PeriodontitisNCT06627192
Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-α Levels in GCF
An observational study of Periodontitis and Hypertension, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Periodontitis, Hypertension, TNF Alpha
- What is being tested?
- NSPT, clinical and biochemical assesment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 30 Jan 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-a Levels in Gingival Crevicular Fluid (Case Control Study)
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.
Read the detailed description
Clinical assessment of specific clinical parameters: plaque index, gingival index, probing depth, clinical attachment level (CAL) as primary outcome. Biochemical assessment of Endocan and TNF-α levels in GCF by Enzyme Linked Immunosorbent Assay (ELISA) as well as measurement of blood pressure at baseline and after 3 months as secondary outcomes.
Study procedures:
Details of the interventions, testing and follow up:
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.
Group Control (II):
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.
Study protocol and surgical steps:
Before enrollment, a detailed case history will be recorded. A calibrated standard aneroid sphygmomanometer. The average of 3 blood pressure values (systolic blood pressure SBP and diastolic blood pressure DBP), will be taken at 1 minute interval, this will be used in data analyses.
For all patients who are suitable for the study the following clinical evaluation parameters will be measured:
Plaque index (PI) Gingival index (GI) Probing depth (PD) Bleeding on probing (BOP) Clinical attachment level (CAL) Standardized periapical radiograph.
Note: Full mouth assessment will be done and then the deepest site will be evaluated for the GCF sample.
Baseline GCF samples will be taken the day after patients were clinically evaluated to prevent contamination with blood related to the probing of inflamed areas.
The sample areas will be insulated with cotton rolls to prevent saliva contamination and all supragingival plaque will be eliminated. The paper strips will be placed into the periodontal pocket and then permitted to remain for 30 seconds.
All patients will undergo full mouth NSPT, this will be done using ultrasonic and hand instruments.
The patients will receive oral hygiene instructions including tooth brushing using modified bass technique. All patients will be provided with toothbrush (soft), toothpaste (signal) and interdental cleaning with dental floss or interdental brush.
Two weeks follow-up to ensure that appropriate oral hygiene instructions are followed. The clinical parameter to be assessed will be PI and BOP, patients with PI 2 and BOP > 10% will be eliminated from the study.
Then clinical evaluation, collection of samples and measuring of SBP and DBP will be performed at 3 months after NSPT in both groups.
The Outcomes Assessment:
Clinical assessment. Biochemical assessment. Blood pressure measurement.
For clinical assessment the following clinical parameters including PI, GI, PD, BOP and CAL will be recorded for each individual at 1 site at baseline and 3 months postoperatively. Clinical parameters of PI and 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. Blood pressure measurements will be taken before and after 3 months of NSPT.
Clinical Assessment The following clinical parameters will be taken using UNC15 Probe at baseline and 3 months postoperative.
Plaque index:
- no plaque.
- plaque recognized only by running a probe across the tooth surface.
- plaque visible to the naked eye.
- abundance of soft matter.
Gingival index:
- Normal gingiva
- Mild inflammation - slight edema. No bleeding on probing
- Moderate inflammation -redness, edema and glazing. Bleeding on probing.
- Severe inflammation - marked redness and edema. Ulceration. Tendency for spontaneous bleeding
Probing depth :
Will be measured from the gingival margin to the depth of the pocket at four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the nearest millimeter using UNC-15 periodontal probe. The average of the three facial points will be recorded as the facial probing depth (FPD) while the mid-lingual point will be recorded as the lingual probing depth.
Clinical attachment level (CAL):Will be measured from the CEJ to the depth of the periodontal pocket.
- Biochemical Assessment:
Biochemical assessment will be done at the deepest pocket at baseline and 3 months after non-surgical periodontal therapy. Endocan and TNF-α levels will be determined using commercial human Endocan (ESM-1) and TNF-α ELISA Kits. Measurements will be performed according to the manufacturer's instructions.
- Blood Pressure measurement: Systolic and diastolic Blood pressure measurement will be done according to, 2020 International Society of Hypertension Global Hypertension Practice Guidelines.
IX. Statistical Analysis The obtained results will be collected, tabulated, and subjected to appropriate statistical analysis.
