Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-02 @ 1:44 AM
Study NCT ID:
NCT05386667
Status:
COMPLETED
Last Update Posted:
2022-05-23
First Post:
2022-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Landry's Wound Healing Index (WHI)", 'timeFrame': '21 days', 'description': 'WHI was performed on the basis of postoperative healing characteristics categorized as tissue color, response to palpation, incision margins, and suppuration.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '21 days', 'description': 'Recording the pain perception of the patients on a scale from 0 to 10. 0 - no pain 10 - worst pain'}, {'measure': 'Color match', 'timeFrame': '21 days', 'description': "scoring the color match of the healed tissue area with the patient's remaining tissue"}, {'measure': 'delayed bleeding', 'timeFrame': '21 days', 'description': 'examining the patient whether there is postoperative bleeding, if there is a positive, if not, it should be recorded as negative.'}, {'measure': 'burning sensation', 'timeFrame': '21 days', 'description': "Evaluation of the burning sensation felt in the healing area of the patient's palate from 0 to 10. 0-no burning sensation 10- excessive burning"}, {'measure': 'complete epithelization', 'timeFrame': '21 days', 'description': 'Examination of epithelialization with 3% oxygenated water. keeping records according to the foaming rate in the tissue'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Healing Wound', 'Hemorrhage', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '30007054', 'type': 'BACKGROUND', 'citation': 'Isler SC, Eraydin N, Akkale H, Ozdemir B. Oral flurbiprofen spray for mucosal graft harvesting at the palatal area: A randomized placebo-controlled study. J Periodontol. 2018 Oct;89(10):1174-1183. doi: 10.1002/JPER.17-0381. Epub 2018 Aug 29.'}, {'pmid': '34426739', 'type': 'BACKGROUND', 'citation': 'Hassan A, Ahmed E, Ghalwash D, Elarab AE. Clinical Comparison of MEBO and Hyaluronic Acid Gel in the Management of Pain after Free Gingival Graft Harvesting: A Randomized Clinical Trial. Int J Dent. 2021 Aug 14;2021:2548665. doi: 10.1155/2021/2548665. eCollection 2021.'}, {'pmid': '28914592', 'type': 'BACKGROUND', 'citation': 'Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.'}]}, 'descriptionModule': {'briefSummary': 'In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG).', 'detailedDescription': 'In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting. The effectiveness of these 3 different commercially available agents containing flurbiprofen, hyaluronic acid, and hypochlorous acid, after use 2., 4.7. and on the 14th day, wound healing and pain perception was compared with the control group. primary observation was obtained by visual analog scale, wound healing index, bleeding of tissue, color match, and amount of painkiller used by the patient were also recorded'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population of the study consists of all patients, who were planned to be applied free gingival graft for mucogingival surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:- Patients with systematic conditions are classified as The American Society of Anesthesiologists Class I\n\n\\-\n\nExclusion Criteria:\n\n* Pregnancy, lactation, and taking contraceptive pills.\n* Oversensitivity or anaphylactic reactions which contraindicate the intervention.\n* Orofacial neurological symptoms.\n* Infections at operation zone.\n* Psychotropic medicine, sedative, or non-steroid anti-inflammatory drugs use which can alter the sense of pain.\n* Pathological mental conditions (dementia, psychosis) and lack of cooperation.\n* Smoking\n* Excessive gag reflex\n* Operations are carried out with conscious sedation.\n* Patients who do not want to sign consent.'}, 'identificationModule': {'nctId': 'NCT05386667', 'briefTitle': 'Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.', 'orgStudyIdInfo': {'id': '05.03.2019/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Patients were not given anything after FGG.', 'interventionNames': ['Procedure: Free gingival graft harvesting']}, {'label': 'Flurbiprofen', 'description': 'Oral spray containing 0.075 g flurbiprofen administered after FGG', 'interventionNames': ['Drug: Majezik %0.25 oral spray', 'Procedure: Free gingival graft harvesting']}, {'label': 'Hypochlorous acid', 'description': 'Oral spray containing hypochlorous acid applied after FGG', 'interventionNames': ['Other: Crystalin oral spray', 'Procedure: Free gingival graft harvesting']}, {'label': 'Hyaluronic acid', 'description': 'An oral spray containing the main component of the product is hyaluronic acid (sodium salt) with a high molecular weight of 30 mg / 100 g was given to patients after FGG', 'interventionNames': ['Other: Aftamed oral spray', 'Procedure: Free gingival graft harvesting']}], 'interventions': [{'name': 'Majezik %0.25 oral spray', 'type': 'DRUG', 'otherNames': ['Free gingival graft harvesting'], 'description': 'Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.\n\nAfter FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.', 'armGroupLabels': ['Flurbiprofen']}, {'name': 'Aftamed oral spray', 'type': 'OTHER', 'otherNames': ['Free gingival graft harvesting'], 'description': 'Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.\n\nAfter FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.', 'armGroupLabels': ['Hyaluronic acid']}, {'name': 'Crystalin oral spray', 'type': 'OTHER', 'otherNames': ['Free gingival graft harvesting'], 'description': 'Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.\n\nAfter FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.', 'armGroupLabels': ['Hypochlorous acid']}, {'name': 'Free gingival graft harvesting', 'type': 'PROCEDURE', 'description': 'Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.', 'armGroupLabels': ['Control', 'Flurbiprofen', 'Hyaluronic acid', 'Hypochlorous acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20070', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University Faculty of Dentistry Department of Periodontology', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'AYSAN LEKTEMUR ALPAN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale Univesity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We may share the obtained data personally, but the decision of this is not yet clear.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Profesor', 'investigatorFullName': 'AYSAN LEKTEMUR ALPAN', 'investigatorAffiliation': 'Pamukkale University'}}}}