Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT02013661
Status:
COMPLETED
Last Update Posted:
2013-12-17
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Sutures in Periodontal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence or absence of Suture loosening', 'timeFrame': 'seven days after surgery', 'description': 'Seven days after the surgical procedure, the surgeon assessed suture loosening; recording loose or not Loose'}], 'secondaryOutcomes': [{'measure': 'presence and level of erythema and edema.', 'timeFrame': 'seven days after surgery', 'description': 'Seven days after the surgical procedure a blind researcher clinically evaluated erythema and edema. Adding a score related to a gingival index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['periodontal debridement', 'sutures', 'tissue reaction'], 'conditions': ['Periodontal Debridement']}, 'descriptionModule': {'briefSummary': 'The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery.', 'detailedDescription': 'Forty patients participated in this prospective, randomized, double-blind clinical trial. Vertical mattress sutures were used following resective periodontal surgery performed by one operator. Four suture materials were selected for evaluation: 5-0 silk; 5-0 polypropylene; 5-0 polyglycolic acid (PGA), and 4-0 polytetrafluoroethylene (PTFE). Seven days after the surgical procedure, the surgeon assessed suture loosening and removed the sutures. A blind researcher clinically evaluated erythema and edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated at the CUO (dental clinic at the Universitat Internacional de Catalunya) that are prescribed for periodontal resective surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Qualification for the study was based on the need for resective periodontal surgery (apically positioned flap and osseous recontouring) at four or more consecutive interproximal sites per quadrant\n\nExclusion Criteria:\n\n* systemic diseases, such as diabetes, chronic obstructive pulmonary disease, or an immunologic disease that would affect wound healing; allergies to prescribed medication; and/or current pregnancy or breast feeding were excluded from the study'}, 'identificationModule': {'nctId': 'NCT02013661', 'briefTitle': 'Clinical Evaluation of Sutures in Periodontal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Clinical Evaluation of Four Types of Suture in Periodontal Surgery', 'orgStudyIdInfo': {'id': 'C-12-ASA-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suture in Periodontal resective surgery', 'description': 'Four types of suture including silk, polypropylene, PGA, and PTFE', 'interventionNames': ['Procedure: Periodontal resective surgery']}], 'interventions': [{'name': 'Periodontal resective surgery', 'type': 'PROCEDURE', 'description': 'surgical periodontal debridement is performed after periodontal phase I', 'armGroupLabels': ['Suture in Periodontal resective surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08195', 'city': 'San Cugat Del Valles', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Universitat Internacional de Catalunya'}], 'overallOfficials': [{'name': 'Jose Nart, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat Internacional de Catalunya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, Ms.', 'investigatorFullName': 'Almudena Tasende Pereiro', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}