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NCT Number: NCT07099378

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

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.

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Key information

Conditions

Periodontal Diseases Inflammation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Fatih, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Saliva and Serum

Other

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.

Primary outcomes

  1. 1. Pocket probing depth

    Time frame: 6 months

    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.

  2. 2.Clinical attachment level

    Time frame: 6 months

    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)

  3. 3.Bleeding on probing

    Time frame: 6 months

    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.

Secondary outcomes

  1. 4.Saliva and serum samples processing and analyses

    Time frame: 1 month

    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).

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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