- Conditions
- Periodontitis, Hypertension, TNF Alpha, Endocan, GCF
- Being tested
- NSPT, clinical and biochemical assesment
- Keywords
- Peridontitis, Stage 2, Hypertension, Pro-inflammatory cytokines, GCF, NSPT, ELISA, Endocan, ESM-1, Biochemical assessment, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSPT, clinical and biochemical assesmentProcedure or surgery
Also called ELISA kit for GCF sample test
Biochemical assessment using ELISA kit for Endcan and TNF alpha GCF sample
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: NSPT, clinical and biochemical assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
Biochemical assesment of Endocan
Using GCF samples and asses Endocan by ELISA kit
Measured: 3 months
Biochemical assesment of TNF-α
Using GCF samples and asses TNF-α by ELISA kit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start10 Mar 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lana Nabil, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627192
- Sponsor's protocol ID
- FDASU-RECD 1293 1123 1234
- Status last verified
- Jan 2025
- First submitted
- 26 Aug 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-a Levels in Gingival Crevicular Fluid (Case Control Study)
- ClinicalTrials.gov ID
- NCT06627192
- Acronym / sponsor ID
- FDASU-RECD 1293 1123 1234
- Conditions
- Periodontitis, Hypertension, TNF Alpha, Endocan, GCF
- Keywords
- Peridontitis, Stage 2, Hypertension, Pro-inflammatory cytokines, GCF, NSPT, ELISA, Endocan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clinical assessment of specific clinical parameters: plaque index, gingival index, probing depth, clinical attachment level (CAL) as primary outcome. Biochemical assessment of Endocan and TNF-α levels in GCF by Enzyme Linked Immunosorbent Assay (ELISA) as well as measurement of blood pressure at baseline and after 3 months as secondary outcomes.
Study procedures:
Details of the interventions, testing and follow up:
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.
Group Control (II):
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.
Study protocol and surgical steps:
Before enrollment, a detailed case history will be recorded. A calibrated standard aneroid sphygmomanometer. The average of 3 blood pressure values (systolic blood pressure SBP and diastolic blood pressure DBP), will be taken at 1 minute interval, this will be used in data analyses.
For all patients who are suitable for the study the following clinical evaluation parameters will be measured:
Plaque index (PI) Gingival index (GI) Probing depth (PD) Bleeding on probing (BOP) Clinical attachment level (CAL) Standardized periapical radiograph.
Note: Full mouth assessment will be done and then the deepest site will be evaluated for the GCF sample.
Baseline GCF samples will be taken the day after patients were clinically evaluated to prevent contamination with blood related to the probing of inflamed areas.
The sample areas will be insulated with cotton rolls to prevent saliva contamination and all supragingival plaque will be eliminated. The paper strips will be placed into the periodontal pocket and then permitted to remain for 30 seconds.
All patients will undergo full mouth NSPT, this will be done using ultrasonic and hand instruments.
The patients will receive oral hygiene instructions including tooth brushing using modified bass technique. All patients will be provided with toothbrush (soft), toothpaste (signal) and interdental cleaning with dental floss or interdental brush.
Two weeks follow-up to ensure that appropriate oral hygiene instructions are followed. The clinical parameter to be assessed will be PI and BOP, patients with PI 2 and BOP > 10% will be eliminated from the study.
Then clinical evaluation, collection of samples and measuring of SBP and DBP will be performed at 3 months after NSPT in both groups.
The Outcomes Assessment:
Clinical assessment. Biochemical assessment. Blood pressure measurement.
For clinical assessment the following clinical parameters including PI, GI, PD, BOP and CAL will be recorded for each individual at 1 site at baseline and 3 months postoperatively. Clinical parameters of PI and 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. Blood pressure measurements will be taken before and after 3 months of NSPT.
Clinical Assessment The following clinical parameters will be taken using UNC15 Probe at baseline and 3 months postoperative.
Plaque index:
- no plaque.
- plaque recognized only by running a probe across the tooth surface.
- plaque visible to the naked eye.
- abundance of soft matter.
Gingival index:
- Normal gingiva
- Mild inflammation - slight edema. No bleeding on probing
- Moderate inflammation -redness, edema and glazing. Bleeding on probing.
- Severe inflammation - marked redness and edema. Ulceration. Tendency for spontaneous bleeding
Probing depth :
Will be measured from the gingival margin to the depth of the pocket at four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the nearest millimeter using UNC-15 periodontal probe. The average of the three facial points will be recorded as the facial probing depth (FPD) while the mid-lingual point will be recorded as the lingual probing depth.
Clinical attachment level (CAL):Will be measured from the CEJ to the depth of the periodontal pocket.
- Biochemical Assessment:
Biochemical assessment will be done at the deepest pocket at baseline and 3 months after non-surgical periodontal therapy. Endocan and TNF-α levels will be determined using commercial human Endocan (ESM-1) and TNF-α ELISA Kits. Measurements will be performed according to the manufacturer's instructions.
- Blood Pressure measurement: Systolic and diastolic Blood pressure measurement will be done according to, 2020 International Society of Hypertension Global Hypertension Practice Guidelines.
IX. Statistical Analysis The obtained results will be collected, tabulated, and subjected to appropriate statistical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Case | – | Procedure: NSPT, clinical and biochemical assesmentGroup 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. |
| Group 2 Control | – | Procedure: NSPT, clinical and biochemical assesmentThis 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSPT, clinical and biochemical assesmentAlso: ELISA kit for GCF sample testBiochemical assessment using ELISA kit for Endcan and TNF alpha GCF sample | Procedure or surgery | Group 1 Case, Group 2 Control |
Primary outcome
Clinical assessment of PI plaque index
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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.
2 secondary outcomes
Biochemical assesment of Endocan
Time frame: 3 months
Biochemical assesment of TNF-α
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Hypertension, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of PI plaque index (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.