Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT06627192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-30
First Post:
2024-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-α Levels in GCF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-28', 'size': 342876, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-28T04:29', 'hasProtocol': True}, {'date': '2024-10-28', 'size': 162990, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-28T04:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure measurement', 'timeFrame': '3 months', 'description': 'Measure Systolic and dyastolic Blood pressure at baseline and at followup'}], 'primaryOutcomes': [{'measure': 'Clinical assessment of PI plaque index', 'timeFrame': '3 months', 'description': '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.\n\nPlaque index at deepest pocket will be measured.'}, {'measure': 'Clinical assessment of BOP bleeding on probing', 'timeFrame': '3 months', 'description': '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.\n\nbleeding on probing at deepest pocket will be measured'}, {'measure': 'Clinical assessment of CAL clinical attachment loss', 'timeFrame': '3 months', 'description': '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.\n\nclinical attachment loss at deepest pocket will be recorded.'}, {'measure': 'Clinical assessment of PD probing depth', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Biochemical assesment of Endocan', 'timeFrame': '3 months', 'description': 'Using GCF samples and asses Endocan by ELISA kit'}, {'measure': 'Biochemical assesment of TNF-α', 'timeFrame': '3 months', 'description': 'Using GCF samples and asses TNF-α by ELISA kit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peridontitis', 'Stage 2', 'Hypertension', 'Pro-inflammatory cytokines', 'GCF', 'NSPT', 'ELISA', 'Endocan', 'ESM-1', 'Biochemical assessment', 'Non-surgical periodontal therapy'], 'conditions': ['Periodontitis', 'Hypertension', 'TNF Alpha', 'Endocan', 'GCF']}, 'descriptionModule': {'briefSummary': '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.\n\nAim 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.', 'detailedDescription': "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.\n\nStudy procedures:\n\nDetails of the interventions, testing and follow up:\n\nGroup Case (I):\n\nThis 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.\n\nGroup Control (II):\n\nThis 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.\n\nStudy protocol and surgical steps:\n\nBefore 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.\n\nFor all patients who are suitable for the study the following clinical evaluation parameters will be measured:\n\nPlaque index (PI) Gingival index (GI) Probing depth (PD) Bleeding on probing (BOP) Clinical attachment level (CAL) Standardized periapical radiograph.\n\nNote: Full mouth assessment will be done and then the deepest site will be evaluated for the GCF sample.\n\nBaseline GCF samples will be taken the day after patients were clinically evaluated to prevent contamination with blood related to the probing of inflamed areas.\n\nThe 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.\n\nAll patients will undergo full mouth NSPT, this will be done using ultrasonic and hand instruments.\n\nThe 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.\n\nTwo 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.\n\nThen clinical evaluation, collection of samples and measuring of SBP and DBP will be performed at 3 months after NSPT in both groups.\n\nThe Outcomes Assessment:\n\nClinical assessment. Biochemical assessment. Blood pressure measurement.\n\nFor 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.\n\nClinical Assessment The following clinical parameters will be taken using UNC15 Probe at baseline and 3 months postoperative.\n\nPlaque index:\n\n* no plaque.\n* plaque recognized only by running a probe across the tooth surface.\n* plaque visible to the naked eye.\n* abundance of soft matter.\n\nGingival index:\n\n* Normal gingiva\n* Mild inflammation - slight edema. No bleeding on probing\n* Moderate inflammation -redness, edema and glazing. Bleeding on probing.\n* Severe inflammation - marked redness and edema. Ulceration. Tendency for spontaneous bleeding\n\nProbing depth :\n\nWill 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.\n\nClinical attachment level (CAL):Will be measured from the CEJ to the depth of the periodontal pocket.\n\nb) Biochemical Assessment:\n\nBiochemical 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.\n\nc) Blood Pressure measurement: Systolic and diastolic Blood pressure measurement will be done according to, 2020 International Society of Hypertension Global Hypertension Practice Guidelines.\n\nIX. Statistical Analysis The obtained results will be collected, tabulated, and subjected to appropriate statistical analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).\n\nBoth 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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n* Both genders aged from 30-70.\n* Minimum 20 natural teeth excluding third molars.\n* Good compliance with the plaque control instructions following initial therapy.\n* Availability for follow-up and maintenance program.\n\nExclusion Criteria:\n\n* Smokers.\n* Pregnant and lactating females.\n* Patients with other systemic diseases, such as diabetes mellitus, rheumatoid arthritis and cancer.\n\n(According to Cornell Medical Index-Health Questionnaire).\n\n* Patients taking antibiotic, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of the trial and during the study.\n* Patients who have undergone any periodontal therapy in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT06627192', 'briefTitle': 'Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-α Levels in GCF', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-a Levels in Gingival Crevicular Fluid (Case Control Study)', 'orgStudyIdInfo': {'id': 'FDASU-RECD 1293 1123 1234'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 Case', 'description': 'Group Case (I):\n\nThis 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.', 'interventionNames': ['Procedure: NSPT, clinical and biochemical assesment']}, {'label': 'Group 2 Control', 'description': '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.', 'interventionNames': ['Procedure: NSPT, clinical and biochemical assesment']}], 'interventions': [{'name': 'NSPT, clinical and biochemical assesment', 'type': 'PROCEDURE', 'otherNames': ['ELISA kit for GCF sample test'], 'description': 'Biochemical assessment using ELISA kit for Endcan and TNF alpha GCF sample', 'armGroupLabels': ['Group 1 Case', 'Group 2 Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's candidate", 'investigatorFullName': 'Lana Nabil', 'investigatorAffiliation': 'Ain Shams University'}}}}