Evaluation of the Effects of Levodopa-Benserazide Drug Combination on Periodontal Status in Patients With Parkinson's Disease

NCT07405268 | Active Not Recruiting DMC

• 1 other identifier: OSATAGUN4
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of Levodopa-Benserazide drug combination on periodontal status and salivary cytokine levels in patients with Parkinson's disease. The study includes four groups: Parkinson's patients with periodontitis, periodontally healthy Parkinson's patients, participants without Parkinson's with periodontitis, and periodontally healthy participants without Parkinson's. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Pocket Depth, and Clinical Attachment Loss) will be recorded. Unstimulated saliva samples will be collected to analyze the levels of TNF-alpha, RANTES, IL-10, IL-13, Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Malondialdehyde (MDA).

Conditions

Parkinson Disease (PD); Periodontitis; Periodontal Diseases

Keywords

Levodopa; Benserazide; Salivary Cytokines; Oxidative Stress; Inflammation

Outcome Measures

Primary Outcomes (7)

• Salivary Inflammatory Cytokine

  TNF-alpha,

  Day 1

• Salivary Inflammatory Cytokine

  RANTES

  Day 1

• Salivary Inflammatory Cytokine

  IL-10

  Day 1

• Salivary Inflammatory Cytokine

  IL-13

  Day 1

• Salivary Oxidative Stress Levels

  Total Oxidant Status (TOS)

  Day 1

• Salivary Oxidative Stress Levels

  Total Antioxidant Status (TAS)

  Day 1

• Salivary Oxidative Stress Levels

  Malondialdehyde (MDA)

  Day 1

Secondary Outcomes (5)

• Clinical Periodontal Parameters

  Day 1

• Clinical Periodontal Parameters

  Day 1

• Clinical Periodontal Parameters

  Day 1

• Clinical Periodontal Parameters

  Day 1

• Clinical Periodontal Parameters

  Day 1

Study Arms (4)

Parkinson's - Periodontitis

Patients diagnosed with Parkinson's Disease who also have Periodontitis.

Parkinson's - Healthy

Patients diagnosed with Parkinson's Disease who are periodontally healthy.

Control - Periodontitis

Systemically healthy participants (non-Parkinson) who have Periodontitis.

Control - Healthy

Systemically and periodontally healthy participants.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Department of Neurology at Hacettepe University Faculty of Medicine (Parkinson's patients) and the Department of Periodontology at the University of Health Sciences, Gulhane Faculty of Dentistry (Periodontitis patients and healthy controls).

You may qualify if:

• Diagnosis of Parkinson's Disease according to United Kingdom Parkinson's Disease Society Brain Bank Criteria (for study group).
• Systemically healthy individuals (for control group).
• Willingness to participate and sign informed consent.

You may not qualify if:

• Active smoking.
• Comprehensive periodontal treatment within the last month.
• Oral, respiratory, or digestive system diseases within the last 3 months.
• Fewer than 16 natural teeth.
• Use of full or removable partial dentures.
• Dementia or inability to provide consent.
• Serious active illnesses or substance abuse.
• Antibiotic treatment within the last 3 months.
• Probiotic use within the last month.
• Radiotherapy/chemotherapy within the last 6 months.
• Use of oral antiseptics within the last month.
• Diabetes mellitus.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Hacettepe University: collaborator

Study Sites (1)

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (3)

• Wei X, Gibiansky L, Wang Y, Fuh F, Erickson R, O'Byrne S, Tang MT. Pharmacokinetic and Pharmacodynamic Modeling of Serum Etrolizumab and Circulating beta7 Receptor Occupancy in Patients With Ulcerative Colitis. J Clin Pharmacol. 2018 Mar;58(3):386-398. doi: 10.1002/jcph.1031. Epub 2017 Nov 26.

  PMID: 29178491 RESULT

• Kononen E, Gursoy M, Gursoy UK. Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues. J Clin Med. 2019 Jul 31;8(8):1135. doi: 10.3390/jcm8081135.

  PMID: 31370168 RESULT

• Ye X, Chen J, Eric Irrgang M, Engel M, Dong A, Glotzer SC, Murray CB. Quasicrystalline nanocrystal superlattice with partial matching rules. Nat Mater. 2017 Feb;16(2):214-219. doi: 10.1038/nmat4759. Epub 2016 Sep 26.

  PMID: 27669053 RESULT

MeSH Terms

Conditions

Parkinson Disease; Periodontitis; Periodontal Diseases; Inflammation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 12, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TU (1)