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices. Histological examination was conducted on samples obtained from patients who received each device. In this article, histological samples have been selected and are presented. Results In all patients, bone defects were successfully augmented with ground dentin matrix. The histological examination revealed no inflammation and a good connection between the bone and dentin matrix and clinically all patients were qualified for implant placement. Conclusions After comparing the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices in our practice, we concluded that all these systems have the potential for obtaining regenerative material from the patient’s teeth.

Successful Use of Acellular Small Intestinal Submucosa Graft in Vaginal Reconstruction

PurposeVarious techniques for neovaginal construction have been employed in the pediatric and adult populations, including the use of intestinal segments, buccal mucosal grafts, and skin grafts. Small intestinal submucosa (SIS) extracellular matrix grafts have been described as a viable alternative, though prior experience is limited. Our purpose was to assess operative characteristics and patient outcomes with neovaginal construction using SIS grafts. MethodsThirteen patients underwent vaginoplasty with acellular porcine SIS grafts at our institution between 2018 and 2022. Operative and clinical data, postoperative mold management, vaginal dilating length, and complications were reviewed. ResultsAge at time of repair ranged from 13 to 30 years (median 19 years). Patient diagnosis included cloacal anomalies (n = 4), Mayer-Rokitansky-Küster-Hauser syndrome (n = 4), isolated vaginal atresia with or without a transverse vaginal septum (n = 4), and vaginal rhabdomyosarcoma requiring partial vaginectomy (n = 1). Following dissection of the neovaginal space, a silicon mold wrapped with SIS graft was placed with retention sutures and removed on postoperative day 7. Median (IQR) operative time was 171 (118–192) minutes, estimated blood loss was 10 (5–20) mL, and length of stay was 2 (1–3) days. The follow-up period ranged from 3 to 47 months (median 9 months). Two patients developed postoperative vaginal stenosis that resolved with dilation under anesthesia. Mean vaginal length on latest follow-up was 8.97 cm. All thirteen patients had successful engraftment and progressed to performing self-dilations or initiating intercourse to maintain patency. There were no cases of graft reaction or graft extrusion. ConclusionsWe conclude that acellular small intestinal submucosa grafts are effective and safe alternatives for mold coverage in neovaginal construction. Our experience demonstrates minimal perioperative morbidity, early mold removal, and progression to successful dilation with maintenance of a functional vaginal length. Future study on sexual outcomes, patient satisfaction, and comparison against alternative techniques has been initiated. Level of EvidenceIV. Type of StudyRetrospective Study.

Quality by Design: Development of Safe and Efficacious Full-Thickness Acellular Dermal Matrix Based on EuroGTPII Methodologies.

The activities of tissue establishments are constantly and rapidly evolving. The development of a new type of allograft, full-thickness acellular dermal matrix, with high mechanical properties to be used in tendon repair surgeries and abdominal wall reconstruction, has determined the need for quality by design process in order to assess evidence of quality, safety and efficacy. The EuroGTPII methodologies were specifically tailored to perform the risk assessment, identify and suggest tests in order to mitigate the potential risk consequences of a novel tissue preparation implementation. The new allograft and associated preparation processes were assessed using the EuroGTP methodologies and characterized to properly evaluate the novelty (Step 1), identify and quantify the potential risks and risk consequences (Step 2), and define the extent of pre-clinical and clinical assessments required to mitigate the risks identified in the assessment (Step 3). Four risk consequences associated with the preparation process were identified: (i) implant failure related with tissue procurement and the reagents used during the decellularization protocol; (ii) unwanted immunogenicity related with the processing; (iii) disease transmission linked with the processing, reagents used, reduction in the reliability of microbiology testing and the storage conditions; and (iv) toxicity related to the reagents used and handling of the tissue during clinical application. The outcome of the risk assessment was a low level of risk. Nevertheless, it determined the need for a series of risk mitigation strategies proposed to reduce each individual risk and to provide additional evidence of the safety and efficacy of full-thickness acellular dermal matrix grafts. EuroGTPII methodologies allow us to identify the risks and ensure the correct definition of pre-clinical assessments required to address and mitigate the potential risk consequences, before proceeding with clinical use of the new allografts in patients.