Alveolar bone augmentation in patient with bone defects in jaw with < than 4 mm in lateral width
Conditions
Brief summary
Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 6 months after the regenerative surgery, immediately prior to implant placement.
Detailed description
Ability to place implants in the reconstructed area 6 months after the grafting procedure, Linear changes in mm measured with a gauge 2 mm below the alveolar crest, between the first surgery before applying the regenerative intervention and 6 months later at the second surgery, immediately before placing the implants, Adverse effects (AEs) and soft tissue healing (uneventful healing, wound dehiscence, membrane, exposure, redness, signs of infection, swelling) at 2 and 4 weeks and 6 months., Morbidity associated with procedures: o Number and type of postoperative anti-inflammatory medication o The degree of reported pain using a VAS scale., Patient’s satisfaction: - Patient reported outcomes (PROMs) using a structured questionnaire with Likert scales. - Patient’s overall quality of life (QoL) will be assessed with the use of validated tools: Health-related Quality of Life (HRQoL) and Oral Health-Related Quality of Life (OHRQoL)., Fate of the transplanted MSCs by liquid biopsy technology (screening, and 2 weeks after the bone augmentation) surgery by collecting peripheral blood samples and plasma/sera), Bone promoting activity of the intervention by evaluating the core biopsies harvested during re-entry procedure at the sites receiving dental implant by micro-computed tomography (μCT) and histology, The need of secondary bone augmentation around the dental implants placed in correct prosthetic driven position, Implant stability at time of implant installation, at abutment surgery, at loading, and 12 months after loading (using Osstell® radiofrequency implant stability quotients)., Evaluate local conditions, hygiene and absence of inflammation
Interventions
DRUGMesenchymal stem cells
Sponsors
University of Bergen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 6 months after the regenerative surgery, immediately prior to implant placement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ability to place implants in the reconstructed area 6 months after the grafting procedure, Linear changes in mm measured with a gauge 2 mm below the alveolar crest, between the first surgery before applying the regenerative intervention and 6 months later at the second surgery, immediately before placing the implants, Adverse effects (AEs) and soft tissue healing (uneventful healing, wound dehiscence, membrane, exposure, redness, signs of infection, swelling) at 2 and 4 weeks and 6 months., Morbidity associated with procedures: o Number and type of postoperative anti-inflammatory medication o The degree of reported pain using a VAS scale., Patient’s satisfaction: - Patient reported outcomes (PROMs) using a structured questionnaire with Likert scales. - Patient’s overall quality of life (QoL) will be assessed with the use of validated tools: Health-related Quality of Life (HRQoL) and Oral Health-Related Quality of Life (OHRQoL)., Fate of the transplanted MSCs by liquid biopsy technology | — |
Countries
Norway, Spain
Outcome results
None listed