Clinical trial NCT02502058: Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Missing Teeth
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study subjects will include 40 healthy adult patients who seek dental implant placement to replace missing teeth in their mouths.

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.

Eligibility criteria: 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 suppressed
9. Patient with titanium allergy
10. Subject should not be a homeless person

Primary outcomes:
measure: Bone-ridge width before and immediately after preparation of the implant site when using the Densah Bur.
timeFrame: intraoperative
Secondary outcomes:
measure: insertion torque value (ITV)
timeFrame: intraoperative
measure: implant stability quotient (ISQ)
timeFrame: intraoperative , at 3 weeks and 6 weeks post surgery
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Patricia A Lenton, MA
role: PRINCIPAL_INVESTIGATOR
References: