Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-29 @ 1:03 AM
Study NCT ID:
NCT03032094
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2017-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connective Tissue Grafting for Single Tooth Recession & the Impact of the Thickness of the Palatal Harvest Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root coverage', 'timeFrame': 'Upto 3 months', 'description': 'Amount of root coverage attained in millimeters'}, {'measure': 'Root coverage', 'timeFrame': 'Upto 3 months', 'description': 'Amount of root coverage attained in percentage'}, {'measure': 'width of keratinized tissue', 'timeFrame': 'Upto 3 months', 'description': 'Amount of zone of keratinized tissue attained in millimeters'}, {'measure': 'width of keratinized tissue', 'timeFrame': 'Upto 3 months', 'description': 'Amount of zone of keratinized tissue attained in percentage'}], 'secondaryOutcomes': [{'measure': 'thickness of keratinized tissue', 'timeFrame': 'Upto 3 months'}, {'measure': 'amount of erythema and edema', 'timeFrame': 'Upto 3 months', 'description': 'patient reported outcome of amount of erythema and edema in number of days postoperatively'}, {'measure': 'duration of erythema and edema', 'timeFrame': 'Upto 3 months', 'description': 'patient reported outcome of duration of erythema and edema in number of days postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Recession'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test if the thickness of the graft taken from the roof of the mouth, has a significant effect on the amount of attached tissue and the amount of root coverage that are attained when treating a single tooth with gingival recession.', 'detailedDescription': 'The goal of the study is to determine if the thickness of a tissue graft taken from the roof of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the root coverage, the health of the resulting tissue, as well as postoperative pain as reported by the patient. Connective tissue grafts will be harvested in different thicknesses, and results of the procedures will be compared. Qualified subjects will undergo a root coverage procedure, after random assignment to one of the groups. Regular recall visits to monitor healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. Subjects will be asked to fill out patient response forms regarding pain and other symptoms at these visits. Photographs will be taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\\>18 years old\n2. Absence of active periodontal disease\n3. Single tooth (premolars and anterior teeth) with Miller class I or II gingival recession \\>= 2mm\n4. Detectable Cemento-Enamel Junction (CEJ) -\n\nExclusion Criteria:\n\n1. Smokers (\\>10 cigarettes/ per day)\n2. Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c \\>7%)\n3. Active infectious diseases (hepatitis, tuberculosis, HIV, etc.)\n4. Medication known to cause gingival enlargement\n5. Patients taking anticoagulants with an international normalized ratio (INR) \\>2.5\n6. Long-term (\\>2 weeks) use of antibiotics in the past 3 months\n7. Pregnant or attempting to get pregnant\n8. Sites with probing depth \\> 4mm\n9. Recession adjacent to an edentulous area\n10. Frenal and muscle attachment that encroach on the marginal gingiva\n\n a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy)\n11. History of periodontal surgical treatment of the involved sites\n12. Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth\n13. Teeth with pulpal pathology\n14. Severe teeth malposition and open contacts\n15. Planned orthodontic treatment to commence within 1 year following procedure\n16. Parafunctional habits -'}, 'identificationModule': {'nctId': 'NCT03032094', 'briefTitle': 'Connective Tissue Grafting for Single Tooth Recession & the Impact of the Thickness of the Palatal Harvest Tissue', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study', 'orgStudyIdInfo': {'id': 'AAAN2667'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1mm thick graft', 'description': 'connective tissue graft of 1mm thickness', 'interventionNames': ['Procedure: connective tissue graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2mm thick graft', 'description': 'connective tissue graft of 2mm thickness', 'interventionNames': ['Procedure: connective tissue graft']}], 'interventions': [{'name': 'connective tissue graft', 'type': 'PROCEDURE', 'description': 'palatal connective tissue graft to attain root coverage', 'armGroupLabels': ['1mm thick graft', '2mm thick graft']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Evanthia Lalla, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Dental Medicine (Periodontics)', 'investigatorFullName': 'Evanthia Lalla', 'investigatorAffiliation': 'Columbia University'}}}}