Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Alveolar Bone Augmentation Using Mesenchymal Stem Cells and Biphasic Calcium Phosphate for Patients with Jaw Bone Defects

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on helping patients with jaw bone defects, specifically those with less than 4 mm in width. The study aims to explore a new treatment method using mesenchymal stem cells, which are special cells that can develop into different types of tissues, and biphasic calcium phosphate granules, a material that supports bone growth. These stem cells, also known by the code name ImmuStem, are injected into the affected area to help regenerate bone, making it possible to place dental implants successfully.

The purpose of the study is to assess the safety and effectiveness of this treatment approach. Participants will receive an injection of these stem cells directly into the area where bone growth is needed. The study will monitor changes in bone width and the ability to place dental implants six months after the procedure. Throughout the study, participants will be observed for any side effects and the healing process of the soft tissues will be evaluated.

Participants' experiences and satisfaction with the treatment will also be assessed through questionnaires. The study will track the fate of the transplanted stem cells and evaluate the bone's response to the treatment. The overall goal is to improve the quality of life for patients needing dental implants by providing a reliable method to increase bone width in the jaw.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written informed consent, confirming understanding and agreement to participate.

    Eligibility includes being 18 years or older, having insufficient bone ridge width or height for implant placement, and having healthy oral mucosa.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to measure the bone width using CBCT images. This serves as a baseline for future comparisons.

  3. Step 3

    Bone augmentation procedure

    The patient undergoes a bone augmentation procedure using mesenchymal stem cells and biphasic calcium phosphate granules.

    The procedure involves the transplantation of these cells through an injection into the affected area.

  4. Step 4

    Post-procedure monitoring

    The patient is monitored for adverse effects and soft tissue healing at 2 weeks, 4 weeks, and 6 months post-procedure.

    Monitoring includes checking for signs of infection, swelling, and other healing-related issues.

  5. Step 5

    Follow-up assessments

    Six months after the bone augmentation, a follow-up assessment is conducted to measure changes in bone width and evaluate the ability to place implants.

    The patient's satisfaction and quality of life are assessed using structured questionnaires.

  6. Step 6

    Implant placement

    If the bone has regenerated adequately, dental implants are placed in the reconstructed area.

    The stability of the implants is evaluated at the time of installation and at subsequent stages.

  7. Step 7

    Final evaluation

    A final evaluation is conducted 12 months after loading the implants to assess implant stability and overall success of the procedure.

    The need for any additional bone augmentation is also evaluated.

Who can join the trial?

8 criteria

  • Provide written informed consent, which means you agree to participate after understanding the study details.
  • Be able to understand and complete the informed consent process.
  • Be 18 years or older.
  • Have a bone ridge width of 4 mm or less, which means the bone in your jaw is too narrow for an implant.
  • Have healthy oral mucosa, which is the lining inside your mouth, with at least 2 mm of keratinized mucosa, a type of firm tissue.
  • If you are a woman who can have children, you must have a pregnancy test before joining the study to ensure you are not pregnant.
  • If the pregnancy test is negative, you must use contraceptives until the dental implants are placed, which is about 6 months after the bone procedure.
  • If you are a woman who has been in menopause for less than 12 months, you need a test to confirm this by checking the level of a hormone called follicle stimulating hormone (FSH).

Who cannot join the trial?

12 criteria

  • Patients with a history of severe allergies or allergic reactions to the materials used in the study.
  • Individuals with uncontrolled diabetes, which means their blood sugar levels are not well managed.
  • Patients who are pregnant or breastfeeding.
  • People with active infections in the mouth or jaw area.
  • Individuals with a history of cancer in the jaw or mouth area.
  • Patients who have received radiation therapy in the head or neck region.
  • People with autoimmune diseases, which are conditions where the body's immune system attacks its own tissues.
  • Individuals taking medications that suppress the immune system, making it weaker.
  • Patients with blood clotting disorders, which affect how the blood clots and can lead to excessive bleeding.
  • People with severe heart or lung diseases that are not well controlled.
  • Individuals with psychiatric disorders that are not stable or well managed.
  • Patients who have participated in another clinical trial within the last 30 days.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Mesenchymal Stem Cells (MSCs)

    are special cells taken from your own body that have the ability to develop into different types of cells, including bone cells. In this trial, they are used to help regenerate bone in your jaw to prepare for dental implants.

  • Biphasic Calcium Phosphate Granules

    are small particles made from a combination of two types of calcium phosphate. These granules are used as a scaffold to support the growth of new bone tissue in your jaw, working together with the mesenchymal stem cells to help create a strong foundation for dental implants.

What is already known about the treatment

Mesenchymal Stem Cells (MSCs) – This treatment involves the use of autologous mesenchymal stem cells, which are administered directly to the site of bone defects in the jaw. The current status in medical literature is experimental, as it is being evaluated in clinical trials for its safety and effectiveness in bone regeneration. The main therapeutic indication is to augment alveolar bone in patients with insufficient bone width for dental implants. At the molecular level, MSCs promote bone growth by differentiating into bone-forming cells and releasing growth factors that stimulate tissue repair. This treatment falls under the pharmacological classification of regenerative medicine.

Investigated diseases

Alveolar Bone Defect – This condition involves a deficiency in the bone structure of the jaw, specifically when the lateral width of the alveolar bone is less than 4 mm. It can occur due to various reasons, such as tooth loss, trauma, or periodontal disease. The progression of this condition can lead to difficulties in placing dental implants due to insufficient bone support. Over time, the lack of adequate bone can affect the stability and function of dental prosthetics. Bone augmentation procedures are often considered to regenerate the bone and restore its width to support dental implants effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517976-39-00Estimated enrolment20 patientsSponsorUniversity of Bergen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.