Periodontal Status and TMAO Levels in Peripheral Artery Disease

NCT07449546 | Completed

• 1 other identifier: 36290600/15/2022
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate the association between periodontal status and trimethylamine-N-oxide (TMAO) levels in patients diagnosed with peripheral artery disease (PAD). Both serum and saliva TMAO concentrations will be measured and compared according to periodontal health, periodontitis, and edentulism status. Clinical periodontal examinations and biological sample collection will be performed. The study seeks to investigate whether oral health status is associated with systemic TMAO levels in individuals with PAD.

Conditions

Periodontal Diseases; Edentulism; Peripheral Arterial Disease

Keywords

Trimethylamine-N-oxide; Periodontal Disease; Edentulism; Peripheral Arterial Disease; Saliva; Serum

Outcome Measures

Primary Outcomes (2)

• Serum Trimethylamine-N-Oxide (TMAO) Levels (ng/ml)

  Comparison of serum TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism).

  At baseline (single time-point assessment)

• Salivary Trimethylamine-N-oxide (TMAO) Level (ng/ml)

  Comparison of salivary TMAO concentrations according to periodontal status (periodontitis, gingivitis, and edentulism).

  At baseline (single time-point assessment)

Secondary Outcomes (5)

• Mean Periodontal Probing Depth (mm)

  At baseline

• Mean Clinical Attachment Loss (mm)

  At baseline

• Bleeding on Probing (%)

  At baseline

• Plaque Index (mean score)

  At baseline

• Number of Remaining Teeth

  At baseline

Other Outcomes (11)

• Duration of Active Smoking (in years)

  At baseline

• Number of Cigarettes Smoked per Day (Cigarettes/day)

  At baseline

• Duration Since Smoking Cessation (in years)

  At baseline

Study Arms (3)

gingivitis

Patients diagnosed with gingivitis

periodontitis

Patients diagnosed with periodontitis

edentulism

Patients diagnosed with edentulism according to severe periodontitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with confirmed peripheral arterial disease (PAD) who were referred for vascular evaluation were enrolled in this cross-sectional observational study. Participants had intact limbs and were categorized according to their periodontal status as periodontitis, gingivitis, or edentulous (with self-reported history of tooth loss due to advanced periodontitis). All participants met the predefined inclusion and exclusion criteria prior to enrollment.

You may qualify if:

• Adults aged ≥18 years
• Confirmed diagnosis of Peripheral Arterial Disease (PAD), defined as: Ankle-Brachial Index (ABI) \< 0.9 and/or angiographic or ultrasonographic evidence of arterial stenosis
• No limb amputation
• Presence of teeth and willingness to undergo full-mouth periodontal examination
• Edentulous status with self-reported history of complete tooth loss due to advanced periodontitis
• Ability to provide informed consent

You may not qualify if:

• Pregnant individuals
• Use of oral contraceptives
• Systemic antibiotic use within the previous 3 months
• Corticosteroid use within the previous 3 months
• Immunosuppressive therapy within the previous 3 months
• Chronic non-steroidal anti-inflammatory drug (NSAID) use within the previous 3 months
• Active periodontal treatment within the previous 6 months
• Periodontal surgery within the previous 1 year

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood (serum) and unstimulated saliva samples were collected and stored for biochemical analysis of trimethylamine-N-oxide (TMAO) levels. No DNA extraction was performed.

MeSH Terms

Conditions

Periodontal Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Şivge Kurgan, DDS, PhD

  Ankara University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 4, 2026
• Study Start: February 15, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 15, 2024
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data will be available beginning 6 months after publication of the primary results and will remain available for 5 years upon reasonable request. Supporting documents including the study protocol and statistical analysis plan will also be available during this period. Access will be granted following institutional approval and in accordance with ethical regulations.
• Access Criteria: Access to de-identified individual participant data will be granted to qualified researchers upon submission of a methodologically sound research proposal. Requests will be reviewed by the principal investigator and the institutional review authority. Data will be shared following approval and execution of a data use agreement, in accordance with ethical and institutional regulations.

Locations

TU (1)