Bone Density Increased, Osseointegration Failure of Dental Implant
Conditions
Keywords
enamel matrix derivated, maxillary sinus
Brief summary
The aim of this study is to evaluate the clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with and without simultaneous enamel matrix derivative (EMD) application.
Detailed description
Twenty-four patients will be randomly assigned into two groups: Group I: (EMD+OSFE) (n=20 implants, 13 patients) OSFE with EMD application, and Group II 8OSFE): (n=20 implants, 11 patients) OSFE without EMD application. The patients will be recall at 3- and 12- months after surgery. The residual bone height (RBH), implant protrusion length (IPL), peri-implant sinus bone level (SBL), endo-sinus bone gain (ESBG), implant stability and peri-implant bone density values (Hounsfield units) will be assessed.
Interventions
DRUGEnamel Matrix Protein
Enamel matrix derivated is used with transcrestal sinus lifting treatment
Sponsors
T.C. Dumlupınar Üniversitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* partial edentulism in the maxillary posterior region for at least 4 months from tooth loss and require implant treatment * adequate bone thickness for primary stabilization * residual bone height ranged from 4 mm to 6 mm * systemic and local conditions compatible with implant placement and sinus floor elevation * antagonist teeth
Exclusion criteria
* uncontrolled diabetes mellitus or other systemic disorders (such as; hepatitis, tuberculosis, AIDS) * pregnancy * untreated periodontal disease * endodontic lesions or other oral disorders * heavy smokers (≥10 cigarettes per day) * acute or chronic rhinitis * sinusitis or pathology in sinus * inadequate residual bone height and quality to achieve implant stability * previous implant treatment/failure or bone augmentation in the implant site * sinus perforation as confirmed via Valsalva maneuver * insufficient primary implant stability measured by RFA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endo-sinus bone gain | CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2) | New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radiographic measurements | CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2) | The residual bone height (RBH) |
| implant stability | It will be measured at initiated at implant placement and third month follow-up | resonance frequency analysis |
| Radiographic measurements | CBCT will be evaluated at initiation of study (T0), and at 12th month (T2) | implant protrusion length into the sinus |
| peri-implant sinus bone level | CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2) | the distance between the groove most coronal to the implant and the bone-implant connection most apical to the implant |
| Densitometric Analysis | Bone Density was measured at baseline, 3- and 12-months by CBCT scans | CBCT allows sectional analysis. Each axial image is 260000 megapixels, and each pixel has a CT number (Hounsfield unit). The higher the CT number, the denser the object |
Countries
Turkey (Türkiye)
Outcome results
None listed