HealthyNCT00980525
Development of Inflammatory Disease Model Protein, Genetic and Microbial Biomarkers
An observational study of Healthy, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine if certain levels of proteins lead to inflammation of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This protein is found at higher levels in areas of inflammation. This type of study is called an experimental gingivitis study. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Apr 2010
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will involve two groups: 15 subjects who are IL-1 genotype positive and 15 subjects who are IL-1 genotype negative. Potential participants will be recruited at the University of Michigan. A screening process will be performed by the study personnel to all potential participants to determine eligibility according to the inclusion and exclusion criteria. The prevalence of IL-1 genotype positive patients has been shown to be related to the patients' ethnic group. In Caucasians, the prevalence was found to be approximately 34% in non smokers. On the other hand, only about 2.3% of Asians and 26% of Hispanics were found to be IL-1 genotype positive. In order to limit ethnic variations, subjects in our study will be limited only to Caucasians.
Who may be able to join
- Caucasian subjects between 18-40 years of age (throughout the study)
- Dentition with a minimum of 20 permanent teeth
- Mean score of less than or equal to 1 for plaque index, gingival index and papillary bleeding
- Compliance with all requirements in the study and signing the informed consent
Who cannot join
- Current smokers, smokers who quit less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette-packs smoked per day)
- Antibiotic therapy within 3 months of baseline or the need for antibiotics for infective endocarditis prophylaxis or other conditions
- Chronic medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications…)
- Pregnancy or lactating mothers
- Combined score of greater than 1 for plaque index, gingival index, and papillary bleeding at the screening visit
- Current orthodontic or periodontal treatments
Show all 11Show fewer
- History of alcoholism or drug abuse
- Untreated carious lesions or defective restorations which could exacerbate during a period of oral hygiene abstinence
- Diseases of the immune system or any medical condition that may influence the outcome (diabetes, neurologic or psychiatric disorders, systemic infections…)
- New oral contraceptives users within 3 months of baseline or those planning on starting oral contraceptives during the study
- Depo-Provera contraceptive injection users
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
The purpose of this study is to determine if certain levels of proteins lead to inflammation of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This protein is found at higher levels in areas of inflammation. This type of study is called an experimental gingivitis study. It will involve stopping your routine oral health care for 21 days. If you qualify, you will receive a full dental cleaning at the beginning and end of the study. Approximately 30 patients will participate in this study at the Michigan Center for Oral Health Research (MCOHR).
Read the detailed description
Gingivitis is a specific oral infectious disease that affects approximately 50% of the adult population on an average of 3 to 4 teeth. Although dental plaque is the primary etiology of most periodontal diseases, patients are not equally susceptible and do not respond similarly to professional care. Therefore, assessing the future risk of patients for developing gingivitis with possible subsequent progression to chronic periodontitis may help the clinician in elaborating a more accurate and suitable treatment plan for the patients and a better assessment of their prognoses. In fact, the prevention of plaque-induced gingivitis is still considered the first step in the maintenance of periodontal health.
Experimental gingivitis has been used widely to study the microbiology and the events that occur in the transition from a state of gingival health to inflammation. In a classical study by Löe and Theilade, periodontally healthy subjects were asked to cease all forms of oral hygiene for 3-4 weeks.
Studies of the levels of proinflammatory biomarkers have been of increased interest for the past decades. Since changes in the levels of these salivary biomarkers occur prior to clinical signs of gingivitis, their measurements may provide a more objective, earlier and accurate assessment of gingival inflammatory changes compared to the traditional bleeding and plaque indices.
Despite the clinical significance of gingivitis, little is know about the correlation between the levels of salivary biomarkers, the presence of periodontal pathogens and IL-1 polymorphism, and how this affect their susceptibility to gingivitis. If IL-1 polymorphism is indeed associated with increased levels of pro-inflammatory cytokines expression and the presence of specific periodontal pathogens, then screening for this polymorphism will be a valuable and necessary tool. As periodontal treatments, such as scaling and root planing, have been shown to be successful at decreasing the levels of IL-1 in the gingival crevicular fluid, a more aggressive treatment regimen may be warranted when the patient is genotype positive. If biomarkers in saliva and plaque biofilm can serve as accurate predictors of gingivitis, the ability for early detection of disease in patients is enhanced. Pro-inflammatory salivary biomarkers, specific pathogenic bacteria and genotype aid in establishing more accurate diagnostic and prognostic parameters of periodontal diseases, compared to current parameters (e.g. probing pocket depth, clinical attachment loss...) that reflect the history rather than the present and future status of disease. As a consequence, intervention can be initiated prior to irreversible tissue breakdown and oral health care costs may be reduced. Research efforts in the future should be directed toward the establishment of an affordable and practical chairside salivary test.
