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

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What is this study about?

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.

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 initial assessment

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

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hogzb Bpprox Hj	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	31.10.2024
Spain	Not recruiting	31.10.2024

Trial locations

Investigated drugs:

Mesenchymal Stromal Cells, Ex Vivo Cultured

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.

Investigated diseases:

Alveolar bone defect

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 ID:

2024-517976-39-00

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

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