Missing TeethNCT02502058
Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites
An observational study of Missing Teeth, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Densah Bur™ , osseodensification
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study subjects will include 40 healthy adult patients who seek dental implant placement to replace missing teeth in their mouths.
Who may be able to join
- Males and females
- Ages 18-80 years of age
- Missing at least one tooth.
- Capable of giving informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
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.
Read the 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.
- Conditions
- Missing Teeth
- Being tested
- Densah Bur™ , osseodensification
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah Bur™ , osseodensificationDevice
Also called Versah Osseodensification Company™
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
Secondary outcomes (2)
insertion torque value (ITV)
ITV is a measure of the rotational friction between the implant and the surrounding bone
Measured: 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.
Measured: intraoperative , at 3 weeks and 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Principal Investigator left her employment at the University.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia A Lenton, MA, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502058
- Sponsor's protocol ID
- University_of_Minnesota2
- Status last verified
- Jun 2017
- First submitted
- 10 Jul 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share study data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02502058
- Acronym / sponsor ID
- University_of_Minnesota2
- Conditions
- Missing Teeth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left her employment at the University.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects will include 40 healthy adult patients who seek dental implant placement to replace missing teeth in their mouths.
Key inclusion criteria (4 listed)
- Males and females
- Ages 18-80 years of age
- Missing at least one tooth.
- Capable of giving informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Densah Bur™ , osseodensificationAlso: Versah Osseodensification Company™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. | Device | – |
Primary outcome
Bone-ridge width before and immediately after preparation of the implant site when using the Densah Bur.
Time frame: intraoperative
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.
2 secondary outcomes
insertion torque value (ITV)
Time frame: intraoperative
implant stability quotient (ISQ)
Time frame: intraoperative , at 3 weeks and 6 weeks post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Website for the manufacturer of the Densah Bur TechnologyLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share study data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Lenton, MA principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Missing Teeth, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone-ridge width before and immediately after preparation of the implant site when using the Densah Bur. (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.