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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: Completed NA study, sponsored by Harvard Medical School (HMS and HSDM).
NCT02404649 is a NA study that has completed, run by Harvard Medical School (HMS and HSDM). The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overa
Interventions
- DEVICE Two implant designs in a Sinus Bone Augmentation Procedure
- DEVICE Two implant designs in a Sinus Floor Elevation Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-07 |
| Est. Completion | 2017-12 |
| Phase | NA |
What the finished NCT02404649 record still lists
NCT02404649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02404649's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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