Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 12:53 PM
Study NCT ID:
NCT06864559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013515', 'term': 'Surgery, Oral'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-02-22', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial colonization', 'timeFrame': '7 days.', 'description': 'Microbiological analysis: CFU and qPCR bacterial count.'}, {'measure': 'Level of inflammation', 'timeFrame': '7 days.', 'description': 'The degree of soft tissue inflammation was assessed using Visual Analogue Scale (VAS).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Healing Complication', 'Oral Surgery', 'Third Molar Extraction', 'Oral Infection']}, 'descriptionModule': {'briefSummary': 'Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).', 'detailedDescription': "The general or primary objective is:\n\n• To compare 3 non-absorbable suture materials used in oral surgery: silk, polyamide monofilament and expanded polytetrafluoroethylene.\n\nThe specific or secondary objectives are:\n\n* To evaluate how each type of suture influences wound healing and the patient's postoperative period.\n* To study bacterial colonization in each type of suture.\n* To determine the tissue reaction and clinical characteristics of each suture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with indication for extraction of a third lower molar retained in an unfavorable position that requires a bayonet incision in the surgical procedure.\n* Age: patients aged 18 years or older.\n* ASA I patients (Classification of the American Society of Anesthesiology, 1979): healthy patients who tolerate stress well, without systemic pathology, no anxiety and in whom a therapeutic modification is not necessary.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Smoking patients.'}, 'identificationModule': {'nctId': 'NCT06864559', 'briefTitle': 'Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study', 'orgStudyIdInfo': {'id': '2028/CEIH/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Suture 1: Silk.', 'description': 'Silk suture.', 'interventionNames': ['Other: To Compare 3 different suture materials used in oral surgery']}, {'type': 'OTHER', 'label': 'Suture 2: Non-absorbable polyamide monofilament.', 'description': 'Non-absorbable polyamide monofilament.', 'interventionNames': ['Other: To Compare 3 different suture materials used in oral surgery']}, {'type': 'OTHER', 'label': 'Suture 3: Non-resorbable expanded polytetrafluoroethylene.', 'description': 'Non-resorbable expanded polytetrafluoroethylene.', 'interventionNames': ['Other: To Compare 3 different suture materials used in oral surgery']}], 'interventions': [{'name': 'To Compare 3 different suture materials used in oral surgery', 'type': 'OTHER', 'otherNames': ['2028/CEIH/2021'], 'description': 'To compare bacterial colonization, tissue reaction and clinical characteristics such as wound healing and patient postoperative outcomes in 3 different suture materials used in oral surgery.', 'armGroupLabels': ['Suture 1: Silk.', 'Suture 2: Non-absorbable polyamide monofilament.', 'Suture 3: Non-resorbable expanded polytetrafluoroethylene.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS (University of Granada), MSc (Oral Surgery)', 'investigatorFullName': 'Jose Manuel Alarcón Cordovilla', 'investigatorAffiliation': 'Universidad de Granada'}}}}