The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant With Transcrestal Sinus Lifting Technique: Randomized-Controlled CBCT Study
Overview
- Phase
- Phase 4
- Intervention
- Enamel Matrix Protein
- Conditions
- Osseointegration Failure of Dental Implant
- Sponsor
- T.C. Dumlupınar Üniversitesi
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- endo-sinus bone gain
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Berceste Guler
Assoc Prof
T.C. Dumlupınar Üniversitesi
Eligibility Criteria
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
Arms & Interventions
Transcrestal Sinus Lifting with Emdogain
Osteotome sinus floor elevation with enamel matrix derivated
Intervention: Enamel Matrix Protein
Transcrestal Sinus Lifting
Osteotome sinus floor elevation
Intervention: Enamel Matrix Protein
Outcomes
Primary Outcomes
endo-sinus bone gain
Time Frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain
Secondary Outcomes
- radiographic measurements(CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2))
- Radiographic measurements(CBCT will be evaluated at initiation of study (T0), and at 12th month (T2))
- implant stability(It will be measured at initiated at implant placement and third month follow-up)
- peri-implant sinus bone level(CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2))
- Densitometric Analysis(Bone Density was measured at baseline, 3- and 12-months by CBCT scans)