Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT06806566
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2025-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used As a Palatal Dressing Following Free Gingival Graft Harvesting: a Randomized Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C073316', 'term': 'carvacrol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Biostatistician'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Operative Pain', 'timeFrame': '2 weeks', 'description': 'Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10. 0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain)'}], 'secondaryOutcomes': [{'measure': 'Color Match', 'timeFrame': '42 days', 'description': 'On day 3, day 7, day 14, day 21 and day 42, the color of the palatal mucosa will be assessed by comparing it with that of the adjacent and opposite side by using the objective VAS (VAS score 0-10) represented by a continuous line, by a clinician blinded to the treatment group assignment.\n\nA score of 0 indicates no color match, and a score of 10 indicates excellent color match with the adjacent tissues'}, {'measure': 'Wound Size', 'timeFrame': '21 days', 'description': 'To be recorded using (UNC15) periodontal probe to the nearest measurement of 0.5 mm at surgery day, day 3, day 7, day 14 and day 21'}, {'measure': 'Post-Operative Pain (Indirectly)', 'timeFrame': '3 Weeks', 'description': 'Postoperative pain, number of analgesic pills taken, and number of days pills were taken were assessed using questionnaires administered at the 3-day and 3-week postoperative appointments.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palatal Wound']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of carvacrol loaded to absorbable gelatin sponge as a palatal bandage on the palatal donor site in post-operative pain reduction after free gingival graft harvesting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1 - Patients with mucogingival defects scheduled for free gingival graft. 2- Medically free patients 3- Palate with sufficient connective tissue to accommodate soft tissue defects. 4- Good oral hygiene\n\nExclusion Criteria:\n\n1 - Smokers 2- Pregnancy 3- Medically compromised patients 4- Severe gag reflex 5- Patients allergic to the used agent 6- Occlusal trauma at the site of graft'}, 'identificationModule': {'nctId': 'NCT06806566', 'briefTitle': 'Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used As a Palatal Dressing Following Free Gingival Graft Harvesting: a Randomized Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Clinical Evaluation of Carvacrol Loaded Absorbable Gelatin Sponge As a Palatal Bandage After Free Gingival Graft Harvesting : a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '23-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Absorbable gelatin sponge soaked in carvacrol oil', 'interventionNames': ['Other: Carvacrol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Gelatin Sponge', 'interventionNames': ['Other: Gelatin Sponge Sheet']}], 'interventions': [{'name': 'Carvacrol', 'type': 'OTHER', 'description': '1-absorbable gelatine sponge soaked in carvacrol oil placed in the palatal donor site.\n\nProcedure:\n\nThe palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.\n\nThe graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length). Denuded palatal area will then be protected using a carvacrol loaded absorbable gelatin sponge (test group)', 'armGroupLabels': ['Test Group']}, {'name': 'Gelatin Sponge Sheet', 'type': 'OTHER', 'description': 'Absorbable gelatin sponge placed in the palatal donor site\n\nProcedure:\n\nThe palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.\n\nThe graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length). Denuded palatal area will then be protected using a absorbable gelatin sponge(control group).', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Amin i. Amin, Bachelors degree in dentistry', 'role': 'CONTACT', 'email': 'PG.Amin92142017@bue.edu.eg', 'phone': '+201099922346'}], 'facility': 'The british university in egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amin I. Amin, Bachelors degree in dentisrty', 'role': 'CONTACT', 'email': 'PG.Amin92142017@bue.edu.eg', 'phone': '+201099922346'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amin', 'investigatorAffiliation': 'British University In Egypt'}}}}