A study to evaluate if the use of the patients own stem cells in combination with a biomaterial is as good as the standard treatment, bone transplantation.

Phase 1

• Conditions: Patients in need of dental implant(s) in the upper and lower jaws with presence of bone defects with loss in vertical height and < than 4 mm in lateral width; MedDRA version: 21.0Level: LLTClassification code 10005958Term: Bone disorder NOSSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2018-001227-39-DK
• Lead Sponsor: niversity of Bergen, Faculty of Medicin, Department of Clinical Dentistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-02
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

•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
titanium dental implant placement
? Patient should be eligible for bone marrow harvest and bone transplant
? Healthy oral mucosa, at least 2 mm keratinized mucosa
? Female candidates of child bearing potential (WOCBP) -as defined by CTFG 2- must be
referred to their physician for a pregnancy test 1,2 before inclusion in the study. In
case of a negative preganancy test their physician will be asked to prescribe one of
the highly effective birth control methods recommended by CTFG 2 which includes:
1. Combined estrogen and progestogen containing contraceptives that are
associated with inhibition of ovulation (oral, intravaginal or transdermal).
2. Progestogen-only hormonal contraceptives associated with inhibition of
ovulation (oral, injectable or implantable).
3. Intrauterine devices.
4. Intrauterine hormone-releasing system.
5. Bilateral tubal occlusion.
? 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 (5 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

General contraindications for dental and/or surgical treatments
· Contraindications for both bone marrow harvesting and bone grafts:
o General:
§ Patients with severe bone marrow diseases such as leukemias, lymphomas, and myelodysplastic syndromes.
§ Patients with severe respiratory disease, chronic respiratory failure, medical history of generalized allergic manifestation.
§ Patients with a history of severe osteoporosis.
§ Patients suffering from any serious coagulation disorders that could require substitution therapy.
§ Patients receiving anticouagulant treatment should be adjusted in collaboration with the treating physician.
§ Patients with total hip prothesis
o Local:
§ Patients with active infection at the harvest site
§ Patients with previous pathology or trauma at the harvest site
· History of any malignant diseases
· 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 paracetamol, codein or xylocaine.
· 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified