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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source T.C. Dumlupinar Üniversitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Enamel Matrix Protein
Enamel matrix derivated is used with transcrestal sinus lifting treatment

Locations

Country Name City State
Turkey Gazi University Faculty of Dentistry Ankara

Sponsors (1)

Lead Sponsor Collaborator
T.C. Dumlupinar Üniversitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

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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