Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT04854902
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyanoacrylate Use in Free Gingival Graft
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003487', 'term': 'Cyanoacrylates'}, {'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D014014', 'term': 'Tissue Adhesives'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-epithelization', 'timeFrame': 'one week after the surgery', 'description': 'Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs'}, {'measure': 'Re-epithelization', 'timeFrame': 'two weeks after the surgery', 'description': 'Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs'}, {'measure': 'Re-epithelization', 'timeFrame': 'three weeks after the surgery', 'description': 'Donor site re-epithelization: hydrogen-peroxide is applied to the donor area with the help of an injector, and it is recorded as complete when no foaming occurs'}, {'measure': 'Post-operative pain', 'timeFrame': '1st week', 'description': 'Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)'}, {'measure': 'Post-operative pain', 'timeFrame': '2nd week', 'description': 'Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)'}, {'measure': 'Post-operative pain', 'timeFrame': '3rd week', 'description': 'Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)'}, {'measure': 'Post-operative pain', 'timeFrame': '4th week', 'description': 'Visual analogue scale (VAS) (0-10), self-reported outcome 0 - no pain (min.) 10 - unbearable (max.)'}, {'measure': 'Oral health impact profile (OHIP-14)', 'timeFrame': 'Baseline', 'description': 'The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality'}, {'measure': 'Oral health impact profile (OHIP-14)', 'timeFrame': '3rd day', 'description': 'The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality'}, {'measure': 'Oral health impact profile (OHIP-14)', 'timeFrame': '1st week', 'description': 'The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality'}, {'measure': 'Oral health impact profile (OHIP-14)', 'timeFrame': '1st month', 'description': 'The patients are asked to fill provided OHIP-14 forms Questionnaire about satisfaction related to oral health, scored as 0-4 (never - always) 14 questions in total 0 (min.) - 56 (max.) Lower scores represent higher oral health related life quality'}, {'measure': 'Graft dimensions', 'timeFrame': '1st month', 'description': 'Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm'}, {'measure': 'Graft dimensions', 'timeFrame': '3rd month', 'description': 'Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm'}, {'measure': 'Graft dimensions', 'timeFrame': '6th month', 'description': 'Mesio-distal (horizontal) and apico-coronal (vertical) width of the graft is measured with a periodontal probe, rounding to the nearest mm'}], 'secondaryOutcomes': [{'measure': 'Mucosal thickness', 'timeFrame': 'In the beginning of the surgery (baseline)', 'description': '15 endodontic reamer is inserted to the palatal mucosa 5 mm apical of the gingival margin of the second premolar; under local anesthesia'}, {'measure': 'Paresthesia / hyperesthesia in the donor site', 'timeFrame': '1st month', 'description': 'The patient marks the visual analogue scale (0-10) after rubbing the donor site with a periodontal probe (to give a reference, symmetrical area is rubbed first) 0 - Paresthesia / hyperesthesia, 10 - no sensation difference with the reference area'}, {'measure': 'Color harmony', 'timeFrame': '1st week', 'description': 'Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference'}, {'measure': 'Color harmony', 'timeFrame': '2nd week', 'description': 'Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference'}, {'measure': 'Color harmony', 'timeFrame': '1st month', 'description': 'Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference'}, {'measure': 'Color harmony', 'timeFrame': '3rd month', 'description': 'Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference'}, {'measure': 'Color harmony', 'timeFrame': '6th month', 'description': 'Color harmony between the graft and the neighboring keratinized tissue at the recipient site, examiner gives a score ranging 0-10 0 - completely different tone/color of the graft; 10 - no detectible tone difference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Localized']}, 'descriptionModule': {'briefSummary': 'Present study aims to reveal the effects of cyanoacrylate application at the recipient bed and the donor site in free gingival graft surgery on the healing parameters and patient-based outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single-tooth gingival recession in the anterior mandibular region\n* Pain with chewing or oral hygiene practice\n* Ongoing recession\n\nExclusion Criteria:\n\n* Systemic disease\n* Smoking\n* Pregnancy / lactation'}, 'identificationModule': {'nctId': 'NCT04854902', 'briefTitle': 'Cyanoacrylate Use in Free Gingival Graft', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'The Effects of Cyanoacrylate on Self-reported Outcomes and Healing Following Free Gingival Graft Surgery', 'orgStudyIdInfo': {'id': 'CAFGG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyanoacrylate', 'description': 'The graft is stabilized and the donor site is coated with cyanoacrylate.', 'interventionNames': ['Procedure: Free gingival graft', 'Procedure: Cyanoacrylate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suture', 'description': '6/0 polyvinylidene fluoride sutures are used for stabilization, while the donor site is left untreated.', 'interventionNames': ['Procedure: Free gingival graft', 'Procedure: Suture']}], 'interventions': [{'name': 'Free gingival graft', 'type': 'PROCEDURE', 'description': '1.5-2 x 5 x 10 mm size epithelialized graft harvested from the palate is stabilized in the mandibular anterior single-tooth recession region', 'armGroupLabels': ['Cyanoacrylate', 'Suture']}, {'name': 'Cyanoacrylate', 'type': 'PROCEDURE', 'description': 'N-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound', 'armGroupLabels': ['Cyanoacrylate']}, {'name': 'Suture', 'type': 'PROCEDURE', 'description': 'The graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed', 'armGroupLabels': ['Suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mustafa YILMAZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biruni University, assistant professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'one year after the publication', 'ipdSharing': 'YES', 'description': 'All IPD will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mustafa YILMAZ', 'investigatorAffiliation': 'Biruni University'}}}}