Graft Materials, Sinus Lift, Transcrestal Approach
Conditions
Brief summary
Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla. Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. clinical study of 20 patients 13 in OSSIX Bone group 13 in Bio-Oss Collagen group all patients requiring a regenerative procedure (sinus lift) having less than 3mm of residual bone height (RBH) with the impossibility to place the implants at the time of regenerative proc 6 months follow up for the first endpoint. (collection of the histological sample) 12 months follow up - long term clinical evaluation. tests performed: Cone Beam Computed Tomography (CBCT), clinical evaluation, X-ray
Detailed description
Visit 1 - Screening Visit - preoperative visit (informed consent, dental mouth cleaning, CBCT, intraoral scanning). Visit 2 - Baseline visit - T0 (surgical procedure) Sinus elevation with OSSIX® Bone or Bio-Oss® Collagen, periapical x-ray, intraoral photo with microscope. Visit 3 - Follow up visit - 14 days - suture removal, clinical evaluation and patient satisfaction questionnaire. Visit 4 - Follow up visit - 180days (One week before) Cone Beam Computed Tomography (CBCT), Dental mouth cleaning, intraoral scanning. (Second surgery) implant site preparation and histological sample collection, implant placement, insertion torque value, implant stability, peri-apical x-ray, intraoral scanning and photography. Visit 5 - Follow up visit - 194 days suture removal and clinical evaluation. Visit 6 - Follow up visit - 270 days Implant stability, clinical examination, definitive restoration and periapical x-ray Visit 7- Follow up visit - 365 days Implant stability, peri-apical x-ray, definitive restoration, Cone Beam Computed Tomography (CBCT), intraoral scanning and picture.
Interventions
PROCEDUREmaxillary sinus elevation through transcrestal approach using OSSIX® Bone
After a careful radiologic analysis, using a surgical guide, maxillary sinus elevation through transcrestal access to sinus mucosa was achieved. The elevation of the maxillary sinus mucosa was performed through micro-elevators and graft material was inserted.
Sponsors
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
assessors analyzed blindly receiving anonymized bone samples and CBCT
Intervention model description
controlled clinical investigation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patient requiring vertical elevation of the maxillary sinus. 2. Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of \< 3-4 mm. 3. Males and females between 30-80 years old 4. Patients with healthy periodontal conditions (Treated periodontitis, Plaque Index (PI) \<25%, Bleeding on Probing (BoP) \<25%). 5. Patients that are willing to sign an informed consent and participate in a clinical Study. 6. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia. 7. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.
Exclusion criteria
1. Patient requiring vertical elevation of the maxillary sinus with native bone crest height \> 5 mm 2. Patients who smoke over 5 cigarettes/day 3. Pregnancy (confirmed by verbal inquiry) 4. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4. 5. Patients taking bisphosphonates 6. Any sites where an implant already failed sites 7. Untreated Periodontitis 8. Dental sites with acute infections 9. Chronic inflammatory diseases of the oral cavity 10. Autoimmune diseases (cortisone intake) 11. Allergy declared to one or more medicaments to be used during treatment 12. Alcoholics patients and/or drug addicts 13. Patients with known collagen hypersensitivity. 14. Patients with sensitivity to porcine-derived materials. 15. History or malignant tumors of the maxillary sinus 16. History of local radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| histological analysis | 6 months after graft insertion | samples were collected and histologically and immunohistologically analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radiological analyis | 12 months | preoperatively Cone Beam Computed Tomography (CBCT) was compared to 12 months CBCT. The volume of bone regeneration was measured by performing a semi-automatic segmentation using a specific segmentation software (3D Slicer) and measured in mm3. |
Countries
Italy
Outcome results
None listed