Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-30 @ 6:22 PM
Study NCT ID:
NCT02659904
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-16', 'studyFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2016-01-16', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in remaining palatal tissue thickness', 'timeFrame': 'From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Free gingival graft', 'Palatal donor site healing'], 'conditions': ['Healthy', 'Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '27330024', 'type': 'DERIVED', 'citation': 'Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'Our primary objective in this clinical intervention study, therefore, was to explored the effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6 months after free gingival graft harvesting in order to determine as soon as possible to re-harvest gingival graft from same site.', 'detailedDescription': 'Forty individuals (19 males and 21 females; age range: 18-35 years) were enrolled in the study. Based on the remaining tissue at donor site after free gingival graft harvesting, individuals were divided into two groups: 1.0-1.9 millimeter (mm) remaining tissue at donor site after harvesting (n = 20), 2-2.9 mm remaining tissue at donor site after harvesting. Tissue filling in defect area from three points (mesial, central and distal) was measured at various time-points (baseline, post-operative 1, 3, 6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All individuals received oral hygiene instructions and full-mouth scaling was performed. -They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra-soft toothbrush\n* Individuals were re-evaluated at 8 weeks after initial therapy, and only full mounth plaque score and full mounth bleeding score \\<15% were enrolled to the surgical procedure\n* mucogingival defects which for soft tissue graft application were indicated\n* For Less than 2 mm group, between 2.5 and 3.4 mm palatal thickness at each measurement points before graft harvesting\n* For 2 mm or more group, between 3.5 and 4.4 mm palatal thickness at each measurement points before graft harvesting.\n\nExclusion Criteria:\n\n* periapical or palatal pathologies,\n* absence teeth from canine to first molar,\n* excessive forces including mechanical forces from orthodontics and occlusion,\n* systemic diseases that would contraindicate for periodontal surgery or interfere with tissue healing, chronic high-dose steroid therapy, radiation or immunosuppressive therapy, pregnancy, lactation, smoking, or allergy or sensitivity to any drug\n* Study participants had no history of drug therapy known to interfere with healing and to cause gingival enlargement\n* Individuals who had complication such as bleeding, necrosis and delay healing during or after surgery were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02659904', 'briefTitle': 'The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting', 'orgStudyIdInfo': {'id': '2015/103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Less than 2 mm', 'description': 'Palatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: Less than 2 mm remaining palatal tissue thickness', 'interventionNames': ['Other: Less than 2 mm remaining palatal tissue thickness']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 mm or more', 'description': 'Palatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: 2 mm or more remaining palatal tissue thickness', 'interventionNames': ['Other: 2 mm or more remaining palatal tissue thickness']}], 'interventions': [{'name': 'Less than 2 mm remaining palatal tissue thickness', 'type': 'OTHER', 'description': 'The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.', 'armGroupLabels': ['Less than 2 mm']}, {'name': '2 mm or more remaining palatal tissue thickness', 'type': 'OTHER', 'description': 'The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.', 'armGroupLabels': ['2 mm or more']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'İlker KESKINER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'İlker KESKINER', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}