Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-10 @ 6:18 PM
Study NCT ID:
NCT03270618
Status:
UNKNOWN
Last Update Posted:
2017-09-01
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of a CAD/CAM Surgical Template for Mandible Distraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005146', 'term': 'Facial Asymmetry'}, {'id': 'D000070631', 'term': 'Diastasis, Bone'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linear differences of the distractor position', 'timeFrame': 'within latency period (5-7 days after the surgery)'}, {'measure': 'angular differences of the distractor vector', 'timeFrame': 'within latency period (5-7 days after the surgery)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Facial Asymmetry', 'Mandible; Hypoplasia, Unilateral Condylar', 'Distraction of Bone']}, 'descriptionModule': {'briefSummary': 'The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Distraction was simulated on virtual model and the new morphology of the mandible was predicted. The position and direction of the distractor was determined to achieve the optimal morphology. The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. The outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. Linear and angular differences for the distractor was measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were scheduled to undergo mandibular DO via intraoral approach\n* Patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment\n* Patients who agreed to participate in this study\n\nExclusion Criteria:\n\n* Patients requiring more than one distractor of the mandible\n* Patients with mandible defect\n* Patients with previous mandibular trauma'}, 'identificationModule': {'nctId': 'NCT03270618', 'briefTitle': 'Accuracy of a CAD/CAM Surgical Template for Mandible Distraction', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction', 'orgStudyIdInfo': {'id': 'cmfs02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CAD/CAM Surgical Template', 'type': 'DEVICE', 'description': 'The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Biao Li, Master', 'role': 'CONTACT'}], 'facility': "Ninth People's Hospital, Shanghai Jiaotong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Biao Li, Master', 'role': 'CONTACT', 'email': 'benleex@foxmail.com', 'phone': '15900561183'}], 'overallOfficials': [{'name': 'Xudong Wang', 'role': 'STUDY_CHAIR', 'affiliation': "Ninth People's Hospital, Shanghai Jiaotong University School of Medicine"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Oral and Craniomaxillofacial Surgery', 'investigatorFullName': 'Xudong Wang', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}