Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-α Levels in GCF

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-70
SponsorAin Shams University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • NSPT, clinical and biochemical assesment

    Procedure/Surgery

    Biochemical assessment using ELISA kit for Endcan and TNF alpha GCF sample

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1 Case1 intervention
Group B: Group 2 Control1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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

Time frame
3 months
3

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.

Time frame
3 months
4

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.

Time frame
3 months

Secondary outcomes

1

Biochemical assesment of Endocan

Using GCF samples and asses Endocan by ELISA kit

Time frame
3 months
2

Biochemical assesment of TNF-α

Using GCF samples and asses TNF-α by ELISA kit

Time frame
3 months

Other outcomes

1

Blood pressure measurement

Measure Systolic and dyastolic Blood pressure at baseline and at followup

Time frame
3 months

Locations

This trial has no locations.

Sponsors and contacts

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