Clinical trial NCT05507047: Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osseointegration Failure of Dental Implant
Bone Density Increased
Keywords: enamel matrix derivated
maxillary sinus
Lead sponsor: T.C. Dumlupınar Üniversitesi
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* insufficient primary implant stability measured by RFA

Primary outcomes:
measure: endo-sinus bone gain
timeFrame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
Secondary outcomes:
measure: radiographic measurements
timeFrame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
measure: implant stability
timeFrame: It will be measured at initiated at implant placement and third month follow-up
measure: Radiographic measurements
timeFrame: CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)
measure: peri-implant sinus bone level
timeFrame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
measure: Densitometric Analysis
timeFrame: Bone Density was measured at baseline, 3- and 12-months by CBCT scans
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Dentistry
Study officials:
affiliation: Gazi University
name: Deniz Ozbay, DDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1563/aaid-joi-D-19-00119.