Development of Inflammatory Disease Model Protein, Genetic and Microbial Biomarkers
NCT ID: NCT00980525
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2009-05-31
2010-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Janet Kinney
Associate Clinical Professor
Principal Investigators
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Janet Kinney, RDH, MS, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan, Department of Periodontics and Oral Medicine
William V Giannobile, DDS, DMed Sc
Role: STUDY_DIRECTOR
University of Michigan Center for Oral Health Research
Locations
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University of Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States
Countries
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References
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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.
Loesche 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.
Oliver 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.
Listgarten 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.
Kornman 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.
Lee 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.
Related Links
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University of Michigan Clinical Research Database homepage
Other Identifiers
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2009-02
Identifier Type: -
Identifier Source: org_study_id