Bone Density Loss (Osteoporosis/Osteopenia)

Researchers are investigating the effectiveness of the "Pontic-shield" technique in preserving the alveolar ridge after tooth extraction. This study compares this technique with two other approaches: ridge preservation using deproteinized bovine bone and a porcine collagen membrane, and no intervention after extraction (fresh socket). The trial aims to understand which method better maintains bone structure, addressing challenges in long-term dental implant success. The study is a three-arm randomized clinical trial. Participants are assigned to one of three groups: the experimental group receiving the "Pontic-shield" technique, where a 1mm thick fragment of the tooth root is left in place; the positive control group receiving ridge preservation with bovine bone and collagen membrane; and the negative control group receiving no insertion after extraction, allowing the blood clot to form naturally. A cone-beam computed tomography scan is done before extraction and again four months after to evaluate bone changes. Participants will undergo tooth extraction and assigned treatment. Their bone resorption is measured from extraction day to four months after. Satisfaction is also assessed using a visual analogue scale during the first week post-surgery. The study includes adults aged 18 to 80 who require extraction of specific teeth and agree to participate. Safety and healing are monitored throughout. Total follow-up lasts at least four months after extraction to assess outcomes.

Researchers are studying the usefulness of 3D-printed tooth replicas combined with autotransplantation of teeth in children and young adults who need tooth transplantation. This study is designed to compare the 3D generated tooth replicas with the conventional methods to see if the new technology improves the surgical process and success of tooth transplantation. The study is led by Turku University Hospital and includes participants aged 9 to 23 years. Participants will undergo tooth autotransplantation surgery using either a 3D-printed tooth replica or a conventional procedure. Researchers will evaluate factors such as the duration of surgery and the degree of manipulation needed during the transplant procedure. They will also assess how well the transplanted tooth erupts and develops its roots over time. Participants will be followed for one year after surgery. During this time, clinical and radiological examinations will be performed to determine the health of the transplanted teeth. The main outcomes measured include the number of patients with healthy transplanted teeth at one year. This monitoring will help researchers understand the effectiveness of using 3D replicas in tooth autotransplantation.

Researchers are comparing the survival rates of different ceramic dental implants in adults with missing or hopeless teeth. This observational study focuses on two types of CeraRoot ceramic implants: one-piece and two-piece (TL) models. The study aims to determine if there are significant differences in implant survival and to identify any complications associated with the procedures in these groups. The study involves patients from two dental centers in Barcelona, Spain, and Boulder, Colorado, USA. Participants will receive either one-piece or two-piece CeraRoot ceramic dental implants. These implants are specially designed for patients with metal allergies or chronic illnesses related to metal allergies. The study will follow patients for at least 12 months after enrollment to monitor implant survival and complications. During the study, researchers will collect information on implant survival rates and any complications occurring within one year after treatment. Participants will undergo dental assessments to evaluate implant status and oral health. The study's main outcome is the survival rate of the implants over 12 months or longer. This long-term follow-up helps understand the performance and safety of these ceramic dental implants in real-world clinical settings.

Researchers are evaluating the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants in patients who have experienced tooth loss. This observational prospective cohort study aims to determine if these drilling-free implants are safe, effective, and clinically viable over a 36-month period and whether they provide better post-operative outcomes compared to traditional implant methods. The study is conducted by the University of Sao Paulo. Participants in this study have received personalized dental implants using the iDENTICAL Dental Implant System immediately after tooth extraction during a previous interventional phase. This study follows a single group of twelve patients over 36 months, monitoring the implants at 12, 24, and 36 months after prosthesis installation. The focus is on assessing implant survival, peri-implant tissue health, post-operative comfort, bone preservation, and tissue integration. During the study, participants will undergo clinical and radiographic examinations at the specified time points to measure radiographic success, changes in peri-implant soft tissues, prosthetic outcomes, and other peri-implant clinical parameters. The study requires availability for follow-up visits throughout the 36-month observation period. Safety and efficacy data will be collected to understand the long-term outcomes of these customized dental implants.

Researchers are conducting a prospective, observational, multicenter study to evaluate the TSX dental implant system in patients needing implants in the upper jaw (maxilla) or lower jaw (mandible). The study aims to assess the safety, effectiveness, and clinical performance of these implants, with a focus on implant integration success and bone level changes over two years. Patients with prior failed implants, major bone grafting needs, or implant revisions are not eligible for this study. Participants will receive TSX dental implants and will have either a temporary prosthesis placed immediately or within 48 hours, or a temporary or final prosthesis placed between 3 to 16 weeks after implant surgery. The final restoration will occur no later than four months after implant placement, using the full range of ZimVie prosthetic systems. The study plans to enroll approximately 60 patients, with a total of 62 implants placed across all sites. During the study, patients will return for yearly follow-up visits over two years to evaluate implant integration success and implant survival. Researchers will measure primary stability during placement and monitor changes in bone levels around the implants at various visits. Participants must agree to be evaluated at each study visit and provide informed consent. The total duration of follow-up is two years after implant placement surgery.

