Development and validation of cryopreserved or freeze-dried decellularized human dermis for transplantation.

For decades, dermal tissue grafts have been used in various regenerative, reconstructive, and augmentative procedures across the body. To eliminate antigenicity and immunogenic response while still preserving the individual components and collective structural integrity of the extracellular matrix (ECM), dermis can be decellularized. Acellular dermal matrix (ADM) products like such are produced to accurately serve diverse clinical purposes. The aim of the present study is to evaluate the efficacy of a novel decellularization protocol of the human dermis, which eliminates residual human genetic material without compromising the biomechanical integrity and collagenous content of the tissue. Moreover, a freeze-drying protocol was validated. The results showed that though our decellularization protocol, human dermis can be decellularized obtaining a biocompatible matrix. The procedure is completely realized in GMP aseptic condition, avoiding tissue terminal sterilization.

Human amniotic membrane: an improvement in the treatment of Medication-related osteonecrosis of the jaw (MRONJ)? A case-control study.

The aim of this article is to report the results obtained by the use of HAM in surgical wound healing and the reduction of relapse in patients affected by Medication-related osteonecrosis of the jaw (MRONJ).The study involved patients with the diagnosis of MRONJ, surgically treated between October 2016 and April 2019, in a case-control setting. Enrolled patients were randomly divided into 2 groups. One group will be treated with resective surgery and with the insertion of HAM patch (Group A), while the second group had been treated exclusively with resective surgery (Group B).The patients underwent MRONJ surgical treatment with the placement of amniotic membrane patches at the wound site. Data regarding the long-term complications/functions were evaluated at 3, 6, 12, and 24 months after surgery. Pain measurements were performed before the intervention (T0), 7(T1) and 30(T2) days after surgery. 49 patients were included in the study. 2 patients of GROUP A after 30 days since they were surgically treated showed persistent bone exposure. 5 patients of group B demonstrated a lack of healing of the surgical wound with the persistence of bone exposed to 30 days after surgery. Statistical analysis ruled out any difference in OUTCOME (relapse) between GROUP A and B (p = 0.23). However, the Fisher test highlighted a significant difference between the use of HAM and only surgical treatment in pain at rest (p = 0.032). The use of amniotic membrane implement the patient's quality of life and reduce pain perception. has a learning curve that is fast enough to justify its routine use.

Computer-assisted surgery with custom prostheses and human amniotic membrane in a patient with bilateral class IV TMJ reankylosis: a case report.

A gold-standard technique has yet to be found for the treatment of temporomandibular joint ankylosis (TMJa), particularly in patients with recurring ankylosis. A 58-year-old male patient, with a history of multiple TMJ surgeries and severe limitation of mouth opening (maximum interincisal distance [MID] was 10 mm). Computerised tomography (CT) imaging highlighted a bilateral type IV ankylosis. The surgical guides were manufactured using a 3D printing method after obtaining a proper design of the osteotomy lines. The positioning of the fossa and condyle components of the custom TMJ prosthesis was digitally performed. Osteotomies were carried out using surgical guides and TMJ prostheses were placed as per the virtual planning. A human amniotic mambrana is inserted between the two prosthetic components to avoid ranchylosis. The post-operative CT showed the correct positioning of the condylar prosthesis. MID after 10 days was 37 mm. Total joint reconstruction surgery using 3D virtual surgical planning may be an effective surgical option for achieving a precise surgical outcome and making use of a single-stage approach in cases of TMJa and the use of the amniotic membrane, thanks to its healing properties and reduction of pain perception, seems to improve the quality of the immediate post-operative period.

Bilaminar Technique with Coronally Advanced Flap and Cryopreserved Human Amniotic Membrane in the Treatment of Gingival Recessions.

Gingival recessions are usually treated with surgical therapies which involve the use of connective tissue autograft in order to thicken the gingival tissue. This has an important biological repercussion on patients since they will have surgical wounds in two different oral cavity sites. In this case report, we offer an alternative technique for the treatment of a Miller class I gingival recession. A 40-year-old female patient has been treated with a combination of bilaminar and coronally advance flap techniques to cover a Miller class I gingival recession with addition of cryopreserved human amniotic membrane. The human amniotic membrane has been employed to thicken the keratinized tissue. The human amniotic membrane in combination with bilaminar and coronally advance flap techniques has produced aesthetically and functionally satisfying results, covering completely the gingival recession and restoring the natural colour and thickness of the gingiva. Bilaminar technique with coronally advanced flap and cryopreserved human amniotic membrane is a valid alternative in treating Miller class I and II gingival recessions and reduce the biological morbidity of a double intervention.

