Diagnostic Potential of the Salivary Biomarkers to Differentiate Statuses of Periodontitis

NCT05722613 | Unknown

• 1 other identifier: 527622
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Keywords

periodontitis; saliva; case control

Outcome Measures

Primary Outcomes (1)

• diagnosis

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

  base line

Study Arms (3)

(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)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male and female systemically healthy patients.
• Body mass index ≤ 30.
• Have a minimum of 20 teeth with facial and lingual scorable surfaces.
• Clinical criteria for periodontal health and periodontitis will be as follows :
• \. Healthy periodontium (Group A): BOP \<10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss).
• \. 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

You may not qualify if:

• Patients who refused to participate in the study.
• Individuals with dental implants.
• Previous history of extensive periodontal therapy preceding 6 months or currently under active periodontal treatment.
• Patients receiving antibiotic treatment or immunosuppressant medication within the last 3 months
• Pregnant or lactating mothers.
• Any symptoms of recent acute illness, e.g., COVID-19.
• Tobacco use.
• Active orthodontic therapy

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad

Baghdad, Iraq

Location

Related Publications (1)

• 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.

  PMID: 39445112 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• zainab J Raheem, MSc

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal invstigator

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

IR (1)