Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-31 @ 8:27 AM
Study NCT ID:
NCT05818657
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2021-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Apical Periodontitis With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006304', 'term': 'Health Status'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood analysis for CRP, Serum ferritin, Albumin, Creatinine \\& Urea'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2021-12-11', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periapical Index(PAI)', 'timeFrame': '1 year', 'description': 'Periodical status will be assessed in periodical radiograph and scoring of periapical index will be done according to size and periphery of peri-apical radiolucency with coding 1 to 5'}, {'measure': 'eGFR', 'timeFrame': '1 year', 'description': 'BY BLOOD SAMPLE measured in mL/min/1.73m2'}, {'measure': 'serum creatinine', 'timeFrame': '1 year', 'description': 'BY BLOOD SAMPLE measured in mg/dL'}, {'measure': 'hs-CRP', 'timeFrame': '1 year', 'description': 'HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L'}, {'measure': 'Blood urea', 'timeFrame': '1 year', 'description': 'measured by collecting blood sample in mg/dL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Apical Periodontitis', 'Root Canal Treatment'], 'conditions': ['Chronic Kidney Diseases', 'Periapical Lesions']}, 'descriptionModule': {'briefSummary': 'This investigation is aimed to assess the prevalence and severity of apical periodontitis (AP) in different stages of CKD patients and its impact on the systemic (nutritional and inflammatory) markers was compared to healthy individuals.', 'detailedDescription': '105 CKD patients (35 early (EG), 35pre-dialysis (PDG) and 35 hemodialysis (HDG)groups and 105 age and gender matched healthy controls were assessed for prevalence and severity of apical periodontitis and oral disease burden . Inflammatory (hsCRP and ferritin) and nutritional (urea and creatinine) markers were estimated and eGFR was calculated for the study population. Logistic regression was used to determine the possible association between CKD and AP in study population and Linear regression was performed to evaluate the possible association between systemic markers and endodontic burden (EB) in experimental group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CKD patients of different levels (Stage 1 to Stage 5) with age and gender matched controls will be enrolled in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known patient of CKD Stages 1,2,3,4 \\& 5 with estimated glomerular filtration rate \\[eGFR; MDRD\\] with mature permanent teeth.\n* \\> 18 years\n* \\> 8 natural teeth.\n* Complete medical \\& dental history including panoramic radiographs of maxilla \\& mandible\n\nExclusion Criteria:\n\n* Patients having systemic disorders other than CKD (eg HIV, Diabetes mellitus, Coronary heart disease, history of secondary hyperparathyroidism).\n* Pregnancy, lactation \\& contraceptives.\n* Systemic conditions that contra indicates dental treatment.\n* Use of antibiotics \\& anti-inflammatory in last 3 months\n* Need for antibiotic prophylaxis.\n* Hepatitis C and B virus.\n* Patients on steroids.'}, 'identificationModule': {'nctId': 'NCT05818657', 'briefTitle': 'Association of Apical Periodontitis With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Prevalence of of Apical Periodontal in Patients Chronic Kidney Disease & Its Association With Markers of Kidney Disease.', 'orgStudyIdInfo': {'id': 'Dr. Jyoti Lamba'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group-A CKD patients', 'description': 'Prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR \\& Systemic markers will be checked', 'interventionNames': ['Biological: levels of CKD markers, Oral health status, apical periodontitis']}, {'label': 'Group-B Healthy individuals', 'description': 'Prevalence of apical periodontitis will be checked and non-surgical root canal treatment will be given to the patients with apical periodontitis and change in PAI score, eGFR \\& Systemic markers will be checked', 'interventionNames': ['Biological: systemic inflammatory marker, Oral health status, apical periodontitis']}], 'interventions': [{'name': 'levels of CKD markers, Oral health status, apical periodontitis', 'type': 'BIOLOGICAL', 'description': 'To observe levels of CKD markers :Levels of serum keratinise ,urea, eGFR, and assessment of Oral health status, apical periodontitis', 'armGroupLabels': ['Group-A CKD patients']}, {'name': 'systemic inflammatory marker, Oral health status, apical periodontitis', 'type': 'BIOLOGICAL', 'description': 'estimation of hs-CRP levels, and assessment of Oral health status, apical periodontitis', 'armGroupLabels': ['Group-B Healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'PGIDS', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'overallOfficials': [{'name': 'Dr. Shweta Mittal, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Post Graduate Institute Of Dental Sciences, Rohtak.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}