This research aims to evaluate the safety and early effects of vitamin K2 (menaquinone-7, MK-7) supplementation in adults aged 40 to 75 years with low bone mineral density, including osteopenia or osteoporosis. The study focuses on individuals carrying a specific "unfavorable" variant in the vitamin D receptor (VDR) gene, comparing them to those without this gene variant. The goal is to see if MK-7 supplementation improves bone health and related markers more in the variant group, who may have a reduced response to vitamin D. Participants will receive vitamin K2 (menaquinone-7) at doses of 100 to 200 micrograms per day along with vitamin D3 at 800 to 1000 IU per day for a period of 6 to 9 months. The study has two groups: one with homozygous carriers of the VDR variant and one control group without the variant. Both groups will follow the same supplementation regimen to compare outcomes related to bone health. During the study, participants will be monitored for changes in bone mineral density over 9 months, along with serum osteocalcin levels, bone turnover markers, vitamin D levels, and quality of life measures. Safety and tolerability will be assessed by recording any treatment-related adverse events. Participants will maintain stable diets and exercise routines, and genotyping will confirm their group assignment. Total participation will last up to 9 months with regular assessments.

Researchers are conducting a monocentric observational prospective study to assess how common vertebral fractures are among male patients aged 50 years and older who undergo chest-abdomen CT scans for reasons other than bone metabolic diseases. The study aims to use advanced imaging techniques combined with artificial intelligence to identify fractures that may otherwise be unnoticed. Participants will have their CT scans evaluated both by radiologists using automatic 3D reconstruction of the thoracic and lumbar spine and by AI software called NanoxAIHealthVCF from NANO-X IMAGING LTD. The study plans to enroll about 250 patients between March 1, 2025, and February 28, 2026. If one or more vertebral fractures are detected by either method, the patient will be referred for further evaluation in an Endocrinology Unit as part of standard care. Participants will provide clinical, body measurement, and medical history data at the time of their CT scan. The study involves only one evaluation during the CT scan visit, with no additional study visits unless a fracture is found. The main outcome measured is the number of vertebral fractures detected by the combined AI and 3D reconstruction method during the specified enrollment period. The study is observational, so no experimental treatment is given, and patient care follows usual medical practices.

Researchers are evaluating the performance of an artificial intelligence software called Osteo Signal in detecting the risk of osteoporosis in adults aged 50 years and older. The study aims to determine how accurately the software can identify osteoporosis risk using chest x-ray images compared to the standard method of dual-energy x-ray absorptiometry (DXA). This observational study uses past imaging data collected from individuals who have previously undergone both chest x-rays and DXA scans. The main intervention being assessed is the Osteo Signal AI software, which analyzes chest x-rays to screen for osteoporosis risk. There are no new treatments or procedures for participants since the study is retrospective and uses existing imaging data collected within six months of each other. The study involves comparing the AI software's results against the DXA scan findings to classify bone status. Participants are not directly involved as the study uses existing medical images and records, including chest x-rays and DXA scans performed after January 2010. Researchers will analyze these images along with metadata such as age and sex. The primary outcome is the accuracy of classifying bone status as osteoporosis or non-osteoporosis. Secondary outcomes include more detailed classifications such as osteopenia and normal bone status. The study is designed to monitor the software's performance without requiring additional visits or interventions from participants.

Researchers are evaluating the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, comparing results with those from the FREEDOM substudy. This study focuses on women aged 60 to 90 years who have a BMD T-score between -4.0 and -2.5. It aims to assess ACC's impact both with and without the addition of Denosumab treatment, an osteoporosis therapy, in an open-label setting. Participants are assigned to one of two groups: the A arm includes women who meet National Health Insurance (NHI) criteria for Denosumab and receive 5 ACC tablets daily plus a 60 mg Denosumab injection every 6 months; the B arm includes women who do not meet NHI criteria or prefer not to receive Denosumab and take 5 ACC tablets daily only. All participants with certain vitamin D levels receive daily vitamin D3 supplements. The study spans 7 clinic visits over 24 months, including screening, treatment start, and follow-up visits. During visits, researchers perform BMD assessments and blood draws at baseline and months 1, 6, 12, and 24. They monitor changes in lumbar spine BMD as the primary outcome, along with overall BMD and bone turnover markers over 2 years. Participants are expected to comply with vitamin D intake limits and complete study procedures, allowing researchers to evaluate the effects of ACC with or without Denosumab on bone health.

Researchers are evaluating the clinical efficacy, safety, and immune response of the drug 9MW0311 compared to Prolia® in Chinese postmenopausal women with osteoporosis who are at high risk for fractures. This Phase III, multicenter, randomized, double-blind study aims to better understand how these treatments affect bone density over a year. The study focuses on women aged 50 to 80 years with osteoporosis and additional risk factors for fractures. Participants are randomly assigned to one of two groups to receive either 9MW0311 or Prolia®, both given as a 60 mg denosumab injection under the skin every six months for a total of two doses over 12 months. The main goal is to measure the percentage change in bone mineral density (BMD) of the lumbar spine after one year. Secondary measures include changes in BMD at other bone sites, bone turnover markers, fracture occurrence, and assessment of any side effects or immune reactions. Throughout the study, participants will undergo bone density scans, blood tests for bone markers and immune response, and monitoring for fractures and adverse events at various time points up to 12 months. Safety assessments include vital signs, physical and oral exams, lab tests, and heart monitoring. The study tracks participants' health and treatment effects carefully to evaluate both drugs' performance and tolerability over the course of the year.