Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
Study NCT ID:
NCT00587834
Status:
COMPLETED
Last Update Posted:
2012-11-08
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@organo.com', 'phone': '781-575-0775', 'title': 'Director of Clinical Operations', 'organization': 'Organogenesis Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can review communications prior to public release and can embargo communications regarding trial results for at least 30 days in advance of public release. The sponsor can request removal of any confidential or proprietary information provided by sponsor and extend such review period for another 90 days to file patent applications or take other steps to protect the sponsor's intellectual property interests.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Secondary outcome measures were tested with a closed testing strategy; therefore pain was not tested (no p-value) because previous endpoint (site sensitivity) failed.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Gintuit', 'description': 'Adverse events occurring at the Gintuit treated site', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Free Gingival Graft', 'description': 'Adverse events occurring at the autologous free gingival graft site', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Palatal Donation Site', 'description': 'Adverse events occurring at the palatal donation site', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Mouth', 'description': 'Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites.', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Other', 'description': 'Adverse events occurring at any other location in the body or systemic conditions', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest Pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Malignant Metastatic Fibrous Histiocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gintuit', 'description': 'Single application;split-mouth design'}], 'classes': [{'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '98.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Superiority relative to a pre-defined standard (50% success)', 'statisticalMethod': 'Exact Bionomial Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol the first 2 subjects per Investigator were training subjects and evaluated for safety only. There were 11 training subjects and the remaining 85 subjects were analyzed for all efficacy outcomes.'}, {'type': 'SECONDARY', 'title': 'Color Same as Adjacent Tissues After 6 Months (Superiority)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gintuit Equally Red as Adjacent Tissue'}, {'id': 'OG001', 'title': 'Gintuit Not Equally Red as Adjacent Tissue', 'description': 'Not Equally Red includes responses of "more red" and "less red"'}], 'classes': [{'title': 'Control Equally Red as Adjacent Tissue', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Control Not Equally Red as Adjacent Tissue', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally red', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Red", "Equally Red", or "Less Red" as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'See description in primary outcome measure.'}, {'type': 'SECONDARY', 'title': 'Texture Same as Adjacent Tissues After 6 Months (Superiority)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gintuit Equally Firm as Adjacent Tissue'}, {'id': 'OG001', 'title': 'Gintuit Not Equally Firm as Adjacent Tissue', 'description': 'Not Equally Firm includes responses of "less firm" and "more firm"'}], 'classes': [{'title': 'Control Equally Firm as Adjacent Tissue', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Control Not Equally Firm as Adjacent Tissue', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firm', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Firm", "Equally Firm", or "Less Firm" as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'See description in primary outcome measures.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gintuit', 'description': 'Single application;split-mouth design'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Superiority relative to a pre-defined threshold (80%) success', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'See description in primary outcome measure.'}, {'type': 'SECONDARY', 'title': 'Patient Preference After 6 Months/Early Termination (Superiority)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gintuit', 'description': 'Single application of Gintuit and FGG (control); split-mouth design. Number of subjects preferring Gintuit over Control.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '61.0', 'upperLimit': '81.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'The proportion of Gintuit as the preferred procedure.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of patients expressing preference for Gintuit.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'See description in primary outcome measure.'}, {'type': 'SECONDARY', 'title': 'Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gintuit Not Sensitive', 'description': 'Included ratings of None and Mild'}, {'id': 'OG001', 'title': 'Gintuit Sensitive', 'description': 'Included ratings of Moderate and Severe'}], 'classes': [{'title': 'Control Not Sensitive', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Control Sensitive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3173', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "McNemar's paired comparison test", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'See description in primary outcome measures. The presence of Coe-Pak (protective periodontal dressing) at Week 1 prohibited the assessment of sensitivity for 14 subjects. The analysis was performed on 71 of the 85 subjects evaluated for efficacy.'