Periodontal DiseaseCirCoNCT01154855
Periodontal Disease and Circulatory Microbial Components
An observational study of Periodontal Disease, run by University of Michigan.
Trial summary
The goal of this project is to study the immune activity of certain proteins present in the blood of patients with severe periodontal disease. Periodontal disease (gum disease) is the major cause of tooth loss among adults. Moderate to severe periodontal disease is reported to affect 5-15% of American adults. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Prophylaxis ; Gross debridement for diseased patients
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to May 2015
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 adult subjects comprised of two populations: 1) healthy (n=20) and 2) severe periodontal disease (n=20)
Who may be able to join
- 35 years or older
- Healthy patients or patients with severe periodontal disease
- Patients with or without Rheumatoid Arthritis
- Patients with at least 20 permanent teeth
Who cannot join
- Patients undergoing long-term (over 2 weeks) antibiotic-related therapy 3 months prior to study inclusion
- Patients receiving periodontal treatment 12 months prior to study inclusion (INCLUDING CLEANINGS)
- Patients will be excluded if they receive long-term use of medications known to affect periodontal status such as anti-inflammatory drugs, aspirin and ibuprofen
- Patients on immunosuppressive therapies, including glucocorticoids or cyclosporines, are excluded from participation in this study (inhalers are allowed)
- History of metabolic bone diseases such as rheumatoid arthritis or post-menopausal osteoporosis
- Pregnant women or women attempting to become pregnant
About this study
Official title: Circulatory Microbial Components and Immune Regulators of Patients With Periodontal Disease and Rheumatoid Arthritis
The goal of this project is to study the immune activity of certain proteins present in the blood of patients with severe periodontal disease. Periodontal disease (gum disease) is the major cause of tooth loss among adults. Moderate to severe periodontal disease is reported to affect 5-15% of American adults. It begins with an infection of the tissues surrounding the teeth, and leads to a worsening inflammatory response. This study will aid in clarifying the way in which gum disease might affect certain systemic diseases.
Read the detailed description
This project will have two specific goals: 1. Identify microorganism components in the serum of patients with severe periodontitis; and 2. Characterize the immune regulator activity of periodontitis serum. This proposed feasibility study will then aid in providing the support for an increased sample size and other design requirements for larger, more expanded human clinical trial testing.In this study, forty (40) subjects will be divided into 2 groups: 1) Healthy oral status group and 2) Severe periodontal disease. Patients will be clinically screened using standard periodontal measurements.
- Conditions
- Periodontal Disease
- Being tested
- Prophylaxis ; Gross debridement for diseased patients
- Keywords
- Periodontal disease, Gum disease, Dental, Inflammation, Microorganisms, Bacteria
- Medical subject headings
- Periodontal Diseases, Gingival Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylaxis ; Gross debridement for diseased patientsProcedure or surgery
Also called Teeth cleaning
1 per patient at 2nd visit lasting approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Patients with severe periodontal disease Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients
Other Names:
Teeth cleaning
1 per patient at 2nd visit lasting approximately 1 hour. Receives: Procedure: Prophylaxis ; Gross debridement for diseased patients | |
| Healthy patients | Patients without periodontal (gum) disease Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients
Other Names:
Teeth cleaning Receives: Procedure: Prophylaxis ; Gross debridement for diseased patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify microorganism components in the serum of patients with severe periodontitis
microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning
Measured: 1hour
Secondary outcomes (1)
Characterize the immune regulator activity of periodontitis serum
microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Giannobile, University of Michigan
- Investigators
- William V Giannobile, DDS, DMedSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154855
- Sponsor's protocol ID
- HUM00029568
- Acronym
- CirCo
- Status last verified
- Dec 2015
- First submitted
- 16 Mar 2010
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Akira S, Uematsu S, Takeuchi O. Pathogen recognition and innate immunity. Cell. 2006 Feb 24;124(4):783-801. doi: 10.1016/j.cell.2006.02.015.
PubMed 16497588Forner L, Nielsen CH, Bendtzen K, Larsen T, Holmstrup P. Increased plasma levels of IL-6 in bacteremic periodontis patients after scaling. J Clin Periodontol. 2006 Oct;33(10):724-9. doi: 10.1111/j.1600-051X.2006.00964.x. Epub 2006 Aug 10.
PubMed 16901299D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. doi: 10.1177/154405910408300214.
PubMed 14742655Garlet GP, Martins W Jr, Ferreira BR, Milanezi CM, Silva JS. Patterns of chemokines and chemokine receptors expression in different forms of human periodontal disease. J Periodontal Res. 2003 Apr;38(2):210-7. doi: 10.1034/j.1600-0765.2003.02012.x.
PubMed 12608917Pussinen PJ, Paju S, Mantyla P, Sorsa T. Serum microbial- and host-derived markers of periodontal diseases: a review. Curr Med Chem. 2007;14(22):2402-12. doi: 10.2174/092986707781745604.
PubMed 17896988Marchesan J, Jiao Y, Schaff RA, Hao J, Morelli T, Kinney JS, Gerow E, Sheridan R, Rodrigues V, Paster BJ, Inohara N, Giannobile WV. TLR4, NOD1 and NOD2 mediate immune recognition of putative newly identified periodontal pathogens. Mol Oral Microbiol. 2016 Jun;31(3):243-258. doi: 10.1111/omi.12116. Epub 2015 Sep 10.
