Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-27 @ 5:30 PM
Study NCT ID:
NCT05850650
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Post-extraction Collagen Sponge Application on Alveolar Osteitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004368', 'term': 'Dry Socket'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The participants (patients) will not be informed about which side will recieve the collagen'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will have surgical extraction of impacted 3rd molars for both sides with a gap of 3 weeks. The study side will receive a collage sponge after extraction followed by sutures. The controlled side will have sutures without a collagen sponge.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-30', 'studyFirstSubmitDate': '2023-03-19', 'studyFirstSubmitQcDate': '2023-04-30', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-extraction Pain score', 'timeFrame': 'Pre-extraction', 'description': 'Pain measurement by VAS (0-10). 0: no pain. 10: worst pain'}, {'measure': 'Pre-extraction Halitosis', 'timeFrame': 'Pre-extraction', 'description': "Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech"}, {'measure': 'Pre-extraction Mouth opening', 'timeFrame': 'Pre-extraction', 'description': 'Maximum Mouth opening is taken by a caliber'}, {'measure': 'Pain score Day3', 'timeFrame': '3 days after extraction', 'description': 'Pain measurement by VAS (0-10). 0: no pain. 10: worst pain'}, {'measure': 'Pain score Day7', 'timeFrame': '7 days after extraction', 'description': 'Pain measurement by VAS (0-10). 0: no pain. 10: worst pain'}, {'measure': 'Mouth opening Day7', 'timeFrame': '7 days after extraction', 'description': 'Maximum Mouth opening is taken by a caliber'}, {'measure': 'Halitosis Day7', 'timeFrame': '7 days after extraction', 'description': "Halitosis in reported in the presence of a bad odor that is smelled by the investigator during the patient's speech"}, {'measure': 'Alveolar osteitis', 'timeFrame': 'After 3 days of extraction', 'description': 'is diagnosed if the patient complains of pain (more than 5) between day 2 and day 4 with empty sockets and food debris, with or without halitosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alveolar osteitis', 'Collagen sponge', 'Impacted lower third molar'], 'conditions': ['Alveolar Osteitis']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare pain, mouth opening, and alveolar osteitis following surgical extraction of bilateral symmetrical impacted lower third molars using two types of wound closures. Collagen plugs will be applied in the sockets of the study side followed by suture, while the controlled side will be sutured without a collagen plug. The study will include 40 patients aged between 18- 40 years old, medically fit (ASA1), who have bilateral symmetrical impacted lower third molars and visit the oral surgery clinics of King Saud Medical City for extraction. The main question is" Does intra-alveolar collagen application after surgical extraction of impacted lower third molars reduce the incidence of alveolar osteitis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nForty patients aged between 18- 40 years old, ASA1, who have bilateral symmetrical impacted lower third molars and visit the oral surgery clinics of King Saud Medical City for extraction.\n\nExclusion Criteria:\n\nUncontrolled systemic diseases, diabetes, bone diseases, smokers, epinephrine contraindications, pregnant women, breastfeeding women, and those who were using oral contraceptives.\n\nOther exclusion criteria are the presence of acute infection and facial swelling, cystic lesions, and TMJ problems. Moreover, any surgical extraction that lasts more than 30 minutes +/- 5 minutes, or has been done without the whole standardized steps will be excluded.'}, 'identificationModule': {'nctId': 'NCT05850650', 'briefTitle': 'The Effect of Post-extraction Collagen Sponge Application on Alveolar Osteitis', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Colleges of Dentistry and Pharmacy'}, 'officialTitle': 'The Effect of Collagen Sponge Placed in the Socket After Surgical Extraction of Mandibular Third Molars on the Incidence of Alveolar Osteitis. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Controlled', 'description': 'The extraction socket will not receive a collagen sponge', 'interventionNames': ['Other: No collagen sponge application after surgical extraction of impacted 3rd molar']}, {'type': 'EXPERIMENTAL', 'label': 'Collagen', 'description': 'The extraction socket will receive a collagen sponge', 'interventionNames': ['Other: Application of a collagen sponge after surgical extraction of impacted 3rd molar']}], 'interventions': [{'name': 'Application of a collagen sponge after surgical extraction of impacted 3rd molar', 'type': 'OTHER', 'description': 'Application of a collagen sponge after surgical extraction of impacted 3rd molar', 'armGroupLabels': ['Collagen']}, {'name': 'No collagen sponge application after surgical extraction of impacted 3rd molar', 'type': 'OTHER', 'description': 'No collagen sponge application after surgical extraction of impacted 3rd molar', 'armGroupLabels': ['Controlled']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11681', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'RiyadH Colleges of dentistry and Pharmacy', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Nedal A Abu-Mostafa, Assistant P', 'role': 'CONTACT', 'email': 'nabumostafa@gmail.com', 'phone': '00966506275782'}], 'overallOfficials': [{'name': 'Nedal A Abu-Mostafa, Assistant P', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'nabumostafa@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It will be available in the published manuscript'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Colleges of Dentistry and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Oral and Maxillofacial Surgery', 'investigatorFullName': 'Nedal Abu-Mostafa', 'investigatorAffiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}}}}