}, {'type': 'SECONDARY', 'title': 'Pain Absent After 3 Days (Superiority)', 'paramType': 'NUMBER', 'timeFrame': 'Day 3', 'description': 'Pain Assessment(Modified Intent-to-Treat Population)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gintuit and Autologous Free Gingival Graft (FGG)', 'description': 'Single application of Gintuit and FGG (control); split-mouth design'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gintuit and Autologous Free Gingival Graft (FGG)', 'description': 'Single application of Gintuit and FGG (control); split-mouth design'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.14', 'spread': '13.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'dispFirstSubmitDate': '2010-01-22', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-09', 'studyFirstSubmitDate': '2007-12-21', 'dispFirstSubmitQcDate': '2010-01-22', 'resultsFirstSubmitDate': '2012-04-04', 'studyFirstSubmitQcDate': '2007-12-21', 'dispFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-09', 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.', 'timeFrame': '6 months', 'description': 'The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.'}], 'secondaryOutcomes': [{'measure': 'Color Same as Adjacent Tissues After 6 Months (Superiority)', 'timeFrame': '6 months', 'description': 'An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Red", "Equally Red", or "Less Red" as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.'}, {'measure': 'Texture Same as Adjacent Tissues After 6 Months (Superiority)', 'timeFrame': '6 months', 'description': 'An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Firm", "Equally Firm", or "Less Firm" as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.'}, {'measure': 'Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.', 'timeFrame': '6 months', 'description': 'The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.'}, {'measure': 'Patient Preference After 6 Months/Early Termination (Superiority)', 'timeFrame': '6 months', 'description': 'Number of patients expressing preference for Gintuit.'}, {'measure': 'Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)', 'timeFrame': '6 months', 'description': 'The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.'}, {'measure': 'Pain Absent After 3 Days (Superiority)', 'timeFrame': 'Day 3', 'description': 'Pain Assessment(Modified Intent-to-Treat Population)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '21513473', 'type': 'RESULT', 'citation': 'McGuire MK, Scheyer ET, Nevins ML, Neiva R, Cochran DL, Mellonig JT, Giannobile WV, Bates D. Living cellular construct for increasing the width of keratinized gingiva: results from a randomized, within-patient, controlled trial. J Periodontol. 2011 Oct;82(10):1414-23. doi: 10.1902/jop.2011.100671. Epub 2011 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 18 years of age but no more than 70 years of age.\n* Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with an insufficient zone (\\< or = 1mm) of attached gingiva that requires soft tissue grafting. (1-3 teeth may be treated. In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment).\n* Root coverage is not desired at the time of grafting.\n* Females of childbearing potential must have a documented negative urine pregnancy test.\n* Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.\n* Subjects must be able and willing to follow study procedures and instructions.\n\nExclusion Criteria:\n\n* Subject with class III recession in the presence of a shallow vestibule or class IV recession.\n* Subject with vestibule depth of less than 7mm from base of recession.\n* Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (i.e., diabetes mellitus, cancer, human immunodeficiency virus (HIV), bone metabolic diseases).\n* Subject who is currently receiving or has received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.\n* Subject with the presence of acute infectious lesions in the areas intended for surgery.\n* Subject who has used any tobacco product within 3 months.\n* Subject who is taking intramuscular or intravenous bisphosphonates.\n* Subject with only molar teeth suitable for soft tissue grafting.\n* Subject with teeth that have Miller Grade 2 or higher mobility.\n* Subject with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).\n* Subject who has received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).\n* Subject who was previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s) or immediately adjacent teeth.\n* Subject, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.'}, 'identificationModule': {'nctId': 'NCT00587834', 'briefTitle': 'Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organogenesis'}, 'officialTitle': 'A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing', 'orgStudyIdInfo': {'id': '06-PER-002-CTX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Within-subject design: one side of the mouth receives Gintuit', 'interventionNames': ['Device: Gintuit']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Within-subject control: one side of mouth receives tissue harvested from the palate', 'interventionNames': ['Other: Autologous palatal tissue']}], 'interventions': [{'name': 'Gintuit', 'type': 'DEVICE', 'description': 'Application of Gintuit at Day 0 to the gingival bed', 'armGroupLabels': ['1']}, {'name': 'Autologous palatal tissue', 'type': 'OTHER', 'description': "Tissue will be harvested from the subject's palate and placed on the gingival bed", 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Nevins Perio, LLC', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center for Oral Health Research', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Perio Health Professionals, PLLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229-3900', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Michael McGuire, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Perio Health Professionals, PLLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organogenesis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}