At the department Cranio-Maxillofacial Surgery of Maastricht University Medical Center (MUMC) the routine procedure for sinus floor elevation prior to dental implant insertion is augmentation with a mixture of autogenous bone and xenogenous bone, which adds morbidity due to the donorsite. We want to augment the maxillary sinuses without using any substitutes by placing only a resorbable barrier to elevate the Schneiderian membrane of the floor of the sinus. Bone will be regenerated using the pe
Conditions
Interventions
With this study we want to evaluate the bone quantity and quality after periosteal elevation of the Schneiderian membrane. We want to compare these results with sinus augmentation with a mixture of au
Sponsors
Maastricht University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18-75 years old; 2. Edentulous; 3. Residual bone heights of 1-8 mm; 4. Bone width of at least 5 mm.
Exclusion criteria
Exclusion criteria: 1. Contraindications for general anaesthesia; 2. History of radiotherapy in the head/neck region; 3. Treated with bisphosphonates; 4. Poor oral hygiene; 5. Uncontrolled diabetes; 6. Pregnancy; 7. Infection; 8. Increased tendency to hemorrhages.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CBCT: Computed tomographic follow-up is used for the evaluation of the bone amount and quality (28). A cone beam computed tomography (CBCT) will be made pre-operatively. Four months postoperative a CBCT will be made. This will be necessary prior to implant insertion regardless to the chosen technique of augmentation. On this scan a direct comparison of bone height and volume can be made between the two augmented sinuses. Inserting implants in the maxilla follows this procedure. Four months after placing the implants a CBCT will be made to evaluate the bone quality surrounding the implants. Histology: During the regular procedure of implant insertion a canal must be drilled. During this study we will use the bone that is removed before insertion for histological research. Instead of using a solid burr for the preparation of the implant beds, we will use a trephine burr (diameter 3.5mm). This is a hollow shaped burr that allows us to take a bone core for histological evaluation before implant placement. No bone loss or extra defects are created. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are implant survival, prosthetic rehabilitation and patient’s satisfaction. We will also observe the appearance of complications like infection, bleeding and pain. | — |
Contacts
Public ContactS.A.N. Lie
University Medical Center P. Debyelaan 25 Postbus 5800
Outcome results
None listed