Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:16 AM
Study NCT ID:
NCT07306403
Status:
COMPLETED
Last Update Posted:
2025-12-29
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE COMPARISON OF GELATIN SPONGE TO SUTURE ALONE ON POST OPERATIVE SWELLING AFTER EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}, {'id': 'D008933', 'term': 'Mitochondrial Swelling'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-25', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2025-12-25', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Extraction Swelling', 'timeFrame': 'Pre extraction, 1st day post extraction, 3rd day post extraction and 7th day post extraction.', 'description': 'Measurements will be taken from angle of mandible to commissure of lips by measuring tape by Amin and Laskin Method.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Post Operative Swelling', 'Impacted Mandibular Third Molar Extraction']}, 'descriptionModule': {'briefSummary': 'This Study is designed for purpose to increase patient safety and reduce complications which occurs after mandibular 3rd molar extraction which is will increase discomfort after extraction. My study hypothesis is that gelatin sponge after extraction reduce swelling post extraction wisdom tooth.For understanding when we remove wisdom tooth, we involve hard and soft tissiues which will result in post extraction swelling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-30 years old.\n2. Either gender.\n3. impacted third mandibular molar.\n4. No history of periodontists\n5. No bone recession on radiograph\n6. Swelling at the side of impaction.\n\nExclusion Criteria:\n\n1. Patients with ASA status lll and above.\n2. -Patients requiring multiple extractions in same appointment.\n3. Patients allergic to Lignocaine.\n4. Patients in whom adrenaline is contraindicated.\n5. Medically compromised individual such as those with poorly controlled diabetes, hypertension and pregnancy,'}, 'identificationModule': {'nctId': 'NCT07306403', 'acronym': 'Gelatin Sponge', 'briefTitle': 'THE COMPARISON OF GELATIN SPONGE TO SUTURE ALONE ON POST OPERATIVE SWELLING AFTER EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR.', 'organization': {'class': 'OTHER', 'fullName': 'Watim Medical & Dental College'}, 'officialTitle': 'THE COMPARISON OF GELATIN SPONGE TO SUTURE ALONE ON POST OPERATIVE SWELLING AFTER EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR.', 'orgStudyIdInfo': {'id': 'Ethical Review Board'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Gelatin Sponge', 'description': 'Swelling', 'interventionNames': ['Device: Gelatin Sponge Sheet', 'Procedure: Swelling']}, {'type': 'OTHER', 'label': 'Suture Alone', 'description': 'Swelling', 'interventionNames': ['Device: Gelatin Sponge Sheet', 'Procedure: Swelling']}], 'interventions': [{'name': 'Gelatin Sponge Sheet', 'type': 'DEVICE', 'otherNames': ['Sponge Stone', 'Suture'], 'description': 'Gelatin sponge vs Suture Alone', 'armGroupLabels': ['Gelatin Sponge', 'Suture Alone']}, {'name': 'Swelling', 'type': 'PROCEDURE', 'description': 'Suture', 'armGroupLabels': ['Gelatin Sponge', 'Suture Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Islamabad', 'state': 'Federal', 'country': 'Pakistan', 'facility': 'Watim Medical and Dental College', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Because want to avoid sharing their identity'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Watim Medical & Dental College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The Comparison of Gelatin Sponge To Suture Alone on Post Operative Swelling After Extraction of Impacted Mandibular Third Molar', 'investigatorFullName': 'Dr.Mohammad Irfan', 'investigatorAffiliation': 'Watim Medical & Dental College'}}}}