Tissue Engineering

Researchers are studying craniofacial deformities, which affect facial appearance and oral function, to better understand the results of autologous fat grafting, a common treatment for facial concave deformities. The study focuses on measuring how much transplanted fat remains over time, as the absorption rate of fat varies widely and affects treatment outcomes. This observational trial uses advanced 3D facial scanning technology to improve the accuracy of these measurements and explore individual factors influencing fat graft survival. Participants will undergo autologous fat grafting surgery, and their facial volume will be measured using the 3dMD face system before surgery, immediately after, and six months later. This technology captures precise three-dimensional facial images and calculates volume changes to determine fat retention rates. The study will analyze data from 100 patients to assess fat absorption and investigate how factors like age, physical health, and surgical technique affect results. During the study, participants will have 3D facial scans at three key timepoints before surgery, immediately post-surgery, and six months after. Researchers will analyze these scans to calculate the fat retention rate and assess patient satisfaction at four weeks and one year after surgery. The study aims to provide detailed, objective data to improve understanding of fat grafting outcomes and support better treatment strategies for craniofacial deformities.

This research aims to evaluate the effectiveness of using a 3D scan to create personalized ostomy appliances for people with an ostomy. The study focuses on whether a 3D scan of the stoma can reduce leakages and improve quality of life compared to standard care. Ostomy appliances collect waste from the stoma but often cause complications such as skin irritation, leaks, and infections, which impact patients daily lives. Participants will have their stoma scanned with a 3D scanner to create a detailed digital model. This model is then edited and used to produce a personalized ostomy appliance by modifying standard appliances with a laser cutter. The study involves two 2-week periods where participants use their usual ostomy appliance first, then the personalized 3D-printed appliance. The personalized appliances are designed with input from an ostomy nursing team to ensure proper fit based on each patients body and stoma. During the 4-week study, participants will complete daily symptom diaries and weekly quality of life surveys conducted over the phone. Researchers will track leak incidents, the number of appliances used, and overall patient satisfaction. The study includes ongoing monitoring through electronic surveys requiring internet and device access. Total participation lasts about one month, with safety and quality of life as key measures.

This clinical trial focuses on evaluating how different 3D printing angles and layer thicknesses affect the fit, accuracy, and patient satisfaction of maxillary complete dentures in patients who have lost all their upper teeth. The study involves adults aged 50 to 70 with complete edentulism who require new maxillary and mandibular dentures. Researchers aim to identify the best 3D printing settings for making these dentures by comparing three build orientations 0, 45, and 90. Participants will receive two maxillary dentures made using the same printing orientation but with two different layer thicknesses 50 micrometers and 100 micrometers in a crossover design. Each denture will be worn for three months before switching to the other. The study groups are based on the printing angle used 0, 45, or 90. The accuracy of the dentures is measured by scanning and comparing the printed dentures to the original digital designs. During the study, participants will be assessed on how true to the design the dentures are, how much the dentures change dimensionally over three months, and their satisfaction based on comfort, speech, chewing efficiency, hygiene, and appearance. Satisfaction is measured using a Visual Analogue Scale shortly after insertion and again after three months of use. The study will last about six months per participant, covering both denture wear periods.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

Researchers are evaluating the safety profile of OviTex PRS, a reinforced tissue matrix device, in patients who have previously undergone implant-based breast reconstruction. This observational study includes both retrospective and prospective data and focuses on women aged 18 to 75 years who received either pre-pectoral or sub-pectoral breast implants using OviTex PRS. The study aims to understand overall safety and device-specific safety to help guide future studies on effectiveness. The study involves patients who had immediate or two-stage unilateral or bilateral implant-based breast reconstruction using OviTex PRS devices, either permanent or resorbable. The reconstruction could have been performed in the sub-pectoral or pre-pectoral position. This multi-center study includes patients who have completed their initial and, if applicable, exchange surgeries. Some participants may also take part in a prospective portion that includes returning for in-person visits and photograph completion. Participants will be followed for safety outcomes up to 24 months after OviTex PRS implantation. Researchers will collect data on the occurrence of relevant adverse events, time to expander or implant exchange, intraoperative fill volumes and visits, and aesthetic assessments using the Telemark Breast Score and Rainbow Scale. Hospitalization length of stay at the time of procedure will also be recorded. The study monitors participant adherence and safety throughout this period, providing important insights into the devices use in breast reconstruction.

Researchers are evaluating the use of an acellular collagen matrix to improve wound healing after guided bone regeneration GBR procedures in patients who need increased bone volume in the jaw before dental implant placement. This study compares healing outcomes between patients whose wound is closed with the acellular matrix versus those who receive traditional surgical closure without it. The study focuses on early wound healing and aims to assess whether the acellular matrix helps prevent shallow vestibulum formation and reduces the need for additional surgeries. During the GBR procedure, bone grafting material is placed in the jawbone defect and covered with a barrier membrane. When the membrane is exposed due to limited tissue coverage, the acellular matrix may be placed over it to aid healing. Patients receive either the acellular matrix covering or standard surgical closure without the matrix, based on their dental surgeons judgment. Standard postoperative care including antibiotics, pain control, and antiseptic mouthwash is provided. The study collects additional clinical and radiographic measurements before and after surgery, along with patient-reported experience data. Participants will have follow-up visits at 8-10 days, 6-8 weeks, and 4-6 months after surgery, during which wound healing will be assessed through clinical exams, CBCT scans, and implant stability checks. The study will measure healing scores and ridge dimension changes over time. Each visit may last about 40 minutes longer than routine appointments due to research-related assessments. The total observation period lasts up to 4-6 months, ending around the time of implant placement surgery.

