Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT01816269
Status:
UNKNOWN
Last Update Posted:
2013-03-22
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084063', 'term': 'Reinfection'}], 'ancestors': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-21', 'studyFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The eradication and reinfection rates in dental scaled and non-scaled patients.', 'timeFrame': 'last 1 year'}], 'secondaryOutcomes': [{'measure': 'Reinfection rate of patients treated for H.pylori', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Dental scaling', 'Eradication', 'Reinfection', 'Helicobacter status'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Patients who had received H.pylori eradication treatment will be categorised as eradication and reinfection status and whether dental scaling has any influence on these results.', 'detailedDescription': 'Patients over 18 years with no comorbidities especially liver, cardiac and haemorrhagic diathesis and giving informed consent will be categorised according to their status of dental scaling, eradication and reinfection rates of h.pylori.\n\nStatistical examination will include the multiple regression and Chi-Square.\n\nThe result will emphasize the influence of dental scaling on eradication (Presence of Hp cure 1-6 months after treatment) and reinfection ( reappearance of Hp 12 months later than the treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible population with H.pylori infection and result of treatment based on presence of dental scaling.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 with h.pylori positivity and received anti-Hp treatment giving informed consent to analyse of their data on this subject.\n\nExclusion Criteria:\n\n* Comorbidities with cardiac, liver and medical contraindication to perform dental scaling.'}, 'identificationModule': {'nctId': 'NCT01816269', 'acronym': 'Scaling and Hp', 'briefTitle': 'Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection', 'organization': {'class': 'OTHER', 'fullName': 'Goztepe Training and Research Hospital'}, 'officialTitle': 'Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection', 'orgStudyIdInfo': {'id': 'cu1959'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with scaling and patients without scaling', 'description': 'No drug'}, {'label': 'Helicobacter eradicated or non-eradicated'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34727', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'GoztepeTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'GoztepeTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goztepe Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Department of Gastroenterology', 'investigatorFullName': 'Celal Ulasoglu', 'investigatorAffiliation': 'Goztepe Training and Research Hospital'}}}}