Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03775967
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sialic acid and IL10 are assessed by taking salivary samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-23', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sialic acid levels in stage 1 periodontitis', 'timeFrame': 'From baseline to 3 months', 'description': 'Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients'}, {'measure': 'Sialic acid levels in stage 2 periodontitis', 'timeFrame': 'From baseline to 3 months', 'description': 'Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients'}, {'measure': 'IL10 levels in stage 1 periodontitis', 'timeFrame': 'From baseline to 3 months', 'description': 'IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients'}, {'measure': 'IL10 levels in stage 2 periodontitis', 'timeFrame': 'From baseline to 3 months', 'description': 'IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sialic acid', 'IL10', 'stage 1 periodontal disease', 'stage 2 periodontal disease'], 'conditions': ['Periodontal Disease']}, 'descriptionModule': {'briefSummary': 'Sialic acid (SA) is the generic term given to a family of acetylated derivatives of neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to regulate innate immunity. SA is present in several acute phase proteins which are known to be associated with periodontitis. There exists a need for a biomarker, for early detection of disease evolution and more robust therapy efficacy measurements. Till date, there is very little data regarding simultaneous estimation and comparison of total SA content in saliva. IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in both healthy and diseased human periodontal tissues and is reported to be reduced in patients infected with Aggregatibacter actinomycetemcomitans.\n\nThe present study was therefore undertaken with an aim, to not only assess the levels of TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage 2(moderate) periodontitis patients', 'detailedDescription': 'Selection of patients by grading the patients according to criteria stage 1 and 2 Periodontitis\n\nObtaining consent from patients participating in the study\n\nCollection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool box indicated for laboratory samples and transported to the lab for investigations. It will be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be measured in mg/dl,IL10 as in direct measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the subjects should be within the age group of 18 to 55 years\n* subject should have atleast 18 natural teeth excluding third molars.\n\nExclusion Criteria:\n\n* History of periodontal debridement or periodontal surgery in preceding six months or any antimicrobial therapy, anti-inflammatory drugs.\n* corticosteroids, in previous three months\n* systemically compromised individuals\n* smokers\n* pregnant and lactating women\n* Medical history for absence of systemic disorders such as diabetes mellitus\n* cardiovascular diseases\n* pneumonia\n* tuberculosis\n* rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT03775967', 'briefTitle': 'Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ajman University'}, 'officialTitle': 'Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients', 'orgStudyIdInfo': {'id': 'UGD-H-18-10-31-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sialic acid', 'type': 'DIAGNOSTIC_TEST', 'description': 'sialic acid level estimation in salivary samples'}, {'name': 'IL10', 'type': 'DIAGNOSTIC_TEST', 'description': 'IL10 estimation in salivary samples'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mangalore', 'country': 'India', 'facility': 'AB shetty institute of dental sciences', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'sudhir rama varma', 'investigatorAffiliation': 'Ajman University'}}}}