Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT06020157
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Simple and Continuous Suture Techniques in Oral Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2023-08-25', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Wound Healing Score-1', 'timeFrame': 'Day 1', 'description': 'Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)'}, {'measure': 'Early Wound Healing Score-3', 'timeFrame': 'Day 3', 'description': 'Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)'}, {'measure': 'Early Wound Healing Score-7', 'timeFrame': 'Day 7', 'description': 'Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)'}, {'measure': 'Suturing Time', 'timeFrame': '1 minutes after ending suture', 'description': 'The time between start and end of suture'}, {'measure': 'Pain at Suture Removal', 'timeFrame': 'Day 7', 'description': 'VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.'}, {'measure': 'Suture Removal Difficulty', 'timeFrame': 'Day 7', 'description': 'VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Heal']}, 'descriptionModule': {'briefSummary': 'The study aims to compare two different suture techniques regarding wound healing. In this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. For this purpose, Selçuk University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap opened (for alveoplasty). Half of the arch will be closed by a simple suture. The other half will be closed by continuous suture technique.\n\nIt is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day when the sutures will be removed. On the 7th day, it is planned to evaluate the suture removal pain for the patient and the ease of suture removal for the operator with the VAS scale. Data collected from these assessments will be statistically compared for simple and continuous sutures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Needing full arch alveoplasty\n* No smoking\n\nExclusion Criteria:\n\n* Uncontrolled systemic condition\n* Not participating in control appointments\n* Complications about wound healing'}, 'identificationModule': {'nctId': 'NCT06020157', 'briefTitle': 'Comparison of Simple and Continuous Suture Techniques in Oral Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Comparison of Simple and Continuous Suture Techniques in Oral Surgery Regarding Wound Healing, a Split-Mouth Clinical Trial', 'orgStudyIdInfo': {'id': 'Selcuk003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simple Suture Group', 'interventionNames': ['Other: Simple Suture Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous Suture Group', 'interventionNames': ['Other: Continuous Suture Technique']}], 'interventions': [{'name': 'Simple Suture Technique', 'type': 'OTHER', 'description': 'The half of the full arch flap will be closed by the simple suture technique.', 'armGroupLabels': ['Simple Suture Group']}, {'name': 'Continuous Suture Technique', 'type': 'OTHER', 'description': 'The half of the full arch flap will be closed by the continuous suture technique.', 'armGroupLabels': ['Continuous Suture Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'state': 'Selçuklu', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University, Dentistry Faculty', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Şeyma Koyuncu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Selcuk University, Faculty of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gokhan Gurses', 'investigatorAffiliation': 'Selcuk University'}}}}