Diagnostic Potential of the Salivary Biomarkers to Differentiate Statuses of Periodontitis

Sponsor
University of Baghdad (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05722613
Collaborator
(none)
120
1
13
9.2

Study Details

Study Description

Brief Summary

Periodontitis is a chronic inflammatory disease characterized by both dysbiosis of oral microbiota and proinflammatory events involving both cells and mediators from innate and adaptive immunity. These events lead to chronic inflammation of periodontal soft and hard tissues sharing many features with other chronic inflammatory diseases. These events lead to chronic inflammation of periodontal soft and hard tissues sharing many features with other chronic inflammatory diseases. Chronic inflammation is driven by various mediators, of which a significant part is attributed to the interactions within cytokine networks. While proinflammatory cytokines, including interleukin (IL) -1α, IL-1β, TNF-α, IL-6, and IL-17, contribute to acute and chronic inflammation and tissue injury, a second group with antagonist effects is formed by cytokines such as IL-10

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Diagnosis of Periodontitis represents the backbone of a successful periodontal treatment since the entire treatment plan, prognosis, and maintenance directly depend on the quality and precision of periodontal diagnosis. Since periodontal diagnostics is still based on clinical and radiological parameters providing limited therapeutic guidance, biomarkers have been introduced for the first time within the new classification of periodontal and peri-implant conditions as a first step towards the adoption of precision medicine concepts in periodontology. Saliva, as part of oral fluids, is an optimal biological fluid that contains locally and systemically derived mediators of periodontal disease (proteins, genetic/genomic biomarkers such as DNA and mRNA, and various metabolites that originate from the host and the bacteria) to serve as the diagnostic tool for periodontitis. The collection of saliva is safe, non-invasive, and simple, and saliva can be collected repeatedly with minimum discomfort to the patient. Single biomarker detection may not be effective enough for accurate diagnoses without false-positive or false-negative results. Periodontitis is a disease that involves complex interactions between bacteria and the host immune system. The combination of the host and bacteria-derived biomarkers, which reflect inflammation, soft tissue destruction, and bone destruction together, may be helpful in the diagnosis

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic Potential of the Salivary (miRNAs - 146-a, 186, IL-1ß, and IL- 10) to Differentiate Statuses of Periodontitis: A Case-Control Study
    Actual Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    (Group A) periodontally healthy as a control

    BOP <10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss).

    (Group B) periodontitis currently unstable

    Generalized periodontitis, currently unstable (PPD ≥ 5mm or PPD at ≥ 4mm with BOP).

    (Group C)periodontitis currently stable .

    Generalized periodontitis, currently stable (BOP < 10 % PPD ≤4 mm and no BOP at 4mm sites)

    Outcome Measures

    Primary Outcome Measures

    1. diagnosis [base line]

      The primary outcomes will be determining salivary levels of (miRNAs 146-a, 186, IL-1β, and IL-10

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Male and female systemically healthy patients.

    2. Body mass index ≤ 30.

    3. Have a minimum of 20 teeth with facial and lingual scorable surfaces.

    4. Clinical criteria for periodontal health and periodontitis will be as follows :

    5. Healthy periodontium (Group A): BOP <10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss).

    6. Periodontitis groups are defined as : i. Interdental CAL is detectable at ≥2 non-adjacent teeth, or ii. Buccal or oral CAL ≥3 mm with pocketing >3mm is detectable at ≥2teeth

    Exclusion Criteria:
    1. Patients who refused to participate in the study.

    2. Individuals with dental implants.

    3. Previous history of extensive periodontal therapy preceding 6 months or currently under active periodontal treatment.

    4. Patients receiving antibiotic treatment or immunosuppressant medication within the last 3 months

    5. Pregnant or lactating mothers.

    6. Any symptoms of recent acute illness, e.g., COVID-19.

    7. Tobacco use.

    8. Active orthodontic therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Baghdad Baghdad Iraq

    Sponsors and Collaborators

    • University of Baghdad

    Investigators

    • Principal Investigator: zainab J Raheem, MSc, University of Baghdad

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zainab Jalil Raheem, principal invstigator, University of Baghdad
    ClinicalTrials.gov Identifier:
    NCT05722613
    Other Study ID Numbers:
    • 527622
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zainab Jalil Raheem, principal invstigator, University of Baghdad
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 10, 2023