Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-04 @ 4:50 PM
Study NCT ID:
NCT02502058
Status:
WITHDRAWN
Last Update Posted:
2017-06-20
First Post:
2015-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Observational, Case-Series Study Evaluation of Bone Width and Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites
Status:
WITHDRAWN
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator left her employment at the University.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine if the use of a bone compaction process (osseodensification) (Densah™ bur: Versah Osseodensification Company™) to prepare dental implant sites, in human subjects, results in increased bone-ridge width, increased compact bone in the outer wall of the prepared sites, and dental implant stability.
Detailed Description:
The proposed project will be an observational, case-series study. The investigators anticipate enrolling 40 study subjects. Treatment Procedures: Following initial treatment planning discussions between the dentists and their patients regarding all of their dental treatment options, those patients who opt to have dental implants placed will be approached to discuss participation in the current study. Before entry into the study, the Investigator or an authorized member of the investigational staff will explain to potential subjects the aims, methods, reasonable anticipated benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be informed that their participation is voluntary and that they may withdraw consent to participate at any time. They will be informed that choosing not to participate will not affect the care the subject will receive for the treatment of their condition. Subjects will be told that alternative treatments are available and that if they decline to take part in the present study that such a refusal will not prejudice future treatment. Those patients who are willing to participate will be scheduled for their initial and follow-up dental implant visits at the School of Dentistry. At the baseline visit the study outcome data will be collected; including: 1) measuring the bone-ridge width, before and after implant site preparation (drilling); 2) intraoral photographs of the prepared opening; 3) dental implant torque readings will be obtained; and 4) ISQ as measure of both initial and the dynamic development of osseointegration (the formation of a direct interface between the dental implant and bone) over time. The ISQ measurements will be collected again at three and six-weeks post treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: