Peri-implantitisNCT01870349
A Comparison of Inflammatory Mediators Surrounding Titanium or Zirconium Implant Abutments
An observational study of Peri-implantitis, run by Christopher Barwacz at 1 site in United States.
Trial summary
The purpose of this study is to determine whether there are differences in inflammatory markers and bone-mediator protein expression in the fluid surrounding implant abutments manufactured with either titanium or zirconium. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Gingival Crevicular Fluid Sampling
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2011
- 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: Community sample, dental clinic patients
Who may be able to join
- presence of a single-tooth implant-supported restoration bounded by natural teeth in stable occlusion
- pre-fabricated or computer aided design and computer aided manufactured (CAD/CAM) transmucosal abutments of either commercially-pure titanium dioxide or zirconium dioxide
- a minimum of 6 months of clinical function in situ.
Who cannot join
- subjects who are pregnant
- immunosuppressed subjects
- diabetes
- smokers
- alcohol or drug abuse
- systemic anti-inflammatory medication use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry
Iowa City, Iowa, 52242
About this study
Official title: Evaluation of Pro-inflammatory Mediators Around Astra Tech Dental Implant Abutments Following a Minimum of 6 Months of Clinical Function
The purpose of this study is to determine whether there are differences in inflammatory markers and bone-mediator protein expression in the fluid surrounding implant abutments manufactured with either titanium or zirconium.
Read the detailed description
The aim of this cross-sectional study is to utilize the paper strip-based peri-implant crevicular fluid (PICF) sampling technique to evaluate the influence that transmucosal abutment biomaterials of either titanium or zirconium oxide, which have been in situ for greater than six months, have in the expression of specific pro-inflammatory and bone-mediators.
Subjects who had previously undergone single-tooth implant replacement therapy are invited to participate and informed consent is obtained.
All participants receive a clinical and radiographic exam of the implant site that is sampled for PICF. Clinical and radiographic parameters such as implant mobility, presence or absence of supragingival plaque, and interproximal bone levels were assessed. Peri-apical radiographs, utilizing a paralleling technique, will be obtained from each implant fixture to evaluate the marginal bone level compared to baseline periapical radiographs made at the time of definitive prosthesis delivery. Each participant's implant site is isolated with cotton rolls, light air is applied over the site to eliminate the potential for ambient salivary contamination of the PICF sample. The implant site is sampled for 30 seconds at four distinct sites (mesio-buccal, disto-buccal, mesio-lingual, disto-lingual) by one clinician under loupe magnification. The fluid volumes collected on each strip will be quantified using the Periotron 8000 Instrument.
Cytokine, chemokine, and bone mediator quantities (pg/30 s) were determined using a commercial 22-multiplexed fluorescent bead-based immunoassay. Two specific multiplex kits are utilized (Milliplex MAP Human cytokine/Chemokine Immunoassay \& Milliplex MAP Human Bone Panel 1B Immunoassay).
Biostatisticians are masked to the implant abutment biomaterial designations (masked as "A" and "B") during data analysis. Initial bivariate analysis using the Wilcoxon-Mann-Whitney (Wilcoxon Rank Sum) test will be employed to assess the difference in distribution between the two groups (titanium dioxide or zirconium oxide) for each cytokine/bone mediator and for age. The same approach is used to consider whether a gender difference was associated with a particular cytokine/bone mediator. Gender distribution in the two groups will be compared using the Fisher exact test. The Spearman rank correlation will be used to assess the possibility of a relationship with age for each cytokine. Rank-based regression models will be used to adjust for possible effects of age and gender for both cytokine and bone mediator levels.
- Conditions
- Peri-implantitis
- Being tested
- Gingival Crevicular Fluid Sampling
- Keywords
- cytokines, dental implants, peri-implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Crevicular Fluid SamplingProcedure or surgery
Gingival crevicular fluids will be sampled from single implant restorations that have been in function for at least 6 months
| Study group | Role | What they receive |
|---|---|---|
| Titanium Implant Abutments | Gingival Crevicular Fluid Sampling Receives: Procedure: Gingival Crevicular Fluid Sampling | |
| Zirconium Implant Abutments | Gingival Crevicular Fluid Sampling Receives: Procedure: Gingival Crevicular Fluid Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of pro-inflammatory and bone mediators (pg/30 seconds) surrounding titanium vs. zirconium abutments
Levels of pro-inflammatory and bone mediators
Measured: At least 6 months post crown placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Barwacz
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables, University of Iowa
- Responsible party
- Sponsor-investigator, Christopher Barwacz, University of Iowa
- Investigators
- Chris A Barwacz, DDS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870349
- Sponsor's protocol ID
- 200911729
- Status last verified
- Feb 2018
- First submitted
- 30 May 2013
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pro-inflammatory Mediators Around Astra Tech Dental Implant Abutments Following a Minimum of 6 Months of Clinical Function
- ClinicalTrials.gov ID
- NCT01870349
- Acronym / sponsor ID
- 200911729
- Conditions
- Peri-implantitis
- Keywords
- cytokines, dental implants, peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Christopher BarwaczUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables, University of Iowa
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Jun 2013 (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 purpose of this study is to determine whether there are differences in inflammatory markers and bone-mediator protein expression in the fluid surrounding implant abutments manufactured with either titanium or zirconium.
