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Trial record 2 of 7 for:    gum disease | Recruiting Studies | NIH

Genomic Determinants and Shared Genetic Pathways of Periodontal Disease

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ClinicalTrials.gov Identifier: NCT03437798
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Tufts University

Tracking Information
First Submitted Date January 2, 2018
First Posted Date February 19, 2018
Last Update Posted Date September 14, 2018
Actual Study Start Date January 30, 2018
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2018)
  • Validity of self-reported periodontal disease [ Time Frame: Dental records will be requested retrospectively around the time of questionnaire turned-in that self-reported periodontal disease was reported. The record will be traced back 2 years and prospectively 1 years at the date of report (total 3 years) ]
    Cronbach's alpha correlation coefficients will be calculated
  • Correlation of CDC-AAP periodontal condition questions vs. periodontal disease diagnosis [ Time Frame: Dental records will be requested retrospectively (3 years) for participants who will return 2018 annual follow-up questionnaire with CDC-AAP questions ]
    Correlation coefficients will be calculated
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03437798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genomic Determinants and Shared Genetic Pathways of Periodontal Disease
Official Title Exploring Genomic Determinants of Periodontal Disease Via Shared Genetic Pathways With Cardiovascular Disease, Diabetes, and Bone Density
Brief Summary Despite significant improvement in treating periodontal disease (PD) and the identification of multiple risk factors, little is known about the specific contribution of genetics to PD pathogenesis. Several genomewide association studies (GWAS) of PD have been published, but only one reported locus has reached the threshold for genome-wide significance. Epidemiological studies and biological experiments established associations and suggested common pathogenetic pathways between PD and cardiovascular disease (CVD), diabetes (DM), and osteoporosis. The overall objective is to identify genetic loci for PD as a first step toward a better understanding of PD pathogenesis. In a preliminary study in the Women's Genome Health Study (WGHS), new-onset cases of PD were associated with a family history of myocardial infarction (MI). Further preliminary analyses presented shared phenotypic variation of PD/CVD, PD/DM, or PD/osteoporosis that could be accounted by the whole-genome genetic matrices. Several variants from the GWAS catalog of bone density and family history of MI were found correlated with PD in the WGHS. Based on these findings and the literature, the central hypothesis is that there are common pathogenetic links between PD and these other diseases and that GWAS using the comorbidity case definitions will help identify potential common loci.
Detailed Description

Three specific aims are proposed to refine and validate the PD status in the Women's Health Study (WHS/WGHS) to improve the phenotypic characterization of GWAS of PD: (1) Addition of CDC-AAP (Centers for Disease Control - American Academy of Periodontology) periodontal disease instrument to the WHS annual follow-up survey. (2) Validate existing Periodontal Disease (PD) status in the WHS/WGHS (subset). Request of dental records for 180 women sampled from the WHS who had reported diagnosis of PD in the past. (3) Correlation and validation analysis of new periodontal disease information with requested dental record (most recently dated). Phone interviews and request of dental records for 180 women sampled from the WHS/WGHS who visited a dentist within recent 36 months.

In addition, the investigators propose to identify genetic determinants of PD shared with CVD, DM, or osteoporosis via an integrative computational biological networks approach. Although the systemic links between PD vs. DM, CVD or osteoporosis have been established in clinical genetics as well as in experimental models, high-throughput investigations for gene-gene interplays between the associated conditions (CVD vs. PD; DM vs. PD; osteoporosis vs. PD) have not been explored yet. The investigators propose to approach this using an integrative in silico method, combining existing diverse biological information including genomic, epigenetic, expression and protein data. To our knowledge, this is the first time that hierarchical levels of integrative precision medicine will be tested for PD vs. CVD/DM/osteoporosis to generate plausible hypotheses and experimental targets.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The participants in this protocol are women in the Women's Health Study that agreed to be contacted for follow-up after the clinical trial ended in 2004~2005.
Condition
  • Periodontal Diseases
  • Diabetes
  • Osteoporosis
  • Cardiovascular Risk Factor
Intervention Other: Disease status
Women who reported periodontal disease diagnosis/condition
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 12, 2018)
360
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women who are willing to consent for requesting dental records;
  • Outcome 1 - Women who reported periodontal disease diagnosis at any time point up to the 2006 follow up;
  • Outcome 1 - Women whose dental records will be retrievable and usable (retrospectively 2 years and prospectively 1 year at the time of report of periodontal disease diagnosis)
  • Outcome 2 - Women who are willing to complete and turn-in the WHS 2018 Annual Follow-up Questionnaire with CDC-AAP oral health questions
  • Outcome 2 - Women whose dental records will be retrievable and usable (retrospectively 3 years at the time of 2018 Annual Follow-up Questionnaire turn-in)
  • The definition of usable dental records consist of but not exclusive to clinical note, complete periodontal charting, and full-mouth radiographs series (FMX) or panoramic, bite-wing radiographs that could derive a PD diagnosis based on the American Academy of Periodontology 1999 definitions.

Exclusion Criteria:

- Women whose dental records are not retrievable or incomplete.

Sex/Gender
Sexes Eligible for Study: Female
Ages 45 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yau-Hua Yu, DDS, DMSc 617-636-6659 ext 1 yau-hua.yu@tufts.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03437798
Other Study ID Numbers HH1804
1K23DE026804-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tufts University
Study Sponsor Tufts University
Collaborators
  • Brigham and Women's Hospital
  • National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Study Director: Kathleen Benoit Tufts University
Principal Investigator: Yau-Hua Yu, DDS, DMSc Tufts University School of Dental Medicine
PRS Account Tufts University
Verification Date September 2018