Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 2:44 PM
Study NCT ID:
NCT06755333
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2024-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2024-12-24', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPD', 'timeFrame': 'measured at enrolment (T0) and 9 days after engraftment (T1)', 'description': 'probing pocket depth (PPD) was measured as the distance from the free gingival margin to the bottom of the pocket by inserting a periodontal probe parallel to the longitudinal axis of the tooth using a periodontal probe (UNC 15, Hu-Friedy, Chicago, IL, USA) and a calibrated pressure of 0.3 N. All measurements were rounded to the nearest millimetre.'}, {'measure': 'FMBS', 'timeFrame': 'measured at enrolment (T0) and 9 days after engraftment (T1)', 'description': 'Full Mouth Bleeding Score (FMBS) was measured dichotomously after periodontal probing. The mean bleeding score was indicated as percentage of sites detected positive for bleeding on the total number of sites'}, {'measure': 'FMPS', 'timeFrame': 'measured at enrolment (T0) and 9 days after engraftment (T1)', 'description': 'Full Mouth Plaque Score (FMPS) was assessed the presence or absence of plaque on each tooth surface. The presence of plaque was evaluated as 1, while the absence as 0, on 6 sites per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual, mesiolingual). Mean plaque score was indicated as percentage of sites found positive for the presence of plaque on the total number of sites'}, {'measure': 'CI', 'timeFrame': 'measured at enrolment (T0) and 9 days after engraftment (T1)', 'description': 'Calculus Index was measured using a probe and considering supragingival and subgingival calculus separately, with score 0 assigned in the absence of calculus and score 3 assigned to supragingival calculus exceeding two-thirds of the crown and/or continuous bands of subgingival calculus'}, {'measure': 'PRESENCE OF MUCOSITIS', 'timeFrame': 'measured 9 days after engraftment (T1)', 'description': 'Presence of mucositis was evaluated as the presence of mucosal erythema or ulceration for 8 oral sites and assigning a score from 0 (normal oral mucosa) to 5 (\\>3 sites of ulceration).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hematopoietic Stem Cell Transplantation', 'Dental Prophylaxis', 'Oral Hygiene', 'Motivation'], 'conditions': ['Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'This study assessed the effectiveness of a preventive protocol that included oral hygiene measures, patient education, and motivational strategies in individuals eligible for hematopoietic stem cell transplantation (HSCT).', 'detailedDescription': 'At baseline (T0), the patient underwent a professional oral hygiene session prior to initiating chemotherapy, as part of the routine pre-transplant protocol. During this session, periodontal charting was completed, and patients were provided with oral hygiene instructions.\n\nFollowing admission, patients received pre-transplant conditioning chemotherapy. Once engraftment of the transplant was confirmed by the Hematology Unit (9 days after engraftment), clinical parameters were reassessed (T1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing autologous hematopoietic stem cell transplantation (HSCT) for hematologic diseases. The study included patients treated at the Hematology Unit of Pisa University Hospital. Participants were selected based on their eligibility for HSCT and their consent to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patients\n* aged 18-75 years\n* patients scheduled for HSCT\n* acceptance of study participation\n* compliance to follow-up\n\nExclusion Criteria:\n\n\\- denial of the consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT06755333', 'briefTitle': 'Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Oral Hygiene Management of Hematologic Patients Undergoing Auto-transplantation: Observational Study', 'orgStudyIdInfo': {'id': '150782024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oral hygiene motivation', 'type': 'BEHAVIORAL', 'description': 'the patient underwent a professional oral hygiene session before starting chemotherapy, as part of the routine pre-transplant procedure. Patients then received oral hygiene instructions.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pisa', 'country': 'Italy', 'facility': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator', 'investigatorFullName': 'Rossana Izzetti', 'investigatorAffiliation': 'University of Pisa'}}}}