Periodontal DiseasesNCT03437798
Genomic Determinants and Shared Genetic Pathways of Periodontal Disease
An observational study of Periodontal Diseases and Diabetes, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 100 years, women only
- Conditions the study is for
- Periodontal Diseases, Diabetes, Osteoporosis
- What is being tested?
- Disease status
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 31 Dec 2023
- 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 45 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Women whose dental records are not retrievable or incomplete.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: Exploring Genomic Determinants of Periodontal Disease Via Shared Genetic Pathways With Cardiovascular Disease, Diabetes, and Bone Density
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.
Read the 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.
- Being tested
- Disease status
- Keywords
- Periodontal Disease, Diabetes, Osteoporosis, Cardiovascular Risk Factor, Genomic
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease statusOther
Women who reported periodontal disease diagnosis/condition
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of self-reported periodontal disease
Cronbach's alpha correlation coefficients will be calculated
Measured: 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)
Correlation of CDC-AAP periodontal condition questions vs. periodontal disease diagnosis
Correlation coefficients will be calculated
Measured: Dental records will be requested retrospectively (3 years) for participants who will return 2018 annual follow-up questionnaire with CDC-AAP questions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start30 Jan 2018
- Primary completion31 May 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Yau-Hua Yu, Tufts University
- Investigators
- Kathleen Benoit, Study director, Tufts UniversityYau-Hua Yu, DDS, DMSc, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437798
- Sponsor's protocol ID
- HH1804
- Other IDs
- 1K23DE026804-01
- Status last verified
- Apr 2024
- First submitted
- 2 Jan 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu YH, Doucette-Stamm L, Rogus J, Moss K, Zee RYL, Steffensen B, Ridker PM, Buring JE, Offenbacher S, Kornman K, Chasman DI. Family History of MI, Smoking, and Risk of Periodontal Disease. J Dent Res. 2018 Sep;97(10):1106-1113. doi: 10.1177/0022034518782189. Epub 2018 Jun 21.
PubMed 29928831Shungin D, Haworth S, Divaris K, Agler CS, Kamatani Y, Keun Lee M, Grinde K, Hindy G, Alaraudanjoki V, Pesonen P, Teumer A, Holtfreter B, Sakaue S, Hirata J, Yu YH, Ridker PM, Giulianini F, Chasman DI, Magnusson PKE, Sudo T, Okada Y, Volker U, Kocher T, Anttonen V, Laitala ML, Orho-Melander M, Sofer T, Shaffer JR, Vieira A, Marazita ML, Kubo M, Furuichi Y, North KE, Offenbacher S, Ingelsson E, Franks PW, Timpson NJ, Johansson I. Genome-wide analysis of dental caries and periodontitis combining clinical and self-reported data. Nat Commun. 2019 Jun 24;10(1):2773. doi: 10.1038/s41467-019-10630-1.
PubMed 31235808
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Genomic Determinants of Periodontal Disease Via Shared Genetic Pathways With Cardiovascular Disease, Diabetes, and Bone Density
- ClinicalTrials.gov ID
- NCT03437798
- Acronym / sponsor ID
- HH1804
- Keywords
- Periodontal Disease, Diabetes, Osteoporosis, Cardiovascular Risk Factor, Genomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Women whose dental records are not retrievable or incomplete.
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 |
|---|---|---|
| Disease statusWomen who reported periodontal disease diagnosis/condition | Other | – |
Primary outcome
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
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 11 Apr 2024.
- Results publication: PubMed 29928831Yu YH, Doucette-Stamm L, Rogus J, Moss K, Zee RYL, Steffensen B, Ridker PM, Buring JE, Offenbacher S, Kornman K, Chasman DI. Family History of MI, Smoking, and Risk of Periodontal Disease. J Dent Res. 2018 Sep;97(10):1106-1113. doi: 10.1177/0022034518782189. Epub 2018 Jun 21.
- Results publication: PubMed 31235808Shungin D, Haworth S, Divaris K, Agler CS, Kamatani Y, Keun Lee M, Grinde K, Hindy G, Alaraudanjoki V, Pesonen P, Teumer A, Holtfreter B, Sakaue S, Hirata J, Yu YH, Ridker PM, Giulianini F, Chasman DI, Magnusson PKE, Sudo T, Okada Y, Volker U, Kocher T, Anttonen V, Laitala ML, Orho-Melander M, Sofer T, Shaffer JR, Vieira A, Marazita ML, Kubo M, Furuichi Y, North KE, Offenbacher S, Ingelsson E, Franks PW, Timpson NJ, Johansson I. Genome-wide analysis of dental caries and periodontitis combining clinical and self-reported data. Nat Commun. 2019 Jun 24;10(1):2773. doi: 10.1038/s41467-019-10630-1.
- Individual participant dataSharing planned: No
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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.
Kathleen Benoit study director
Tufts University
Yau-Hua Yu, DDS, DMSc principal investigator
Tufts University School of Dental Medicine
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 Periodontal Diseases and Diabetes, run by Tufts University 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 6 inclusion and 1 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 11 Apr 2024. 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?
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)). The study lists 2 primary outcomes in all. 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 NCT03437798, which also lists 2 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 11 Apr 2024.