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NCT02404649 · ClinicalTrials.gov registry record · NA

Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation

A NA study, sponsored by Harvard Medical School (HMS and HSDM).

Completed
Registry status
NA
Development phase
33
Enrollment target

NCT02404649 is a NA study that has completed, run by Harvard Medical School (HMS and HSDM). The registered enrollment target is 33 participants.

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The verdict

NCT02404649, a NA study, has completed, sponsored by Harvard Medical School (HMS and HSDM).

COMPLETED
Registry status
NA
Development phase
33 participants
Enrollment target

Study Summary

This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will enroll 30 active subjects who will receive two dental implants in the edentulous maxillary molar region. This 24-month research study will examine the clinical stability of TMDI in both sinus elevation and sinus augmentation environments. The proposed research lays the foundation for improved health care by providing surgeons and restorative dentists with data for determining the effects TMDI have on clinical success in less than optimal osseous environments. The rationale that underlies the investigation is that identification of the influences of trabecular surface design on implant stability in varying bone types will allow routine, predictable use of early loading, which, in turn, will translate into more rapid, economical health care, and improved psychosocial well-being of the patient. If these hypotheses are correct, the results are expected to provide evidence based research data to support early loading and immediate loading of single implants in sites of adequate bone volume, and density with or without the use of graft materials in sinus lift procedures. In addition, it is expected that these results will fundamentally advance the field of implant dentistry and bioengineering by providing information on the principles of the bone density-mechanical environment-implant stability interaction.

Interventions

  • DEVICE Two implant designs in a Sinus Bone Augmentation Procedure
  • DEVICE Two implant designs in a Sinus Floor Elevation Procedure

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2012-07
Est. Completion 2017-12
Phase NA

What the Registry Record Tells You About NCT02404649

The ClinicalTrials.gov registry entry for NCT02404649 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Harvard Medical School (HMS and HSDM), which has 26 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Two implant designs in a Sinus Bone Augmentation Procedure is the first listed.

NCT02404649 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02404649 about?

NCT02404649 is a clinical study titled "Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation". This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will enroll 30 active subjects who will receive two dental implants in the edentulous maxillary molar region. This 24-mon...

What is the current status of trial NCT02404649?

This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2012-07. Estimated completion is 2017-12.

What interventions are being tested in trial NCT02404649?

The interventions under investigation include: Two implant designs in a Sinus Bone Augmentation Procedure (DEVICE), Two implant designs in a Sinus Floor Elevation Procedure (DEVICE).

Who is sponsoring clinical trial NCT02404649?

This trial is sponsored by Harvard Medical School (HMS and HSDM), which has 26 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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