Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osseointegration Failure of Dental Implant Bone Density Increased

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transcrestal Sinus Lifting with Emdogain

Osteotome sinus floor elevation with enamel matrix derivated

Group Type EXPERIMENTAL

Enamel Matrix Protein

Intervention Type DRUG

Enamel matrix derivated is used with transcrestal sinus lifting treatment

Transcrestal Sinus Lifting

Osteotome sinus floor elevation

Group Type ACTIVE_COMPARATOR

Enamel Matrix Protein

Intervention Type DRUG

Enamel matrix derivated is used with transcrestal sinus lifting treatment

Interventions

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Enamel Matrix Protein

Enamel matrix derivated is used with transcrestal sinus lifting treatment

Intervention Type DRUG

Other Intervention Names

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emdogain

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes