Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
NCT ID: NCT06582056
Last Updated: 2025-11-28
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
226 participants
INTERVENTIONAL
2024-10-09
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* To evaluate immune signatures in well-characterized populations with or without PD and/or T2DM
* To evaluate baseline clinical biomarkers of T2DM and PD in well-characterized populations
* To evaluate the influence of clinical, immunological, and microbiological biomarkers on the bidirectional relationship between T2DM and PD
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study
NCT05814965
Salivary Markers in Periodontal Disorders
NCT06576856
Biomarkers of Periodontal Disease Progression
NCT01489839
Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic
NCT02220751
SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
NCT03510702
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Investigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index \< 40 kg/m2
* Participants without type 2 diabetes mellitus (T2DM) or pre-diabetes (as confirmed by hemoglobin A1C (HbA1c) \< 5.7%) or Participants diagnosed with T2DM for at least 6 months with HbA1c between 6.5%-7.8% or 8%-10% on the day of screening
* Participants without PD (healthy or with gingivitis), or participants diagnosed with stages I/II or stages III/IV PD within 2 weeks of sample collection
Exclusion Criteria
* History of human immunodeficiency virus (HIV) infection, or active hepatitis B (HB) or hepatitis C virus infection
* Known or recently active (within 12 months) neoplastic disease (including skin cancer) or a current or past diagnosis of any hematologic malignancy (ie, leukemia)
* Participants with pre-existing unstable disease, defined as disease requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks prior to enrollment
* Active autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc)
* Known pregnancy (no pregnancy testing will be performed)
* Overt acute illness/infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[100.4°F\]) on the day of inclusion. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided for at least 2 consecutive days prior to enrollment
* Receipt of any vaccine within the 4 weeks preceding study enrollment
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months
* Current or recent (within 3 weeks of enrollment) receipt of systemic antibiotics
* Use of chlorhexidine mouthwash for \> 7 days within 3 weeks of enrollment
* Receipt of immunomodulators or immunosuppressive therapy, including long-term corticosteroid therapy
* Sub-gingival instrumentation/SRP within the 3 months prior to study enrollment
Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
30 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa - Site Number : 8400002
Iowa City, Iowa, United States
ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
Somerville, Massachusetts, United States
Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
Stony Brook, New York, United States
UT Health Houston School of Dentistry- Site Number : 8400003
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1306-7393
Identifier Type: REGISTRY
Identifier Source: secondary_id
VPE00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.