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To learn how gum disease and swelling in the mouth are connected to heart valve disease in people

Serum and salivary assessment of NT pro BNP and Trimethylamine N oxide in Valvular heart disease patients with and without Periodontal Disease - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/105286
Enrollment
80
Registered
2026-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K053- Chronic periodontitis Health Condition 2: I359- Nonrheumatic aortic valve disorder, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Ojasvitaa H Menon
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy individuals. Based on the classification system introduced by Kornman and Tonetti et al 2018.Pristine periodontal health. No bleeding on probing. Normal gingival sulcus depth. Normal bone heights. Controlled modifying factors. Controlled predisposing factors. Clinical periodontal health: Intact periodontium, no or minimal bleeding on probing. Normal gingival sulcus depth. Normal bone heights. Controlled modifying factors. Controlled predisposing factors. Inclusion criteria for Stage III/IV Periodontitis. Periodontal diagnosis follows the 2018 Classification of Periodontal and Peri-implant Diseases using standardised clinical and radiographic parameters. Staging III IV is based on a composite assessment of probing depth, clinical attachment loss, bleeding on probing, and radiographic bone loss, consistent with Tonetti et al. Grading was omitted as it is intended for longitudinal assessment and does not affect the evaluation of current inflammatory burden or biomarker associations. Based on the classification system introduced by Kornman and Tonetti et al 2018. Stage III Interdental clinical attachment loss at the site of greatest loss greater than equal to 5mm. Radiographic bone loss extending to middle or apical third of root. Tooth loss due to periodontitis less than or equal to 4 teeth. Probing depth greater than or equal to 6mm. Extent: Greater than 30 percent of teeth involved (Generalized) Stage IV Interdental clinical attachment loss at site of greatest loss greater than 5mm.Radiographic bone loss extending to middle or apical third of root. Tooth loss due to periodontitis is greater than or equal to 5 teeth. Extent Greater than 30 percent of teeth involved. Inclusion criteria for valvular heart disease patients: Patients diagnosed with acquired, non-rheumatic, non-congenital valvular heart disease including Degenerative Aortic stenosis , Degenerative aortic regurgitation, Degenerative mitral regurgitation, Non-rheumatic calcific mitral stenosis and functional tricuspid regurgitation. Patients were classified according to the 2020 American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Individuals with Stage C (asymptomatic severe valvular heart disease), defined by severe valvular pathology on echocardiography with preserved (C1) or decompensated ventricular function (C2), and those with Stage D (symptomatic severe valvular heart disease) presenting with symptoms such as dyspnoea, fatigue, or reduced exercise tolerance were included.

Exclusion criteria

Exclusion criteria: Patients with a history of valvular surgery or cardiac intervention in the last six months. Patients with other systemic inflammatory conditions like sepsis, pneumonia, active infective endocarditis, pleural effusion, intra abdominal infections, inflammatory bowel disorders, inflammatory rheumatoid disorders, chronic kidney disease, diabetes, cancers, COPD, asthma, HIV and hepatitis and those who were pregnant will be excluded from the study Individuals with a history of tobacco or alcohol abuse were also excluded. History of periodontal treatment within the last 6 months. History of long term systemic corticosteroids, immunosuppressive, recent antibiotic therapy within last 3 months Subjects who are not willing to participate in the study.

Design outcomes

Primary

MeasureTime frame
To evaluate the ability of NT-pro BNP and TMAO as a potentional common serum and salivary biomarker for stage 3 and 4 periodontitis and risk of developing Valvular heart disease.Timepoint: Baseline

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDR OJASVITAA H MENON

SRM Dental College

priyankacholan@gmail.com9840771507

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026