Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT03156569
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salivary Markers in Patients With Xerostomia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'saliva flow rate', 'timeFrame': '2 months', 'description': 'Unstimulated salivary flow rate. Pathological \\< or 1.5 ml/ 15 minutes.'}, {'measure': 'Xerostomia', 'timeFrame': '2 months', 'description': 'Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).'}, {'measure': 'Interleukins', 'timeFrame': '2 months', 'description': 'Analytes in saliva IFN-(pg/ml), IL-10(pg/ml), IL-1b(pg/ml), IL-4 (pg/ml)and IL-6 (pg/ml)'}], 'secondaryOutcomes': [{'measure': 'Oral Exam', 'timeFrame': '4 months', 'description': 'Caries number, natural teeth number'}, {'measure': 'Periodontal evaluation', 'timeFrame': '4 months', 'description': 'periodontal( gingival index, bleeding index, clinical attachment level, probing depth,number dental implant .A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects according to American Academy of Periodontology classification of periodontal diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['saliva , dental , oral health'], 'conditions': ['Xerostomia Due to Hyposecretion of Salivary Gland']}, 'referencesModule': {'references': [{'pmid': '24750447', 'type': 'BACKGROUND', 'citation': "Ohyama K, Moriyama M, Hayashida JN, Tanaka A, Maehara T, Ieda S, Furukawa S, Ohta M, Imabayashi Y, Nakamura S. Saliva as a potential tool for diagnosis of dry mouth including Sjogren's syndrome. Oral Dis. 2015 Mar;21(2):224-31. doi: 10.1111/odi.12252. Epub 2014 May 15."}, {'pmid': '17451498', 'type': 'RESULT', 'citation': 'van den Berg I, Pijpe J, Vissink A. Salivary gland parameters and clinical data related to the underlying disorder in patients with persisting xerostomia. Eur J Oral Sci. 2007 Apr;115(2):97-102. doi: 10.1111/j.1600-0722.2007.00432.x.'}, {'pmid': '27541079', 'type': 'RESULT', 'citation': 'Liukkonen J, Gursoy UK, Pussinen PJ, Suominen AL, Kononen E. Salivary Concentrations of Interleukin (IL)-1beta, IL-17A, and IL-23 Vary in Relation to Periodontal Status. J Periodontol. 2016 Dec;87(12):1484-1491. doi: 10.1902/jop.2016.160146. Epub 2016 Aug 19.'}, {'pmid': '30030617', 'type': 'DERIVED', 'citation': "Tvarijonaviciute A, Zamora C, Martinez-Subiela S, Tecles F, Pina F, Lopez-Jornet P. Salivary adiponectin, but not adenosine deaminase, correlates with clinical signs in women with Sjogren's syndrome: a pilot study. Clin Oral Investig. 2019 Mar;23(3):1407-1414. doi: 10.1007/s00784-018-2570-3. Epub 2018 Jul 20."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient', 'detailedDescription': 'Primary Outcome Measures:\n\n* salivary Proinflammatory and anti-inflammatory cytokines\n* questionnaire is provided to the patient for xerostomia characterization\n\nSecondary Outcome Measures:\n\n* Probing pocket depth\n* Probing pocket depth and clinical attachment level\n* Gingival index\n* Plaque index\n* Bleeding on probing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Oral Medicine Hospital Morales Meseguer Clinica Odontologica University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• The patient must have clinical symptoms of xerostomia (dry mouth)\n\nExclusion Criteria:\n\n* Head and neck radiotherapy\n* Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months\n* Patients who are unable or unwilling to cooperate\n* Patient suffering from cancer'}, 'identificationModule': {'nctId': 'NCT03156569', 'briefTitle': 'Salivary Markers in Patients With Xerostomia', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Oral Health and Salivary Markers in Patients With Xerostomia', 'orgStudyIdInfo': {'id': 'University of Murcia'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Analysis of the saliva', 'type': 'DIAGNOSTIC_TEST', 'description': 'IFN-, IL-10, IL-1b, IL-4 and IL-6'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30004', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Pia Lopez Jornet', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Pia Lopez Jornet', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD DDS PhD', 'investigatorFullName': 'Pia Lopez Jornet', 'investigatorAffiliation': 'Universidad de Murcia'}}}}