Use of homologous bone for alveolar crest reconstruction in 483 patients with 5 years' outcomes post implantation.

PURPOSE: The purpose of this study was to evaluate the clinical course of bone reconstruction of the alveolar crest using homologous fresh-frozen bone harvested from deceased donors. METHODS: A retrospective survey was based on the Castelfranco Veneto Hospital database, in which 3264 clinical records with a primary or secondary diagnosis of alveolar atrophy were collected over a 10-year period. A random sample of 483 patients with at least 5 years' follow-up was included in the survey. Patients were contacted by telephone and administered a questionnaire with specific questions to build a significant sample. RESULTS: Of the patients, 449 (93% of the sample) had an uneventful follow-up after surgery and 93.2% received at least one implant, with a mean of 3.4 implants per patient. At the time of the survey, 93% of the patients were wearing a dental prosthesis, 86.9% had not lost any implants, and 6.7% had lost at least one implant, while 6.4% still had implants but presented some clinical problems. Finally, patients were asked to provide an index score (1-10 points) on the therapy as a whole, i.e., bone graft, implants, and prostheses. A score of insufficient (up to 5 points) was given by 5.3% of patients, of sufficient (6 to 7 points) by 6.1%, and of good/very good (over 7) by 88.6%. CONCLUSIONS: Homologous bone for alveolar crest reconstruction can be a valid alternative to autologous grafting if specific tissue limitations are considered when planning therapy. Creeping substitution is partial and slower than in autologous grafts, especially in cases where cortical bone is thick or volume graft is very large. The quality of soft tissue coverage and mucosa lining is also important, possibly due to slower tissue revascularization, so future implants should predictably be positioned primarily within the original host bone.

Amniotic Membrane In Palatal Epithelial-Connective Tissue Reconstruction.

Mucogingival surgery has the objective to obtain coverage of the recession, with a favorable long-term prognosis, but also to minimize postoperative problems and surgery-related risks. Human amniotic membrane is increasingly employed for periodontal tissue repair in order to promote epithelialization and to reduce pain and scar tissue formation. A 38-year-old female patient reports dental hypersensitivity resulting from gingival recession affecting tooth 4.1. A mucogingival surgical procedure was proposed and a partial-thickness flap of epithelial-connective tissue was harvested from the palate and grafted on to the receiving site. The amniotic membrane was positioned at the donor site to reduce postoperative morbidity and to encourage rapid palatal healing. One week after the application of HAM (human amniotic membrane), the wound was healed and 1 month after the donor site was completely re-epithelialized. The present case report suggests that in the surgical treatment of gingival recession with palatal epithelial-connective tissue graft, HAM promotes rapid epithelialization of the palatal donor site wound with a reduction in morbidity.

Human Amniotic Membrane Positioning in the Surgical Treatment of Temporomandibular Joint Degenerative Disorder.

BACKGROUND: Temporomandibular joint (TMJ) arthritis is a degenerative pathology that may cause pain and dysfunction. Nonsurgical therapy is the traditional treatment of TMJ diseases but if ineffective, TMJ surgery can be performed and may include arthroplasty with interposition of autograft. The encouraging results reported with the use of human amniotic membrane (HAM) in different surgical fields have highlighted its potential, but approaches providing the positioning of HAM within the intra-articular space of arthritic TMJs have never been investigated. CASE PRESENTATION: A 48-year-old woman was presented with limited mouth opening and pain with palpation at the left joint. A severe TMJ degeneration was diagnosed, and a surgical treatment was necessary. In the present case report, the authors describe the application of a cryopreserved HAM patch within the joint space as a disc-replacing film during major surgeries for discectomy and arthroplasty. Three months after the intervention, the patient reported an overall improvement in chewing efficiency as well as the absence of pain. CONCLUSIONS: According to the regenerative effects of HAM, the design of trials on the topic should be encouraged for its possible inclusion within the field of TMJ disease practice.

Fresh-frozen homologous bone in sinus lifting: histological and radiological analysis.

