Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites
Status: | Enrolling by invitation |
---|---|
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | July 2015 |
End Date: | July 2016 |
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
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.
(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.
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 SOD. 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.
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 SOD. 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.
Inclusion Criteria:
1. Males and females
2. Ages 18-80 years of age
3. Missing at least one tooth.
4. Capable of giving informed consent
Exclusion Criteria:
1. Patient is a pregnant female
2. Patient smoking more than 5 cigarettes per day
3. Patient has a history of alcoholism or drug abuse during the last 5 years
4. Patient with uncontrolled hypertension or diabetes
5. Patient has a malignant tumor
6. Patient is on daily dose of steroids
7. Patient with history of chemotherapy or radiation for the last 12 months
8. Patient who is immuno supressed
9. Patient with titanium allergy
10. Subject should not be a homeless person
We found this trial at
1
site
Minneapolis, Minnesota 55455
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