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
Conditions
Sponsors
University of Bergen, Faculty of Medicin, Department of Clinical Dentistry
Eligibility
Sex/Gender
All
Inclusion criteria
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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal objective: To compare linear changes in bone width between the tested interventions aimed for vertical and lateral bone augmentation; test (combination of autologous culture expanded mesenchymal stem cells and biomaterials) and control groups (autologous bone block graft from ramus fixed with osteosynthesis screws);Secondary Objective: (1) To evaluate efficacy of treatment and formation of new bone by: assessing the possibility to insert an implant 5 months after the grafting procedure (3D CBCT) Measuring clinical changes in alveolar bone width. evaluating the collected core biopsies using µCT, SRµCT and histology. evaluting outcomes after implant placement (2) To evaluate the safety of the interventions by: assessing adverse effects (AEs) and soft tissue healing at 2 and 4 weeks and 5 months assessing the morbidity associated with both procedures by measuring the usage of postoperative anti-inflammatory medication and degree of reported pain using a VAS scale assessing fate of the transplanted MSCs by liquid biopsy (blood samples and plasma/sera at screening and 2 weeks after bone augmentation surgery) (3) To assess patient’s satisfaction with surgical intervention and prosthetic outcome by patient reported outcomes (PROMs). Impact of treatment on the patient’s overall quality of life (QoL) will be assessed;Primary end point(s): Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 5 months after the regenerative surgery, immediately prior to implant placement. ;Timepoint(s) of evaluation of this end point: After 5,5 +- 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PROMS, implant stability, QoL, AE assessment;Timepoint(s) of evaluation of this end point: At 21 months. | — |
Countries
Denmark, Norway, Spain
Contacts
Public ContactCecilie Gjerde
University of Bergen, Faculty of Medicin, Department of Clinical Dentistry
Outcome results
None listed