BACKGROUND: The aim of this study was to evaluate radiological and histological characteristics of fresh-frozen homologous bone as grafting material for maxillary sinus floor augmentation. Radiological, histological and clinical evaluations were made. METHODS: Twenty-three patients with a 2 mm to 6 mm alveolar ridge height in the posterior maxilla have been enrolled. Unilateral or bilateral sinus floor augmentations were performed with fresh frozen morcelized homologous bone. Together with implant placement, 7 months after surgery, a bone core was harvested for histological analysis. Radiological measurements were obtained by superimposition of CT scans carried out at the surgery time and six months later. A total of 93 implants were positioned. RESULTS: A mean (±SD) increase in mineralized tissue height of 10.74±2.82 mm was noticed by comparing the CT scans. Histological analysis revealed the presence of newly formed bone in the grafted sites. The follow up period after the prosthetic load ranged from 8 to 31 months. One implant failure occurred. CONCLUSIONS: Fresh frozen homologous bone seems to have a good healing pattern and to be a successful and steady grafting material for the treatment of maxillary ridge atrophy. It might be considered a valid alternative to autologous bone in sinus floor augmentation procedures.

Use of amniotic membrane in the treatment of patients with BRONJ: two case reports.

The use of bisphosphonates has led to a new disease, bisphosphonate-related osteonecrosis of the jaw (BRONJ). There is currently no effective treatment for this disease; the surgical approach is controversial. The widespread use of human amniotic membrane (HAM) in surgery and the results obtained have highlighted its many potential properties, including antimicrobial, anti-inflammatory, antifibrotic and antiapoptotic, as well as its capacity for encouraging epithelialisation and cell differentiation. These properties are believed to encourage the recovery of patients with BRONJ, facilitating the wound healing process after surgical debridement of the bone. We report our experience with the use of HAM: two patients treated with patches of HAM. The follow-up to date, which includes x-rays and clinical assessments, demonstrates good levels of epithelialisation and absence of infections and pain. To conclude, the use of HAM in patients with BRONJ seems to be a promising therapeutic alternative to current conventional treatments.

Management of temporomandibular joint degenerative disorders with human amniotic membrane: Hypothesis of action.

Approaches providing the positioning of human amniotic membrane (HAM) within the intra-articular space of arthritic TMJs have never been investigated. This contrasts with the increasing amount of evidence suggesting the potential positive effects of HAM on a number of surgical conditions, even included the interpositional arthroplasty for TMJ ankylosis. Thus, the possible usefulness of HAM to restore joint functions in severely damaged TMJs could be hypothesized. Based on these premises, the clinical research question "Is human amniotic membrane positioning effective to reduce symptoms and restore jaw function in patients with severe inflammatory-degenerative disorders of the temporomandibular joint?" has been addressed by performing a systematic review of the literature. Out of potential 11988 and 8883 citations in the PubMed and Scopus databases, respectively, only five were of possible interest for inclusion in the review, but none of them addressed specifically the clinical research question. Thus, the hypothetical background for usefulness was discussed. The benefits of HAM positioning in TMJs with severe inflammatory-degenerative disorders could be related with its anti-inflammatory and anti-microbial and analgesic properties as well as its low immunogenicity. Studies in which HAM is positioned within the joint space of patients with severe TMJ degeneration, either as a disc-replacing film during major surgeries for discectomy and arthroplasty or as an injectable solution that can be needle-inserted after an arthrocentesis procedure, should be designed to test the hypothesis.

Decellularized Cryopreserved Allografts as Off-the-Shelf Allogeneic Alternative for Heart Valve Replacement: In Vitro Assessment Before Clinical Translation.

Cryopreserved allogeneic conduits are the elective biocompatible choice among currently available substitutes for surgical replacement in end-stage valvulopathy. However, degeneration occurs in 15 years in adults or faster in children, due to recipient's immunological reactions to donor's antigens. Here, human aortic valves were decellularized by TRICOL, based on Triton X-100 and sodium cholate, and submitted to standard cryopreservation (TRICOL-human aortic valves (hAVs)). Tissue samples were analyzed to study the effects of the combined procedure on original valve architecture and donor's cell removal. Residual amounts of nucleic acids, pathological microorganisms, and detergents were also investigated. TRICOL-hAVs proved to be efficaciously decellularized with removal of donor's cell components and preservation of valve scaffolding. Trivial traces of detergents, no cytotoxicity, and abrogated bioburden were documented. TRICOL-hAVs may represent off-the-shelf alternatives for both aortic and pulmonary valve replacements in pediatric and grown-up with congenital heart disease patients.