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

NCT06627192 | Not Yet Recruiting

• 1 other identifier: FDASU-RECD 1293 1123 1234
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontitis; Hypertension; TNF Alpha; Endocan; GCF

Keywords

Peridontitis; Stage 2; Hypertension; Pro-inflammatory cytokines; GCF; NSPT; ELISA; Endocan; ESM-1; Biochemical assessment; Non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (4)

• 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.

  3 months

• 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

  3 months

• 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.

  3 months

• 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.

  3 months

Secondary Outcomes (2)

• Biochemical assesment of Endocan

  3 months

• Biochemical assesment of TNF-α

  3 months

Other Outcomes (1)

• Blood pressure measurement

  3 months

Study Arms (2)

Group 1 Case

Group Case (I): This group will include 20 patients diagnosed with stage II periodontitis and controlled hypertension. They will receive NSPT and oral hygiene measures will be instructed following treatment.

Procedure: NSPT, clinical and biochemical assesment

Group 2 Control

This group will include 20 patients diagnosed with stage II periodontitis and no hypertension. They will receive NSPT and oral hygiene measures will be instructed following treatment.

Procedure: NSPT, clinical and biochemical assesment

Interventions

NSPT, clinical and biochemical assesment PROCEDURE

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

Also known as: ELISA kit for GCF sample test

Group 1 Case; Group 2 Control

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Smokers.
• Pregnant and lactating females.
• Patients with other systemic diseases, such as diabetes mellitus, rheumatoid arthritis and cancer.
• (According to Cornell Medical Index-Health Questionnaire).
• Patients taking antibiotic, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of the trial and during the study.
• Patients who have undergone any periodontal therapy in the last 6 months.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Periodontitis; Hypertension

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's candidate

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: October 4, 2024
• Study Start: March 10, 2025
• Primary Completion: October 30, 2025
• Study Completion: January 30, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01