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

NCT02502058 | Withdrawn

• 1 other identifier: University_of_Minnesota2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• insertion torque value (ITV)

  intraoperative

• implant stability quotient (ISQ)

  intraoperative , at 3 weeks and 6 weeks post surgery

Interventions

Densah Bur™ , osseodensification DEVICE

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.

Also known as: Versah Osseodensification Company™

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Males and females
• Ages 18-80 years of age
• Missing at least one tooth.
• Capable of giving informed consent

You may not qualify if:

• Patient is a pregnant female
• Patient smoking more than 5 cigarettes per day
• Patient has a history of alcoholism or drug abuse during the last 5 years
• Patient with uncontrolled hypertension or diabetes
• Patient has a malignant tumor
• Patient is on daily dose of steroids
• Patient with history of chemotherapy or radiation for the last 12 months
• Patient who is immuno suppressed
• Patient with titanium allergy
• Subject should not be a homeless person

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Oral Health Research Clinic at the School of Dentistry at the University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• Website for the manufacturer of the Densah Bur Technology

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Patricia A Lenton, MA

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 17, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)