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Status unknownNCT05722613Updated Feb 10, 2023

Diagnostic Potential of the Salivary Biomarkers to Differentiate Statuses of Periodontitis

An observational study in Periodontitis, sponsored by University of Baghdad. Status unknown at 1 site in Iraq. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by University of Baghdad · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 85 Years
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Periodontitis

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Keywords

  • periodontitis
  • saliva
  • case control
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In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 120 is above the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Baghdad is the lead sponsor of 164 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The patients will be recruited from the Department of Periodontics, College of Dentistry, University of Baghdad.

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 :
  1. Healthy periodontium (Group A): BOP \<10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss).
  1. 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

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

    -

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • (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)

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What researchers measure

Primary outcomes

  1. diagnosis

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

    Time frame: base line

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Study locations

1 site
  • University of Baghdad
    Baghdad, Iraq
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05722613
Lead sponsor
University of Baghdad
Responsible party
Zainab Jalil Raheem (principal invstigator, University of Baghdad) — Principal investigator
First posted
Feb 10, 2023
Start date
May 1, 2022
Primary completion
Apr 1, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Feb 10, 2023

Study contacts

zainab J Raheem, MSc
principal investigator · University of Baghdad

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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