- Conditions
- Healthy
- Keywords
- healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IL-1 genotype positive | There are three known IL-1 genes arranged in a cluster on human chromosome 2q13. Although the clinical application is still debatable, polymorphism in the IL-1 gene cluster was found to be associated with increased susceptibility to periodontal diseases. Conflicting studies demonstrate that a possible relationship between IL-1 genotype and clinical parameters of gingivitis may exist.This study will involve 15 subjects who are genotype positive and 15 subjects who are genotype negative. | |
| IL-1 genotype negative | There are three known IL-1 genes arranged in a cluster on human chromosome 2q13. Although the clinical application is still debatable, polymorphism in the IL-1 gene cluster was found to be associated with increased susceptibility to periodontal diseases. Conflicting studies demonstrate that a possible relationship between IL-1 genotype and clinical parameters of gingivitis may exist.This study will involve 15 subjects who are genotype positive and 15 subjects who are genotype negative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to better understand the relationship between salivary proinflammatory biomarkers of gingivitis, the presence of specific bacteria and IL-1 polymorphism through experimental gingivitis.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionApr 2010
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 HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Kinney, University of Michigan
- Investigators
- Janet Kinney, RDH, MS, MS, Principal investigator, University of Michigan, Department of Periodontics and Oral MedicineWilliam V Giannobile, DDS, DMed Sc, Study director, University of Michigan Center for Oral Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980525
- Sponsor's protocol ID
- 2009-02
- Status last verified
- Dec 2015
- First submitted
- 18 Sep 2009
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464Loesche WJ. Clinical and microbiological aspects of chemotherapeutic agents used according to the specific plaque hypothesis. J Dent Res. 1979 Dec;58(12):2404-12. doi: 10.1177/00220345790580120905.
PubMed 41862Oliver RC, Brown LJ, Loe H. Periodontal diseases in the United States population. J Periodontol. 1998 Feb;69(2):269-78. doi: 10.1902/jop.1998.69.2.269.
PubMed 9526927Listgarten MA, Schifter CC, Laster L. 3-year longitudinal study of the periodontal status of an adult population with gingivitis. J Clin Periodontol. 1985 Mar;12(3):225-38. doi: 10.1111/j.1600-051x.1985.tb00920.x.
PubMed 3856578Kornman KS. Patients are not equally susceptible to periodontitis: does this change dental practice and the dental curriculum? J Dent Educ. 2001 Aug;65(8):777-84.
PubMed 11518250Lee A, Ghaname CB, Braun TM, Sugai JV, Teles RP, Loesche WJ, Kornman KS, Giannobile WV, Kinney JS. Bacterial and salivary biomarkers predict the gingival inflammatory profile. J Periodontol. 2012 Jan;83(1):79-89. doi: 10.1902/jop.2011.110060. Epub 2011 May 12.
PubMed 21563952
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Inflammatory Disease Model Protein, Genetic and Microbial Biomarkers
- ClinicalTrials.gov ID
- NCT00980525
- Acronym / sponsor ID
- 2009-02
- Conditions
- Healthy
- Keywords
- healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Sep 2009 (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 if certain levels of proteins lead to inflammation of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This protein is found at higher levels in areas of inflammation. This type of study is called an experimental gingivitis study. It will involve stopping your routine oral health care for 21 days. If you qualify, you will receive a full dental cleaning at the beginning and end of the study. Approximately 30 patients will participate in this study at the Michigan Center for Oral Health Research (MCOHR).
Detailed description
Gingivitis is a specific oral infectious disease that affects approximately 50% of the adult population on an average of 3 to 4 teeth. Although dental plaque is the primary etiology of most periodontal diseases, patients are not equally susceptible and do not respond similarly to professional care. Therefore, assessing the future risk of patients for developing gingivitis with possible subsequent progression to chronic periodontitis may help the clinician in elaborating a more accurate and suitable treatment plan for the patients and a better assessment of their prognoses. In fact, the prevention of plaque-induced gingivitis is still considered the first step in the maintenance of periodontal health.
Experimental gingivitis has been used widely to study the microbiology and the events that occur in the transition from a state of gingival health to inflammation. In a classical study by Löe and Theilade, periodontally healthy subjects were asked to cease all forms of oral hygiene for 3-4 weeks.
Studies of the levels of proinflammatory biomarkers have been of increased interest for the past decades. Since changes in the levels of these salivary biomarkers occur prior to clinical signs of gingivitis, their measurements may provide a more objective, earlier and accurate assessment of gingival inflammatory changes compared to the traditional bleeding and plaque indices.
