Partially Edentulous JawNCT01821417
Performance of MicroTextured Dental Implants
A study testing Microtextured dental implant treatment and Dental implant treatment in people with Partially Edentulous Jaw, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partially Edentulous Jaw
- What is being tested?
- Microtextured dental implant treatment and Dental implant treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a current registered University of Alabama at Birmingham (UAB)dental school patient
- Existence of one or more missing teeth scheduled to be replaced with dental implants
- Healthy enough to undergo proposed therapy without compromising existing health
- Able to consent for their own inclusion
- Able to read and understand the informed consent form
- Demonstrated willingness to comply with protocol requirements and timeline
Who cannot join
- Any health condition that in the opinion of the investigators may adversely affect bone healing
- Any medication that in the opinion of the investigators may adversely affect bone healing
- Any indication of an inability to make autonomous decisions
- Reported pregnancy at the time of enrollment -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, 35294-0007
About this study
Official title: A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar
The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.
The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.
Read the detailed description
Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.
- Conditions
- Partially Edentulous Jaw
- Being tested
- Microtextured dental implant treatment, Dental implant treatment
- Keywords
- dental implants, screw-vent dental implants
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microtextured dental implant treatmentDevice
Also called Screw-vent dental implant
Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
Dental implant treatmentDevice
Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
| Study group | Role | What they receive |
|---|---|---|
| Microtextured dental implant | Experimental | Randomized for microtextured dental implant treatment Receives: Device: Microtextured dental implant treatment |
| Dental implant | Active comparator | Randomized dental implant treatment with machined-collar implants Receives: Device: Dental implant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Millimeters of Bone Loss Surrounding the Implant Device
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
Measured: Implant insertion, 12 months post-insertion
Secondary outcomes (2)
Changes in Peri-implant Gingivitis Score
Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration
Measured: 1 year after placement
Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.
Measured: 1 year after placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionJun 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partially Edentulous JawStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Dental
- Responsible party
- Principal investigator, Michael Reddy, DMD, University of Alabama at Birmingham
- Investigators
- Nicolaas C. Geurs, DDS.MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821417
- Sponsor's protocol ID
- Z-11
- Status last verified
- Jan 2017
- First submitted
- 13 Mar 2013
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar
- ClinicalTrials.gov ID
- NCT01821417
- Acronym / sponsor ID
- Z-11
- Conditions
- Partially Edentulous Jaw
- Keywords
- dental implants, screw-vent dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Zimmer Dental
- Study start
- May 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Posted 16 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.
The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.
Detailed description
Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microtextured dental implant | Experimental | Device: Microtextured dental implant treatmentRandomized for microtextured dental implant treatment |
| Dental implant | Active comparator | Device: Dental implant treatmentRandomized dental implant treatment with machined-collar implants |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be a current registered University of Alabama at Birmingham (UAB)dental school patient
- Existence of one or more missing teeth scheduled to be replaced with dental implants
- Healthy enough to undergo proposed therapy without compromising existing health
- Able to consent for their own inclusion
- Able to read and understand the informed consent form
Key exclusion criteria (4 listed)
- Any health condition that in the opinion of the investigators may adversely affect bone healing
- Any medication that in the opinion of the investigators may adversely affect bone healing
- Any indication of an inability to make autonomous decisions
- Reported pregnancy at the time of enrollment -
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 |
|---|---|---|
| Microtextured dental implant treatmentAlso: Screw-vent dental implantMicrotextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists. | Device | Microtextured dental implant |
| Dental implant treatmentTreatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists. | Device | Dental implant |
Primary outcome
Change in Millimeters of Bone Loss Surrounding the Implant Device
Time frame: Implant insertion, 12 months post-insertion
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
2 secondary outcomes
Changes in Peri-implant Gingivitis Score
Time frame: 1 year after placement
Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device
Time frame: 1 year after placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Partially Edentulous Jaw
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Active, not recruiting
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
RecruitingObservational study
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Tooth Loss, Alveolar Bone Loss
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
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.
Nicolaas C. Geurs, DDS.MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microtextured dental implant treatment and Dental implant treatment in people with Partially Edentulous Jaw, run by University of Alabama at Birmingham 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 16 Mar 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?
Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Millimeters of Bone Loss Surrounding the Implant Device (time frame: Implant insertion, 12 months post-insertion). 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 16 Mar 2017.