Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

Phase 4

Completed

• Conditions: Osseointegration Failure of Dental Implant; Bone Density Increased
• Interventions: Drug: Enamel Matrix Protein

• Registration Number: NCT05507047
• Lead Sponsor: T.C. Dumlupınar Üniversitesi

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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2020-01
• Study Completion: 2020-12
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-17
• Study First Posted: 2022-08-18
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcrestal Sinus Lifting with Emdogain	Enamel Matrix Protein	Osteotome sinus floor elevation with enamel matrix derivated
Transcrestal Sinus Lifting	Enamel Matrix Protein	Osteotome sinus floor elevation

Primary Outcome Measures

Name	Time	Method
endo-sinus bone gain	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 Outcome Measures

Name	Time	Method
radiographic measurements	CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)	The residual bone height (RBH)
Radiographic measurements	CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)	implant protrusion length into the sinus
implant stability	It will be measured at initiated at implant placement and third month follow-up	resonance frequency analysis
peri-implant sinus bone level	CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)	the distance between the groove most coronal to the implant and the bone-implant connection most apical to the implant
Densitometric Analysis	Bone Density was measured at baseline, 3- and 12-months by CBCT scans	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

Trial Locations

Locations (1)

Gazi University Faculty of Dentistry; 🇹🇷 Ankara, Turkey