Osseointegration Failure of Dental Implant Clinical Trial
Official title:
The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant With Transcrestal Sinus Lifting Technique: Randomized-Controlled CBCT Study
NCT number | NCT05507047 |
Other study ID # | 14/4 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | December 2020 |
Verified date | August 2022 |
Source | T.C. Dumlupinar Üniversitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 ?oor 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University Faculty of Dentistry | Ankara |
Lead Sponsor | Collaborator |
---|---|
T.C. Dumlupinar Üniversitesi |
Turkey,
Vincent-Bugnas S, Charbit Y, Charbit M, Dard M, Pippenger B. Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative: A Human Randomized Controlled Clinical and Histologic Study. J Oral Implantol. 2020 Oct 1;46(5):507-513. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | endo-sinus bone gain | New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain | CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2) | |
Secondary | radiographic measurements | The residual bone height (RBH) | CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2) | |
Secondary | implant stability | resonance frequency analysis | It will be measured at initiated at implant placement and third month follow-up | |
Secondary | Radiographic measurements | implant protrusion length into the sinus | CBCT will be evaluated at initiation of study (T0), and at 12th month (T2) | |
Secondary | peri-implant sinus bone level | the distance between the groove most coronal to the implant and the bone-implant connection most apical to the implant | CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2) | |
Secondary | Densitometric Analysis | 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 | Bone Density was measured at baseline, 3- and 12-months by CBCT scans |
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