Clinical Trials for Alveolar Bone Defect
There is currently 1 ongoing clinical trial investigating new treatment approaches for alveolar bone defect, a condition where the jaw bone is too narrow to support dental implants. This trial is exploring the use of mesenchymal stem cells combined with calcium phosphate materials to help regenerate bone tissue and enable successful implant placement.
Clinical trial locations
- Norway
- Spain
Study on Alveolar Bone Augmentation Using Mesenchymal Stem Cells and Biphasic Calcium Phosphate for Patients with Jaw Bone Defects
This trial is being conducted in Spain and Norway and focuses on a promising new approach to help patients with jaw bone defects who need dental implants but lack sufficient bone width. The study specifically targets individuals whose jaw bone is less than 4 mm wide, making it difficult or impossible to place dental implants without first rebuilding the bone.
Main goal and investigational treatment: The trial aims to evaluate the safety and effectiveness of using mesenchymal stem cells, special cells taken from your own body that can develop into bone tissue, combined with biphasic calcium phosphate granules, a supportive material that encourages bone growth. The stem cells, referred to by the code name ImmuStem, are injected directly into the affected area to stimulate bone regeneration. The calcium phosphate granules act as a scaffold, providing structure for the new bone to grow around. The ultimate goal is to increase the jaw bone width enough to successfully place dental implants and improve patients’ quality of life.
Who can participate: To be eligible for this study, you must be at least 18 years old and have a bone ridge width of 4 mm or less in your jaw. You need to have healthy oral tissues with at least 2 mm of firm tissue called keratinized mucosa. Before joining, you must provide written informed consent, showing that you understand the study and agree to participate. Women of childbearing age must have a negative pregnancy test before enrollment and agree to use contraception until the dental implants are placed, approximately six months after the bone augmentation procedure. Women who have been in menopause for less than 12 months will need a hormone test to confirm their menopausal status.
Who cannot participate: The study excludes several groups of patients for safety reasons. You cannot join if you have a history of severe allergies to the materials used in the study, uncontrolled diabetes, or if you are pregnant or breastfeeding. Active infections in the mouth or jaw area, a history of cancer in the jaw or mouth, or previous radiation therapy to the head or neck region will also exclude you from participation. Additionally, people with autoimmune diseases, those taking medications that weaken the immune system, blood clotting disorders, severe uncontrolled heart or lung diseases, or unstable psychiatric conditions cannot participate. If you have taken part in another clinical trial within the last 30 days, you are also not eligible.
What the study involves: Participants will undergo a bone augmentation procedure where the mesenchymal stem cells and calcium phosphate granules are transplanted into the area needing bone growth. After the procedure, you will be monitored regularly at 2 weeks, 4 weeks, and 6 months to check for any side effects, signs of infection, swelling, and to assess how well the soft tissues are healing. Six months after the bone augmentation, the research team will measure changes in bone width and evaluate whether the area is ready for dental implant placement. If the bone has regenerated adequately, dental implants will be placed, and their stability will be assessed. A final evaluation takes place 12 months after the implants are loaded to determine the overall success of the procedure. Throughout the study, participants will also complete questionnaires about their satisfaction and quality of life.
Summary
Currently, there is only one clinical trial available for patients with alveolar bone defects, offering an innovative regenerative medicine approach. This trial is being conducted in two European countries, Spain and Norway, making it accessible to patients in these regions. The study focuses on using autologous mesenchymal stem cells combined with biphasic calcium phosphate granules to regenerate jaw bone tissue, addressing a significant clinical need for patients who require dental implants but lack sufficient bone support. The experimental nature of this treatment represents a cutting-edge approach in bone regeneration, though it is still being evaluated for safety and effectiveness. Patients interested in participating should consult with their healthcare providers to determine if they meet the eligibility criteria and to discuss the potential benefits and risks involved.
