Clinical trial NCT05663476: NSPT On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease
Official title: Effect Of Non Surgical Therapy On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease- An Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Periodontitis
Cardiovascular Diseases
Periodontal Inflammation
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm clinical trial
Primary purpose: TREATMENT

Brief summary: Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signalling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with a multiple binding domain that interacts with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that is involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, an another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis and mineralization throughout the body. The study aims to determine the expression of Vitronectin and Fetuin-A as potential pro-inflammatory and anti-inflammatory biomarkers respectively. These protein molecules can further play a role as putative risk indicators in periodontitis subjects with and without coronary artery disease following non-surgical therapy.

Detailed description: Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signaling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with multiple binding domains that interact with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that are involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis, and mineralization throughout the body. To find out the effect of non-surgical therapy on the periodontal and cardiac parameters and the salivary levels of Vitronectin and Fetuin-A in patients with periodontitis (stage II-III) and coronary artery disease.

Eligibility criteria: Inclusion Criteria:

1. Patients willing to participate in the study.
2. Patients within the age group of 30-65 years (male)
3. Patients should have ≥ 10 remaining natural teeth.
4. No history of long term antibiotic use in past 6 months.

Exclusion Criteria:

1. Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation.
2. Chronic treatment (\>2 weeks) with drugs known to affect periodontal tissues (phenytoin or cyclosporin).
3. Female patients were excluded due to hormonal variations.
4. For Group II and III, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
5. Current smokers and individuals who quit smoking less than 6 months.
6. Patients who have undergone periodontal therapy within the previous 6 months.

Primary outcomes:
measure: Reduction in periodontal parameters
timeFrame: Two years
measure: Reduction in periodontal variables
timeFrame: Two years
measure: Reduction in periodontal criteria
timeFrame: Two years
measure: Reduction in periodontal variables
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Meenakshi Ammal Dental College and Hospital
state: Tamil NADU
Study officials:
References: