Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT07118605
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimally Invasive Sagittal Split Ramus Osteotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'Intraoperative period (from skin incision to final suture placement)', 'description': 'Operative time will be measured in minutes, separately for the right and left sides, from the initial skin incision to the final suture placement, using a chronometer.'}, {'measure': 'Bleeding', 'timeFrame': 'Intraoperative period (from skin incision to final suture placement)', 'description': 'Bleeding volume will be measured in milliliters from the initial skin incision to the final suture placement, using separate calibrated aspirators for the left and right sides.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Edema', 'timeFrame': 'Postoperative days 1, 7, 14, and 30', 'description': 'The 3dMD imaging system (3dMD, Atlanta, GA) and 3dMD Vultus software were used to evaluate the amount of postoperative edema. Three-dimensional images were taken with the teeth in maximum intercuspation, lips relaxed, and eyes open on postoperative days 1, 7, 14, 30, and 90. Edema was calculated separately for the right and left sides and was recorded as surface area in square centimeters (cm²).'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative hours 1, 2, 4, 6, 8, 10, and 12', 'description': "Postoperative pain was evaluated using the Visual Analogue Scale for the right and left sides separately. In this scale, '0' meant no pain, and '100' represented maximum pain. Patients were questioned at postoperative 1st, 2nd, 4th, 6th, 8th, 10th, and 12th hours, and the results were recorded in the patient follow-up form."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['minimally invasive', 'sagittal split ramus osteotomy', 'orthognathic surgery', 'patient outcomes'], 'conditions': ['Orthognathic Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University.\n\nEach patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling.\n\nThis study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity\n* Patients classified as ASA I or II\n* Patients over 18 years of age\n\nExclusion Criteria:\n\n* Patients with uncontrolled diabetes\n* Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease)\n* Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome)\n* Patients who had previously undergone mandibular surgery due to trauma, tumors, or cysts and had sequelae involving the lower jaw"}, 'identificationModule': {'nctId': 'NCT07118605', 'briefTitle': 'Minimally Invasive Sagittal Split Ramus Osteotomy', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Exploring the Potential of Minimally Invasive Sagittal Split Ramus Osteotomy to Transform Patient Outcomes: A Randomized, Double-Blind, Controlled Split Mouth Study', 'orgStudyIdInfo': {'id': '2024/110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally Invasive Sagittal Split Ramus Osteotomy', 'interventionNames': ['Procedure: Minimally Invasive Sagittal Split Ramus Osteotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Sagittal Split Ramus Osteotomy', 'interventionNames': ['Procedure: Conventional Sagittal Split Ramus Osteotomy']}], 'interventions': [{'name': 'Minimally Invasive Sagittal Split Ramus Osteotomy', 'type': 'PROCEDURE', 'description': 'This procedure involves a limited mucosal incision and tunnel dissection technique combined with low and short osteotomy and minimal soft tissue manipulation. The goal is to reduce surgical trauma, edema, blood loss, and operative time while maintaining clinical effectiveness.', 'armGroupLabels': ['Minimally Invasive Sagittal Split Ramus Osteotomy']}, {'name': 'Conventional Sagittal Split Ramus Osteotomy', 'type': 'PROCEDURE', 'description': 'This procedure follows the traditional wide exposure technique with full-thickness mucoperiosteal flap elevation. This method is widely accepted and serves as the control for comparison.', 'armGroupLabels': ['Conventional Sagittal Split Ramus Osteotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'İbrahim Mert Erkan', 'investigatorAffiliation': 'TC Erciyes University'}}}}