Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT01945632
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2013-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Root Planing on Surface Topography.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'lastUpdateSubmitDate': '2013-09-17', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface roughness', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'In a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing with piezoelectric ultrasonic scraper \\[PU\\]; or 4) root planing with vertically oscillating ultrasonic device \\[VOU\\]. Post-treatment, the teeth will be extracted and their topography analyzed in 124 observations with white light confocal microscopy, measuring the roughness parameters Rp, Rv, Rt, Ra, Rq, Rku, and Rsk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing programmed tooth extraction for chronic advanced periodontitis.\n\nExclusion Criteria:\n\n* Patients with no advanced periodontitis or patients that refused the treatment.'}, 'identificationModule': {'nctId': 'NCT01945632', 'briefTitle': 'Effect of Root Planing on Surface Topography.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'orgStudyIdInfo': {'id': 'root planing tophography'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'no treatment', 'description': 'Control group with no treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'root planing (gracey curettes)', 'description': 'treatment with root planing using conventional gracey curettes', 'interventionNames': ['Device: conventional gracey curettes']}, {'type': 'EXPERIMENTAL', 'label': 'Vertically oscillating ultrasonic device', 'description': 'Treatment done with vertically oscillating ultrasonic device', 'interventionNames': ['Device: Vertically oscillating ultrasonic device']}, {'type': 'EXPERIMENTAL', 'label': 'Device: piezoelectric ultrasonic scraper', 'description': 'Treatment using a piezoelectric ultrasonic scraper', 'interventionNames': ['Device: piezoelectric ultrasonic scraper']}], 'interventions': [{'name': 'conventional gracey curettes', 'type': 'DEVICE', 'armGroupLabels': ['root planing (gracey curettes)']}, {'name': 'Vertically oscillating ultrasonic device', 'type': 'DEVICE', 'armGroupLabels': ['Vertically oscillating ultrasonic device']}, {'name': 'piezoelectric ultrasonic scraper', 'type': 'DEVICE', 'armGroupLabels': ['Device: piezoelectric ultrasonic scraper']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'School of Dentistry, University of Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD.', 'investigatorFullName': 'Juan Ignacio Rosales Leal', 'investigatorAffiliation': 'Universidad de Granada'}}}}