Periodontal Diseases InflammationNCT07099378
Micro Ribonucleic Acid (miRNA) Expression and Inflammatory Factors in Patients With Parkinson's and Periodontal Disease
A study testing Saliva and Serum in people with Periodontal Diseases Inflammation, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases Inflammation
- What is being tested?
- Saliva and Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- diagnosis of rheumatoid arthritis
- pregnancy
- lactating
- smoking
- excessive alcohol consumption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Relationship Between 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.
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.
- Conditions
- Periodontal Diseases Inflammation
- Being tested
- Saliva and Serum
- Keywords
- periodontal disease miRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva and SerumOther
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 SerumOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Collection of patients' saliva and serum and analysis of sample molecules. Receives: 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). Receives: Other: Saliva and Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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)
Measured: 6 months
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.
Measured: 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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Diseases InflammationStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis Yilmaz, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099378
- Sponsor's protocol ID
- 106
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Micro Ribonucleic Acid (miRNA) Expression and Inflammatory Factors in Patients With Parkinson's and Periodontal Disease
- ClinicalTrials.gov ID
- NCT07099378
- Acronym / sponsor ID
- 106
- Conditions
- Periodontal Diseases Inflammation
- Keywords
- periodontal disease miRNA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: Saliva and SerumCollection of patients' saliva and serum and analysis of sample molecules. |
| Experimental | Experimental | Other: Saliva and SerumELISA 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- dentally and periodontally healthy
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva and SerumSaliva 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. | Other | Active Comparator |
| Saliva and SerumELISA 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 | Experimental |
Primary outcome
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.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.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.
1 secondary outcome
4.Saliva and serum samples processing and analyses
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva and Serum in people with Periodontal Diseases Inflammation, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Pocket probing depth (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.