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Not yet recruitingNCT07099378Updated Aug 1, 2025

Micro Ribonucleic Acid (miRNA) Expression and Inflammatory Factors in Patients With Parkinson's and Periodontal Disease

An interventional study of Saliva and Serum and Saliva and Serum in Periodontal Diseases Inflammation, sponsored by Medipol University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by Medipol University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

MicroRNAs are important regulators of the immune and inflammatory response to bacterial pathogens during periodontal disease.The aim of this study was to evaluate the possible miRNA type for Parkinson's in saliva of orally healthy individuals.

Read the detailed description

A total of 51 individuals, 35 systemically healthy and 16 with Parkinson's disease and both dental and periodontal health, were included in the study.Clinical periodontal parameters, DMFT data and salivary flow rates were recorded.Unstimulated saliva samples were taken from each participant and miRNA was evaluated by RT-qPCR method.ELISA method was used to measure TNF α values in collected saliva and serum samples.

02

Conditions studied

  • Periodontal Diseases Inflammation

Keywords

  • periodontal disease miRNA
03

In context

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • dentally and periodontally healthy

    • Systemically healthy with no uncontrolled chronic and/or autoimmune disease
    • No systemic, neurological, or autoimmune disease in addition to Parkinson's disease.

Exclusion criteria

Exclusion Criteria:

  • 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\<20 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Active comparator
    Active Comparator

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

    Other: Saliva and Serum

  • Experimental
    Experimental

    ELISA method will be used to measure TNF-α values in collected saliva and serum samples.RT-qPCR based miRNA gene expression analyses will be performed with 2-step qRT-PCR Kits (Thermofisher Scientific, MA, USA).

    Other: Saliva and Serum

Interventions

  • OtherSaliva and Serum

    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 10 mL of blood samples were collected by qualified staff from each participant.Saliva and serum were then stored at -80 °C until analysis.

  • OtherSaliva and Serum

    ELISA method will be used to measure TNF-α values in collected saliva and serum samples.RT-qPCR based miRNA gene expression analyses will be performed with 2-step qRT-PCR Kits (Thermofisher Scientific, MA, USA).

06

What researchers measure

Primary outcomes

  1. 1. 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.

    Time frame: 6 months

  2. 2.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)

    Time frame: 6 months

  3. 3.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.

    Time frame: 6 months

Secondary outcomes

  1. 4.Saliva and serum samples processing and analyses

    ELISA method will be used to measure TNF-α values in collected saliva and serum samples.RT-qPCR based miRNA gene expression analyses will be performed with 2-step qRT-PCR Kits (Thermofisher Scientific, MA, USA).

    Time frame: 1 month

07

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, Fatih, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07099378
Lead sponsor
Medipol University
Responsible party
Melis Yilmaz (Assistant Prof Dr, Medipol University) — Principal investigator
First posted
Aug 1, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Aug 1, 2025

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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