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

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.

Study Overview

• Status: Withdrawn
• Conditions: Missing Teeth
• Intervention / Treatment: Device: Densah Bur™ , osseodensification

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Oral Health Research Clinic at the School of Dentistry at the University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion torque value (ITV)	ITV is a measure of the rotational friction between the implant and the surrounding bone	intraoperative
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Patricia A Lenton, MA, University of Minnesota

Publications and helpful links

Helpful Links

• Website for the manufacturer of the Densah Bur Technology
• 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

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: University_of_Minnesota2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share study data.