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A multicentre clinical trial: Alveolar bone augmentation using MSCs and biphasic calcium phosphate granules prior to dental implants (Behandling Maxillofacial)
EU CTIS ID: 2024-517976-39-00
What this study is testing
To assess the safety and efficacy of using autologous mesenchymal stem cells and biomaterials to regenerate bone in order to enable adequate implant placement.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent.
- Patient should be able to understand and complete the informed consent.
- Age 18 years or older.
- Insufficient bone ridge width (≤ than 4 mm) and or height at the recipient site for implant placement.
- Healthy oral mucosa, at least 2 mm keratinized mucosa.
- Female candidates of child bearing potential (WOCBP) -as defined by CTFG 2 (a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile due surgery)- must be referred to their physician for a pregnancy test 1,2 before inclusion in the study. (See the study protocol for full list of acceptable contraceptives and requirements for pregnancy testing during the study)
You likely can't join if
- General contraindications for dental and/or surgical treatments
- Concurrent or previous radiotherapy of head and neck region
- History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
- Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient`s history and concurrent HbA1c levels (HbA1c > 53 mmol/mol).
- Inflammatory and autoimmune disease of the oral cavity.
- Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
See the full eligibility criteria
Who can join
- Written informed consent.
- Patient should be able to understand and complete the informed consent.
- Age 18 years or older.
- Insufficient bone ridge width (≤ than 4 mm) and or height at the recipient site for implant placement.
- Healthy oral mucosa, at least 2 mm keratinized mucosa.
- Female candidates of child bearing potential (WOCBP) -as defined by CTFG 2 (a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile due surgery)- must be referred to their physician for a pregnancy test 1,2 before inclusion in the study. (See the study protocol for full list of acceptable contraceptives and requirements for pregnancy testing during the study)
- The WOCBP candidates will only be included in the study if the pregnency tests are negative. These patients must continue using the contraceptives until the placement of dental implants (6 months after bone augmentation procedure considering that pregnancy is not considered as a contraindication for normal dental implant).
- Female candidates that have entered menopause for less than 12 months must also be referred to confirm post-menopausal state by testing the level of follicle stimulating hormone (FSH).
What rules you out
- General contraindications for dental and/or surgical treatments
- Concurrent or previous radiotherapy of head and neck region
- History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
- Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient`s history and concurrent HbA1c levels (HbA1c > 53 mmol/mol).
- Inflammatory and autoimmune disease of the oral cavity.
- Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
- Patients with a history of drug addiction.
- Patients with known hypersensitivity against antibiotics (both Amoxicillin and Clindamycin), all painkillers (paracetamol, ibuprofen and level II painkillers) or xylocaine. Mouthwashes as chlorhexidine and anti-inflamatory agents will be used carefully considering possible allergies and contraindications for using these products.
- Thin keratinized mucosa (< 1mm)
- Current smokers and those who have quitted smoking in the last 4 weeks (there is evidence that nicotine and cotinine levels disappear after 4 weeks of non-smoking).
- Pregnant or lactating women.
- Participation in an investigational device, drug or biologics study within the last 24 weeks prior to the study start
- Contraindications for bone marrow harvesting (general):1) Patients with severe bone marrow diseases such as leukemias, lymphomas, and myelodysplastic syndromes. 2) Patients with severe respiratory disease, chronic respiratory failure, medical history of generalized allergic manifestation. 3) Patients with a history of severe osteoporosis. 4) Patients suffering from any serious coagulation disorders that could require substitution therapy. 5) Patients receiving anticouagulant treatment should be adjusted in collaboration with the treating physician.
- History of any malignant diseases
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.