About this trial
There is a strong crossway relationship between periodontitis and hypertension. Hypertension is the most prevalent of cardiovascular diseases and its prevalence is increased by the presence of periodontitis. Periodontal attachment loss is higher in hypertension patients when compared to healthy subjects. Both are examples of non-communicable diseases (NCDs), also known as chronic inflammatory diseases, they tend to be of long duration and are the result of a combination of genetic, physiological and environmental factors. The lack of an appropriate balance between these factors results in cellular changes as well as the levels of cytokines with subsequent changes in clinical manifestations of periodontal diseases. Both periodontitis and hypertension are associated with inflammation and an increase in specific proinflammatory cytokines.
Aim of the study: To investigate the correlation between the clinical parameters and the levels of Endocan and TNF-α in gingival crevicular fluid (GCF) before and after non-surgical periodontal therapy (NSPT) in stage II periodontitis patients with hypertension in comparison to non-hypertensive patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with stage II periodontitis and controlled hypertension (self-reported history of a diagnosis of HTN by a physician and blood pressure (SBP < 140 and DBP < 90).
Both genders aged from 30-70.
Minimum 20 natural teeth excluding third molars.
Good compliance with the plaque control instructions following initial therapy.
Disqualifiers
Smokers.
Pregnant and lactating females.
Patients with other systemic diseases, such as diabetes mellitus, rheumatoid arthritis and cancer.
Patients taking antibiotic, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of the trial and during the study.
Trial population
Patients with stage II periodontitis and controlled hypertension (self-reported history of a diagnosis of HTN by a physician and blood pressure (SBP \< 140 and DBP \< 90). Both genders aged from 30-70. Minimum 20 natural teeth excluding third molars. Good compliance with the plaque control instructions following initial therapy. Availability for follow-up and maintenance program.
Trial design
Case-control
Prospective
Treatments tested in this trial
NSPT, clinical and biochemical assesment
Procedure/SurgeryBiochemical assessment using ELISA kit for Endcan and TNF alpha GCF sample
Treatment groups
Trial outcomes
Primary outcomes
Clinical assessment of PI plaque index
For clinical assessment the following clinical parameter PI plaque index will be recorded for each individual at 1 site at baseline and 3 months postoperatively. Clinical parameters of PI will be assessed at 2 weeks, 4 weeks and 6 weeks follow ups to ensure proper oral hygiene. Regarding biochemical analysis, GCF samples will be collected preoperative and 3 months after NSPT. Plaque index at deepest pocket will be measured.
Clinical assessment of BOP bleeding on probing
For clinical assessment the following clinical parameter BOP will be recorded for each individual at 1 site at baseline and 3 months postoperatively. Clinical parameters of BOP will be assessed at 2 weeks, 4 weeks and 6 weeks follow ups to ensure proper oral hygiene. Regarding biochemical analysis, GCF samples will be collected preoperative and 3 months after NSPT. bleeding on probing at deepest pocket will be measured
Clinical assessment of CAL clinical attachment loss
For clinical assessment the following clinical parameter CAL will be recorded.for each individual at 1 site at baseline and 3 months postoperatively. Regarding biochemical analysis, GCF samples will be collected preoperative and 3 months after NSPT. clinical attachment loss at deepest pocket will be recorded.
Clinical assessment of PD probing depth
For clinical assessment the following clinical parameter PD will be recorded for each individual at 1 site at baseline and 3 months postoperatively. Regarding biochemical analysis, GCF samples will be collected preoperative and 3 months after NSPT. PD at deepest pocket will be recorded.
Secondary outcomes
Biochemical assesment of Endocan
Using GCF samples and asses Endocan by ELISA kit
Biochemical assesment of TNF-α
Using GCF samples and asses TNF-α by ELISA kit
Other outcomes
Blood pressure measurement
Measure Systolic and dyastolic Blood pressure at baseline and at followup
Locations
Sponsors and contacts
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