Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

Osseointegration Failure of Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05507047
• Other study ID #: 14/4
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: August 2022
• Source: T.C. Dumlupinar Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 ?oor 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

Related Conditions & MeSH terms

• Bone Density Increased
• Osseointegration Failure of Dental Implant

Intervention

Drug:
• Enamel Matrix Protein
Enamel matrix derivated is used with transcrestal sinus lifting treatment

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
T.C. Dumlupinar Üniversitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Vincent-Bugnas S, Charbit Y, Charbit M, Dard M, Pippenger B. Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative: A Human Randomized Controlled Clinical and Histologic Study. J Oral Implantol. 2020 Oct 1;46(5):507-513. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	radiographic measurements	The residual bone height (RBH)	CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
Secondary	implant stability	resonance frequency analysis	It will be measured at initiated at implant placement and third month follow-up
Secondary	Radiographic measurements	implant protrusion length into the sinus	CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)
Secondary	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)
Secondary	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

External Links

•   Effect of enamel matrix derivative on alveolar ridge preservation in the posterior maxilla
•   Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative