Skip to main content
OpenTrials
Completed

NCT Number: NCT05507047

Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osseointegration Failure of Dental Implant Bone Density Increased Bone Diseases Bone Diseases, Developmental Musculoskeletal Diseases Osteochondrodysplasias Osteosclerosis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gazi University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enamel Matrix Protein

Drug

Enamel matrix derivated is used with transcrestal sinus lifting treatment

Other names: emdogain

Primary outcomes

  1. 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

  1. radiographic measurements

    Time frame: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)

    The residual bone height (RBH)

  2. implant stability

    Time frame: It will be measured at initiated at implant placement and third month follow-up

    resonance frequency analysis

  3. Radiographic measurements

    Time frame: CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)

    implant protrusion length into the sinus

  4. peri-implant sinus bone level

    Time frame: 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

  5. Densitometric Analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

T.C. Dumlupınar Üniversitesi

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 18, 2022
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.