Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

Study Overview
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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.

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.

Official Title
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The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant With Transcrestal Sinus Lifting Technique: Randomized-Controlled CBCT Study

Conditions
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Osseointegration Failure of Dental Implant, Bone Density Increased

Intervention / Treatment
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* Drug: Enamel Matrix Protein


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcrestal Sinus Lifting with Emdogain<br>Osteotome sinus floor elevation with enamel matrix derivated | Drug: Enamel Matrix Protein<br>* Enamel matrix derivated is used with transcrestal sinus lifting treatment<br>* Other names: emdogain;|
| Active Comparator: Transcrestal Sinus Lifting<br>Osteotome sinus floor elevation | Drug: Enamel Matrix Protein<br>* Enamel matrix derivated is used with transcrestal sinus lifting treatment<br>* Other names: emdogain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic measurements | The residual bone height (RBH) | CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2) | 
| implant stability | resonance frequency analysis | It will be measured at initiated at implant placement and third month follow-up | 
| Radiographic measurements | implant protrusion length into the sinus | 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 | 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 | Bone Density was measured at baseline, 3- and 12-months by CBCT scans | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enamel matrix derivated, maxillary sinus