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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Saliva and Serum

    Other intervention

    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.

  • Saliva and Serum

    Other intervention

    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).

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: Active ComparatorActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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