Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Density Increased; Osseointegration Failure of Dental Implant
• Intervention / Treatment: Drug: Enamel Matrix Protein

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Gazi University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: T.C. Dumlupınar Üniversitesi
• Investigators: Principal Investigator: Deniz Ozbay, DDS PhD, Gazi University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: enamel matrix derivated; maxillary sinus
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Osteochondrodysplasias; Osteosclerosis
• Other Study ID Numbers: 14/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No