Detailed description
The aim of this cross-sectional study is to utilize the paper strip-based peri-implant crevicular fluid (PICF) sampling technique to evaluate the influence that transmucosal abutment biomaterials of either titanium or zirconium oxide, which have been in situ for greater than six months, have in the expression of specific pro-inflammatory and bone-mediators.
Subjects who had previously undergone single-tooth implant replacement therapy are invited to participate and informed consent is obtained.
All participants receive a clinical and radiographic exam of the implant site that is sampled for PICF. Clinical and radiographic parameters such as implant mobility, presence or absence of supragingival plaque, and interproximal bone levels were assessed. Peri-apical radiographs, utilizing a paralleling technique, will be obtained from each implant fixture to evaluate the marginal bone level compared to baseline periapical radiographs made at the time of definitive prosthesis delivery. Each participant's implant site is isolated with cotton rolls, light air is applied over the site to eliminate the potential for ambient salivary contamination of the PICF sample. The implant site is sampled for 30 seconds at four distinct sites (mesio-buccal, disto-buccal, mesio-lingual, disto-lingual) by one clinician under loupe magnification. The fluid volumes collected on each strip will be quantified using the Periotron 8000 Instrument.
Cytokine, chemokine, and bone mediator quantities (pg/30 s) were determined using a commercial 22-multiplexed fluorescent bead-based immunoassay. Two specific multiplex kits are utilized (Milliplex MAP Human cytokine/Chemokine Immunoassay \& Milliplex MAP Human Bone Panel 1B Immunoassay).
Biostatisticians are masked to the implant abutment biomaterial designations (masked as "A" and "B") during data analysis. Initial bivariate analysis using the Wilcoxon-Mann-Whitney (Wilcoxon Rank Sum) test will be employed to assess the difference in distribution between the two groups (titanium dioxide or zirconium oxide) for each cytokine/bone mediator and for age. The same approach is used to consider whether a gender difference was associated with a particular cytokine/bone mediator. Gender distribution in the two groups will be compared using the Fisher exact test. The Spearman rank correlation will be used to assess the possibility of a relationship with age for each cytokine. Rank-based regression models will be used to adjust for possible effects of age and gender for both cytokine and bone mediator levels.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium Implant Abutments | – | Procedure: Gingival Crevicular Fluid SamplingGingival Crevicular Fluid Sampling |
| Zirconium Implant Abutments | – | Procedure: Gingival Crevicular Fluid SamplingGingival Crevicular Fluid Sampling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample, dental clinic patients
Key inclusion criteria (3 listed)
- presence of a single-tooth implant-supported restoration bounded by natural teeth in stable occlusion
- pre-fabricated or computer aided design and computer aided manufactured (CAD/CAM) transmucosal abutments of either commercially-pure titanium dioxide or zirconium dioxide
- a minimum of 6 months of clinical function in situ.
Key exclusion criteria (6 listed)
- subjects who are pregnant
- immunosuppressed subjects
- diabetes
- smokers
- alcohol or drug abuse
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 |
|---|---|---|
| Gingival Crevicular Fluid SamplingGingival crevicular fluids will be sampled from single implant restorations that have been in function for at least 6 months | Procedure or surgery | Titanium Implant Abutments, Zirconium Implant Abutments |
Primary outcome
Levels of pro-inflammatory and bone mediators (pg/30 seconds) surrounding titanium vs. zirconium abutments
Time frame: At least 6 months post crown placement
Levels of pro-inflammatory and bone mediators
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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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.
Chris A Barwacz, DDS principal investigator
University of Iowa
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 Peri-implantitis, run by Christopher Barwacz 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 3 inclusion and 6 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 27 Feb 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Levels of pro-inflammatory and bone mediators (pg/30 seconds) surrounding titanium vs. zirconium abutments (time frame: At least 6 months post crown placement). 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 27 Feb 2018.