Diagnostic Potential of the Salivary Biomarkers to Differentiate Statuses of Periodontitis

Diagnostic Potential of the Salivary (miRNAs - 146-a, 186, IL-1ß, and IL- 10) to Differentiate Statuses of Periodontitis: A Case-Control Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq
    • University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

2. 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

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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
(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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis	The primary outcomes will be determining salivary levels of (miRNAs 146-a, 186, IL-1β, and IL-10	base line

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: periodontitis; saliva; case control
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 527622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No