NCT07272564

Brief Summary

Parkinson's disease is a slowly progressing disease that affects the motor and non-motor functions of an individual. Periodontitis is an inflammatory chronic disease resulting in the destruction of tooth supporting structures. Inflammation has been identified as an important factor in both diseases. Given this common mechanism, the question arises as to how they may affect each other when both diseases occur together. In this study, we compared the metabolism of tryptophan, a natural amino acid of the human body, and observed whether such a process provides a biological link between periodontitis and Parkinson's disease. We extracted the saliva and blood samples of patients of Parkinson's disease and periodontitis, patients of periodontitis and healthy human beings. Comparisons between the three were made, and it was found that levels of some metabolites of tryptophan were higher in the patients of both diseases. These findings raise the possibility of a close biological connection between periodontal and brain health. Through an increased understanding of this connection in the future, new approaches for diagnosis and treatment of Parkinson's disease and periodontitis may be developed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

periodontal diseaseTryptophanKynurenine

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

Saliva and serum collection of patients and samples molecules analysis

Other: Saliva and serum sampling

Experimental

EXPERIMENTAL

Samples were analyzed for TRP, KYN, KYN/TRP ratio, KYNA, 3OHKYN, picolinic acid (PA), and quinolinic acid (QA) by liquid chromatography-mass spectrometry. Clinical periodontal parameters \[plaque index (PI), probing pocket depth (PPD), clinical attachment loss (CAL), and bleeding on probing (BOP)\] were recorded.

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

Active Comparator

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.

Experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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

MeSH Terms

Conditions

Periodontal DiseasesInflammation

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Saliva and serum samples were collected from periodontitis patients and with Parkinson's +periodontitis patients. Samples were analyzed for TRP, KYN, KYN/TRP ratio, KYNA, 3OHKYN, picolinic acid (PA), and quinolinic acid (QA) by liquid chromatography-mass spectrometry.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof Dr

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

May 15, 2022

Primary Completion

January 10, 2023

Study Completion

June 18, 2023

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations