NCT07160894

Brief Summary

The host immune response to microorganisms is primarily recognized by pattern recognition receptors (PRRs), including toll-like receptors and nucleotide-binding oligomeric domain (NOD) receptors (NLRs). The aim of this study was to examine the relationship between periodontal disease and NOD in serum and saliva samples.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Expected
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 29, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

periodontal disease NOD

Outcome Measures

Primary Outcomes (3)

  • Pocket probing depth

    Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

    6 months

  • Clinical attachment level

    Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)

    6 months

  • Bleeding on probing

    Referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.

    6 months

Secondary Outcomes (1)

  • Saliva and serum samples processing and analyses

    1 month

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Collection of patients' saliva and serum and analysis of sample molecules.

Other: Saliva and Serum sampling

Experimental

EXPERIMENTAL

ELISA method will be used to evaluate NOD1 and NOD2, IL-10, IL-6 molecules in the saliva and serum samples obtained.

Other: Saliva and Serum sampling

Interventions

Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 5 mL of blood samples were collected by qualified staff from each participant.Saliva and serum were then stored at -80 °C until analysis.

Active ComparatorExperimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systemically healthy
  • clinical diagnosis of periodontal health
  • clinical diagnosis of periodontitis
  • clinical diagnosis of gingivitis

You may not qualify if:

  • history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
  • nonsurgical periodontal treatment (previous 6 months)
  • surgical periodontal treatment (previous 12 months)
  • presence of\<10 teeth
  • current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
  • diabetes
  • diagnosis of rheumatoid arthritis
  • pregnancy
  • lactating
  • smoking
  • excessive alcohol consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Saliva and serum of periodontitis patients collected for analyzing NOD1, NOD2, IL-10 and IL-6
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof Dr

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start

September 15, 2025

Primary Completion

March 12, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations