Diagnostic Potential of the Salivary Biomarkers to Differentiate Statuses of Periodontitis

NCT ID: NCT05722613

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-06-01

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

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

Conditions

Periodontitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

(Group A) periodontally healthy as a control

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

No interventions assigned to this group

(Group B) periodontitis currently unstable

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

No interventions assigned to this group

(Group C)periodontitis currently stable .

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

No interventions assigned to this group

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Zainab Jalil Raheem

principal invstigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zainab J Raheem, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

University of Baghdad

Baghdad, , Iraq

Countries

Iraq

References

Raheem ZJ, Abdulbaqi HR. Diagnostic Potential of Salivary Interleukin-1beta and IL-10 for Distinguishing Periodontal Health From Periodontitis and Stable From Unstable Periodontitis: A Case-Control Study. Int J Dent. 2024 Oct 15;2024:8006278. doi: 10.1155/2024/8006278. eCollection 2024.

Reference Type: DERIVED

PMID: 39445112 (View on PubMed)

Other Identifiers

527622

Identifier Type: -

Identifier Source: org_study_id