Researchers are studying the best cementation methods and resin cement materials to improve the long-term success of aesthetic dental restorations, specifically porcelain veneers and direct composite restorations for front teeth. The study aims to compare two types of resin cements, Panavia Veneer LC and universal Panavia V5, in terms of marginal defects and discoloration. It will also evaluate patient satisfaction using the Orofacial Esthetic Scale OES after 1-year and 3-year follow-up periods. Participants will receive either porcelain veneers or direct composite restorations as aesthetic treatments. Porcelain veneers involve preparing the front upper teeth with a 0.5mm deep facial surface reduction and cementing laboratory-made veneers using two different cements for comparison. Digital impressions will be taken with an intraoral scanner, and veneers will be fabricated using CADCAM technology. Direct composite restorations will be created with digital modeling and injectable composite materials. Each patient will have two veneers cemented with each type of cement to allow direct comparison. During the study, researchers will monitor restoration condition, including ceramic fractures, cracks, retention loss, and discoloration. They will also assess the health of supporting teeth, checking for secondary caries or endodontic issues, as well as periodontal health through probing and gum evaluation. Patient satisfaction will be measured through questionnaires. Follow-ups will occur at 6 months, 1 year, and 3 years to observe outcomes and any complications. The total participation time varies according to these follow-ups.

Researchers are monitoring the effectiveness and safety of Autologous Fat Transfer AFT with pre-expansion as a method for full breast reconstruction in female breast cancer patients. This multicenter, prospective cohort study follows the BREAST trial and aims to evaluate quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. All participants will receive AFT in this observational study. Participants will undergo breast reconstruction using Autologous Fat Transfer combined with an external expansion device. This procedure is offered to women who have had or will have a mastectomy, including preventive mastectomy. The study focuses on assessing various outcomes over several years, with particular attention to quality of life and aesthetic results at two years, and oncological safety up to five years after treatment. During the study, participants will be monitored for breast-related quality of life, aesthetic results, any complications, oncological safety, and the cost-effectiveness of the procedure. These outcomes will be assessed through regular follow-ups and evaluations over a period of two to five years. The study is led by Maastricht University Medical Center and aims to provide comprehensive information on this breast reconstruction method.

Researchers are studying autologous epidermal cell transplantation to help repair large, deep wounds caused by severe burns. This approach addresses the challenge of limited normal skin available for grafting in patients with extensive burns. Traditional skin grafting methods require multiple procedures and have limited expansion, leading to longer healing times and increased scarring. This research evaluates a new technique that expands a small piece of a patients own skin cells in the lab to create larger grafts for wound repair, aiming to improve healing and reduce complications. The treatment involves taking small pieces of the patients skin and rapidly growing the epidermal cells in the lab by 1000 to 5000 times over 2 to 3 weeks. These cultured epidermal cell membranes are then combined with expanded or allogeneic dermis grafts to cover large wounds. This method aims to shorten the time for graft integration, increase survival of the grafts, and reduce scarring. It offers a potential solution for patients with limited skin available for traditional grafts, especially those with very large and deep burns. Participants will be patients with wounds covering 30% or more of their body surface area that require at least two weeks to heal. Researchers will evaluate the success of the grafts by measuring the take rate of the cultured epidermal autografts after 4 weeks and monitor for any serious adverse events up to 52 weeks after treatment. The study involves careful monitoring of wound healing, safety, and long-term outcomes to assess this innovative skin repair method. Total participation duration and follow-up details are based on these outcome timelines.

Researchers are studying patients who have undergone reconstructive surgery on their upper or lower limbs using an anterolateral thigh flap. The study aims to monitor these patients after surgery to better detect flap failure, a complication caused by blood flow problems. This observational pilot study focuses on combining traditional clinical assessments with continuous tissue oxygenation measurements using a near-infrared spectroscopy NIRS device called FORE-SIGHT ELITE. The goal is to find preliminary data on tissue oxygenation cut-off values that may indicate flap failure. During the study, patients will be monitored using the current gold standard methods, which include checking the flaps skin color, temperature, tissue turgor, capillary refill time, and Doppler techniques. Alongside these, continuous tissue oxygenation will be measured with the FORE-SIGHT ELITE device, with sensors placed at both the flap and donor sites after surgery. These oxygenation readings will be blinded to patients and nursing staff during the five-day monitoring period. Patients will stay overnight in the Post Anesthetic Care Unit PACU and then transfer to a regular ward, where clinical checks will continue. Participants clinical assessments will be performed hourly during the first 24 hours and regularly thereafter, including vital signs monitoring. Nurses will notify surgeons if clinical signs suggest flap problems. After five days, researchers will analyze the stored NIRS data comparing patients with flap failure to those without. The study will also perform a retrospective time-to-event analysis in patients with flap failure over about one year to better understand tissue oxygenation trends. This monitoring aims to improve early detection of flap failure and guide timely treatment.