Development of Inflammatory Disease Model Protein, Genetic and Microbial Biomarkers

NCT00980525 | Completed

• 1 other identifier: 2009-02
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Healthy

Keywords

healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  35 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (6)

• 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.

  PMID: 14158464 BACKGROUND

• 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.

  PMID: 41862 BACKGROUND

• 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.

  PMID: 9526927 BACKGROUND

• 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.

  PMID: 3856578 BACKGROUND

• 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.

  PMID: 11518250 BACKGROUND

• 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.

  PMID: 21563952 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plaque, saliva, and intraoral specimens

Study Officials

• Janet Kinney, RDH, MS, MS

  University of Michigan, Department of Periodontics and Oral Medicine

  PRINCIPAL INVESTIGATOR

• William V Giannobile, DDS, DMed Sc

  University of Michigan Center for Oral Health Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)