Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 10:54 PM
Study NCT ID:
NCT05279950
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2020-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Full Mouth Ultrasonic Debridement Carried Out Either by Piezoelectric or Magnetostrictive Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004638', 'term': 'Emergency Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'through study completition, 1 year', 'description': 'vas scale (0-10) for perception of pain after treatment'}, {'measure': 'noise', 'timeFrame': 'through study completition, 1 year', 'description': 'vas scale (0-10) for perception of noise after treatment'}, {'measure': 'vibration', 'timeFrame': 'through study completition, 1 year', 'description': 'vas scale (0-10) for perception of vibration after treatment'}], 'secondaryOutcomes': [{'measure': 'pocket closure', 'timeFrame': 'through study completition, 1 year', 'description': 'change of pocket probing depth (millimeter) after treatment measured with a periodontal probe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis', 'patient centred outcomes', 'magnetostrictive'], 'conditions': ['Periodontitis, Adult']}, 'descriptionModule': {'briefSummary': 'Treatment of periodontitis requires removal of dental biofilm both through professional mechanical plaque removal and domiciliar oral hygiene procedures. This study aims to compare biometric and psychological results after professional treatment of periodontitis carried out by piezoelectric or magnetostrictive ultrasonic devices.', 'detailedDescription': 'Patients diagnosed with periodontitis will be assessed for eligibility criteria. Full-mouth periodontal assessment will be performed by an examiner to detect severity and extension of the disease. Thereafter, patient will receive oral hygiene instruction and a closed envelope with patient allocation will be opened. After the allocation to the intervention group, full-mouth ultrasonic debridement will be delivered to the patient by an operator and information about patient perception will be collected. Three months later, patients will be recalled for a new periodontal assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* periodontitis of stage 1 and 2\n* absence of systemic chronic disease\n\nExclusion Criteria:\n\n* anticoagulants treatment\n* antibiotic treatment 3 months before the screening visit'}, 'identificationModule': {'nctId': 'NCT05279950', 'briefTitle': 'Full Mouth Ultrasonic Debridement Carried Out Either by Piezoelectric or Magnetostrictive Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Clinical and Patient Centred Outcome Performance of Full Mouth Ultrasonic Debridement Carried Out for the Treatment of Periodontitis Performed Either by Piezoelectric or Magnetostrictive Device. A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MAG001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Piezoelectric', 'description': 'Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \\>18 kHz) powered by a piezoelectric device', 'interventionNames': ['Device: Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)']}, {'type': 'EXPERIMENTAL', 'label': 'Magnetostrictive', 'description': 'Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \\>18 kHz) powered by a magnetostrictive device.', 'interventionNames': ['Device: Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)']}], 'interventions': [{'name': 'Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)', 'type': 'DEVICE', 'description': 'the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal', 'armGroupLabels': ['Piezoelectric']}, {'name': 'Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)', 'type': 'DEVICE', 'description': 'the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal', 'armGroupLabels': ['Magnetostrictive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'AOUS', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'centralContacts': [{'name': 'nicola Discepoli', 'role': 'CONTACT', 'email': 'NDISCEPOLI@ME.COM', 'phone': '3395256148'}, {'name': 'Nicola Discepoli', 'role': 'CONTACT', 'email': 'ndiscepoli@me.com', 'phone': '0039 3395256148'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nicola Discepoli', 'investigatorAffiliation': 'University of Siena'}}}}