Bone Substitutes, Calcium Phosphates, Hydroxyapatite, Rhodophyta, Sinus Floor Augmentation
Conditions
Brief summary
Twenty patients scheduled for lateral-window sinus floor Elevation (SFE) are randomized into two groups: use of SYMBIOS® Biphasic Bone Graft Material (Group 1) or of Algipore® Bone Substitution Material (Group 2). Biopsies are taken 3 months after SFE and during implant surgery after 6 months. One ground section per biopsy (n=40) is stained, scanned, and histomorphometrically analyzed for new bone, old bone, soft tissue, graft, bone infiltration of graft, bone-to-graft contact, and penetration depth.
Interventions
DEVICEUse of Symbios Bone Graft Material
Patients will receive Symbios Bone Graft Material according to randomization Group.
DEVICEAlgipore Bone Substitution Material
Patients will receive Algipore Bone Substitution Material according to randomization Group.
Sponsors
Dentsply Sirona Implants and Consumables
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Capability of giving an informed consent 2. Good health as defined by the subject's medical history 3. Patients age 20-75 years 4. Fully edentulous or partially edentulous patients with unilateral or bilateral missing teeth in the maxillary premolar or molar areas with severe alveolar atrophy and a residual alveolar ridge height of maximal 5 mm requiring a two-staged sinus floor elevation and implant placement.
Exclusion criteria
1. Patients without detailed baseline medical data 2. Patients with medical history of local inflammations in the posterior maxilla 3. Skeletal immaturity 4. Patients with osteoporosis in their medical history 5. Patients with severe illnesses, malignant diseases, radiotherapy or chemotherapy in their medical history 6. Patients with pathological fractures 7. Patients treated with bisphosphonates 8. Uncontrolled diabetes mellitus 9. Uncontrolled periodontal diseases 10. Smoking 11. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability | 12 months after sinus augmentation | measured with Periotest® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing on depth | 24 months after sinus augmentation | The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head |
| Bleeding on probing | 24 months | — |
| Crestal bone level after implant | 12 months after implant placement | measured by means of single tooth x-rays |
| Complications | 6 months after sinus augmentation | Frequency of complications |
| Newly formed bone area in mm² | 3 months after sinus augmentation | measured through histomorphological analysis |
| Survival rate of the implants | 24 months after sinus augmentation | Rate of loss of implants |
| Tissue area in mm² | 3 months after sinus augmentation | measured through histomorphological analysis |
| Bone substitute area in mm² | 3 months after sinus augmentation | measured through histomorphological analysis |
| New bone infiltration area in bone substitute in mm² | 3 months after sinus augmentation | measured through histomorphological analysis |
| new bone to bone substitute contact in mm | 6 months after sinus augmentation | measured through histomorphological analysis |
| Penetration depth in mm | 3 months after sinus augmentation | measured through histomorphological analysis |
| Old bone area in mm² | 3 months after sinus augmentation | measured through histomorphological analysis |
Outcome results
None listed