PubMed 26177212
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulatory Microbial Components and Immune Regulators of Patients With Periodontal Disease and Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01154855
- Acronym / sponsor ID
- CirCo / HUM00029568
- Conditions
- Periodontal Disease
- Keywords
- Periodontal disease, Gum disease, Dental, Inflammation, Microorganisms, Bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Jul 2010 (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 goal of this project is to study the immune activity of certain proteins present in the blood of patients with severe periodontal disease. Periodontal disease (gum disease) is the major cause of tooth loss among adults. Moderate to severe periodontal disease is reported to affect 5-15% of American adults. It begins with an infection of the tissues surrounding the teeth, and leads to a worsening inflammatory response. This study will aid in clarifying the way in which gum disease might affect certain systemic diseases.
Detailed description
This project will have two specific goals: 1. Identify microorganism components in the serum of patients with severe periodontitis; and 2. Characterize the immune regulator activity of periodontitis serum. This proposed feasibility study will then aid in providing the support for an increased sample size and other design requirements for larger, more expanded human clinical trial testing.In this study, forty (40) subjects will be divided into 2 groups: 1) Healthy oral status group and 2) Severe periodontal disease. Patients will be clinically screened using standard periodontal measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | Procedure: Prophylaxis ; Gross debridement for diseased patientsPatients with severe periodontal disease Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients Other Names: Teeth cleaning 1 per patient at 2nd visit lasting approximately 1 hour. |
| Healthy patients | – | Procedure: Prophylaxis ; Gross debridement for diseased patientsPatients without periodontal (gum) disease Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients Other Names: Teeth cleaning |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 adult subjects comprised of two populations: 1) healthy (n=20) and 2) severe periodontal disease (n=20)
Key inclusion criteria (4 listed)
- 35 years or older
- Healthy patients or patients with severe periodontal disease
- Patients with or without Rheumatoid Arthritis
- Patients with at least 20 permanent teeth
Key exclusion criteria (6 listed)
- Patients undergoing long-term (over 2 weeks) antibiotic-related therapy 3 months prior to study inclusion
- Patients receiving periodontal treatment 12 months prior to study inclusion (INCLUDING CLEANINGS)
- Patients will be excluded if they receive long-term use of medications known to affect periodontal status such as anti-inflammatory drugs, aspirin and ibuprofen
- Patients on immunosuppressive therapies, including glucocorticoids or cyclosporines, are excluded from participation in this study (inhalers are allowed)
- History of metabolic bone diseases such as rheumatoid arthritis or post-menopausal osteoporosis
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 |
|---|---|---|
| Prophylaxis ; Gross debridement for diseased patientsAlso: Teeth cleaning1 per patient at 2nd visit lasting approximately 1 hour. | Procedure or surgery | Healthy patients, Periodontitis |
Primary outcome
Identify microorganism components in the serum of patients with severe periodontitis
Time frame: 1hour
microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning
1 secondary outcome
Characterize the immune regulator activity of periodontitis serum
Time frame: 1 hour
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 14 Dec 2015.
- Background: PubMed 16497588Akira S, Uematsu S, Takeuchi O. Pathogen recognition and innate immunity. Cell. 2006 Feb 24;124(4):783-801. doi: 10.1016/j.cell.2006.02.015.
- Background: PubMed 16901299Forner L, Nielsen CH, Bendtzen K, Larsen T, Holmstrup P. Increased plasma levels of IL-6 in bacteremic periodontis patients after scaling. J Clin Periodontol. 2006 Oct;33(10):724-9. doi: 10.1111/j.1600-051X.2006.00964.x. Epub 2006 Aug 10.
- Background: PubMed 14742655D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. doi: 10.1177/154405910408300214.
- Background: PubMed 12608917Garlet GP, Martins W Jr, Ferreira BR, Milanezi CM, Silva JS. Patterns of chemokines and chemokine receptors expression in different forms of human periodontal disease. J Periodontal Res. 2003 Apr;38(2):210-7. doi: 10.1034/j.1600-0765.2003.02012.x.
- Background: PubMed 17896988Pussinen PJ, Paju S, Mantyla P, Sorsa T. Serum microbial- and host-derived markers of periodontal diseases: a review. Curr Med Chem. 2007;14(22):2402-12. doi: 10.2174/092986707781745604.
- Results publication: PubMed 26177212Marchesan J, Jiao Y, Schaff RA, Hao J, Morelli T, Kinney JS, Gerow E, Sheridan R, Rodrigues V, Paster BJ, Inohara N, Giannobile WV. TLR4, NOD1 and NOD2 mediate immune recognition of putative newly identified periodontal pathogens. Mol Oral Microbiol. 2016 Jun;31(3):243-258. doi: 10.1111/omi.12116. Epub 2015 Sep 10.
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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.
William V Giannobile, DDS, DMedSc principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease, run by University of Michigan.
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 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 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Identify microorganism components in the serum of patients with severe periodontitis (time frame: 1hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154855, which also lists 6 linked publications.
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 14 Dec 2015; AzTrials last refreshed its copy on 31 Oct 2026.