Despite the clinical significance of gingivitis, little is know about the correlation between the levels of salivary biomarkers, the presence of periodontal pathogens and IL-1 polymorphism, and how this affect their susceptibility to gingivitis. If IL-1 polymorphism is indeed associated with increased levels of pro-inflammatory cytokines expression and the presence of specific periodontal pathogens, then screening for this polymorphism will be a valuable and necessary tool. As periodontal treatments, such as scaling and root planing, have been shown to be successful at decreasing the levels of IL-1 in the gingival crevicular fluid, a more aggressive treatment regimen may be warranted when the patient is genotype positive. If biomarkers in saliva and plaque biofilm can serve as accurate predictors of gingivitis, the ability for early detection of disease in patients is enhanced. Pro-inflammatory salivary biomarkers, specific pathogenic bacteria and genotype aid in establishing more accurate diagnostic and prognostic parameters of periodontal diseases, compared to current parameters (e.g. probing pocket depth, clinical attachment loss...) that reflect the history rather than the present and future status of disease. As a consequence, intervention can be initiated prior to irreversible tissue breakdown and oral health care costs may be reduced. Research efforts in the future should be directed toward the establishment of an affordable and practical chairside salivary test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-1 genotype positive | – | –There are three known IL-1 genes arranged in a cluster on human chromosome 2q13. Although the clinical application is still debatable, polymorphism in the IL-1 gene cluster was found to be associated with increased susceptibility to periodontal diseases. Conflicting studies demonstrate that a possible relationship between IL-1 genotype and clinical parameters of gingivitis may exist.This study will involve 15 subjects who are genotype positive and 15 subjects who are genotype negative. |
| IL-1 genotype negative | – | –There are three known IL-1 genes arranged in a cluster on human chromosome 2q13. Although the clinical application is still debatable, polymorphism in the IL-1 gene cluster was found to be associated with increased susceptibility to periodontal diseases. Conflicting studies demonstrate that a possible relationship between IL-1 genotype and clinical parameters of gingivitis may exist.This study will involve 15 subjects who are genotype positive and 15 subjects who are genotype negative. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will involve two groups: 15 subjects who are IL-1 genotype positive and 15 subjects who are IL-1 genotype negative. Potential participants will be recruited at the University of Michigan. A screening process will be performed by the study personnel to all potential participants to determine eligibility according to the inclusion and exclusion criteria. The prevalence of IL-1 genotype positive patients has been shown to be related to the patients' ethnic group. In Caucasians, the prevalence was found to be approximately 34% in non smokers. On the other hand, only about 2.3% of Asians and 26% of Hispanics were found to be IL-1 genotype positive. In order to limit ethnic variations, subjects in our study will be limited only to Caucasians.
Key inclusion criteria (4 listed)
- Caucasian subjects between 18-40 years of age (throughout the study)
- Dentition with a minimum of 20 permanent teeth
- Mean score of less than or equal to 1 for plaque index, gingival index and papillary bleeding
- Compliance with all requirements in the study and signing the informed consent
Key exclusion criteria (11 listed)
- Current smokers, smokers who quit less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette-packs smoked per day)
- Antibiotic therapy within 3 months of baseline or the need for antibiotics for infective endocarditis prophylaxis or other conditions
- Chronic medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications…)
- Pregnancy or lactating mothers
- Combined score of greater than 1 for plaque index, gingival index, and papillary bleeding at the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The aim of this study is to better understand the relationship between salivary proinflammatory biomarkers of gingivitis, the presence of specific bacteria and IL-1 polymorphism through experimental gingivitis.
Time frame: 35 days
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 3 Dec 2015.
- Background: PubMed 14158464SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
- Background: PubMed 41862Loesche WJ. Clinical and microbiological aspects of chemotherapeutic agents used according to the specific plaque hypothesis. J Dent Res. 1979 Dec;58(12):2404-12. doi: 10.1177/00220345790580120905.
- Background: PubMed 9526927Oliver RC, Brown LJ, Loe H. Periodontal diseases in the United States population. J Periodontol. 1998 Feb;69(2):269-78. doi: 10.1902/jop.1998.69.2.269.
- Background: PubMed 3856578Listgarten MA, Schifter CC, Laster L. 3-year longitudinal study of the periodontal status of an adult population with gingivitis. J Clin Periodontol. 1985 Mar;12(3):225-38. doi: 10.1111/j.1600-051x.1985.tb00920.x.
- Background: PubMed 11518250Kornman KS. Patients are not equally susceptible to periodontitis: does this change dental practice and the dental curriculum? J Dent Educ. 2001 Aug;65(8):777-84.
- Derived from this study: PubMed 21563952Lee A, Ghaname CB, Braun TM, Sugai JV, Teles RP, Loesche WJ, Kornman KS, Giannobile WV, Kinney JS. Bacterial and salivary biomarkers predict the gingival inflammatory profile. J Periodontol. 2012 Jan;83(1):79-89. doi: 10.1902/jop.2011.110060. Epub 2011 May 12.
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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.
Janet Kinney, RDH, MS, MS principal investigator
University of Michigan, Department of Periodontics and Oral Medicine
William V Giannobile, DDS, DMed Sc study director
University of Michigan Center for Oral Health Research
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 Healthy, run by University of Michigan 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 11 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 3 Dec 2015. 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?
The aim of this study is to better understand the relationship between salivary proinflammatory biomarkers of gingivitis, the presence of specific bacteria and IL-1 polymorphism through experimental gingivitis. (time frame: 35 days). 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 NCT00980525, 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 3 Dec 2015.