Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites

Missing Teeth Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02502058
• Other study ID #: University_of_Minnesota2
• Status: Withdrawn
• Phase: N/A
• First received: July 10, 2015
• Last updated: June 16, 2017
• Start date: July 2015
• Est. completion date: March 2017

Study information

• Verified date: June 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

Device:
• Densah Bur™ , osseodensification
Densah™ bur (Versah Osseodensification Company™) is used to prepare dental implant sites, in human subjects, by compacting (osseodensification ) bone vs. removing bone to create the opening in the jaw bone into which the dental implant is then placed. This osseodensification process results in increased bone-ridge width, increased compact bone in the outer wall of the prepared sites, and; it is believed, increases implant stability.

Locations

Country	Name	City	State
United States	Oral Health Research Clinic at the School of Dentistry at the University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone-ridge width before and immediately after preparation of the implant site when using the Densah Bur.	The width of the bony ridge into which the dental implant will be placed will be measured immediately before drilling the opening with the Densah Bur and then again following completion of drilling but before the dental implant is placed into the prepared opening. These measurements will occur at the time of the implant surgery.	intraoperative
Secondary	insertion torque value (ITV)	ITV is a measure of the rotational friction between the implant and the surrounding bone	intraoperative
Secondary	implant stability quotient (ISQ)	ISQ uses resonance frequency analysis to determine if the newly prepared implant site is stable enough for immediate or early loading of the actual dental implant.	intraoperative , at 3 weeks and 6 weeks post surgery

External Links

•   DentalXP online Community; dentists contribute, discuss, and interact with dentists from across the globe. They post their cases, questions, experiences and share solutions for the advancement of the science and clinical practice of Den
•   Website for the manufacturer of the Densah Bur Technology