Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

T.C. Dumlupınar Üniversitesi24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osseointegration Failure of Dental Implant Bone Density Increased

Interventions

Enamel Matrix ProteinDRUG

Enamel matrix derivated is used with transcrestal sinus lifting treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Gazi University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

endo-sinus bone gain

New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain

Time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)

Secondary Outcomes

radiographic measurements

The residual bone height (RBH)

Time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)

implant stability

resonance frequency analysis

Time frame: It will be measured at initiated at implant placement and third month follow-up

Radiographic measurements

implant protrusion length into the sinus

Time frame: CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)

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

Time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)

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

Time frame: Bone Density was measured at baseline, 3- and 12-months by CBCT scans

Data from ClinicalTrials.gov

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