Nctid:
NCT06233188
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008310", "term"=>"Malocclusion"}, {"id"=>"D000024343", "term"=>"Open Bite"}], "ancestors"=>[{"id"=>"D000014076", "term"=>"Tooth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M9556", "name"=>"Hemorrhage", "relevance"=>"LOW"}, {"id"=>"M26370", "name"=>"Fractures, Bone", "relevance"=>"LOW"}, {"id"=>"M11301", "name"=>"Malocclusion", "asFound"=>"Malocclusion", "relevance"=>"HIGH"}, {"id"=>"M22951", "name"=>"Open Bite", "asFound"=>"Open Bite", "relevance"=>"HIGH"}, {"id"=>"M16831", "name"=>"Tooth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>43}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-05-03", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-12-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-10", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-10-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"lateral nasal wall separation", "timeFrame"=>"1 year", "description"=>"The primary outcome variable is lateral nasal wall separation:\n\nType 1 Separation from the osteotomy line\n\nType 2 Separation 2-4 mm above the osteotomy line\n\nType 3 Separation 4 mm or more above the osteotomy line"}], "secondaryOutcomes"=>[{"measure"=>"pterygomaxillary junction separation", "timeFrame"=>"1 year", "description"=>"The secondary outcome variable is pterygomaxillary separation\n\nType 1 Separation including the tuber maxilla\n\nType 2 Separation from the pterygomaxillary junction\n\nType 3 Separation including the pterygoid plates"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["orthognatic surgery", "le fort I", "arterial bleeding", "down fracture", "lateral nasal wall", "pterygomaxillary junction"], "conditions"=>["Malocclusion", "Open Bite", "Le Fort; I", "Orthognathic Surgery"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture.\n\nParticipants will be divided into two treatment groups. In study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas.\n\nResearchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture.", "detailedDescription"=>"The same surgical team performed the osteotomies under general anesthesia with nasotracheal intubation. Hypotensive anesthesia was applied as a standard protocol in all patients. Orthognathic surgery, including Le Fort I and sagittal split ramus osteotomy, was used to correct skeletal deformities.\n\nBone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevation.Lateral nasal osteotomy (LNO) with Nievert Anderson single guarded osteotome, median septum separation with double guarded U-shaped osteotome, and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture. The only difference between the conventional and study groups was the depth of the LNO. In the study group, LNO was performed at a depth of 2 mm less than the measured distance in the axial section. In the conventional osteotomy group, LNO was performed at 30 mm for females and 35 mm for males, as suggested in the literature. A curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction. The down-fracture of the maxilla was performed using a hook and a bone spreader in all patients. When the maxilla was down-fractured, LNW and the pterygomaxillary separation types were assessed intraoperatively. The maxilla was stabilized in its new position by four L-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria: The inclusion criteria\n\n* orthognathic surgery to treat malocclusion\n* sleep apnea\n* jaw asymmetry\n\nExclusion Criteria:\n\n* cleft lip and palate\n* previous orthognathic surgery\n* rhinoplasty"}, "identificationModule"=>{"nctId"=>"NCT06233188", "briefTitle"=>"Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture", "organization"=>{"class"=>"OTHER", "fullName"=>"Bezmialem Vakif University"}, "officialTitle"=>"Does the Patient-specific Depth of the Lateral Nasal Wall Osteotomy Affect the Pterygomaxillary Separation During le Fort I Down-fracture?", "orgStudyIdInfo"=>{"id"=>"2023-E.110541"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"study group", "description"=>"In the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section", "interventionNames"=>["Procedure: orthogantic surgery"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"conventional group", "description"=>"n the conventional osteotomy group, lateral nasal osteotomy was performed 25 mm for female and 30 mm for male patients, as suggested in the literature.", "interventionNames"=>["Procedure: orthogantic surgery"]}], "interventions"=>[{"name"=>"orthogantic surgery", "type"=>"PROCEDURE", "description"=>"surgery that correcting the maxilla and mandible related with each other", "armGroupLabels"=>["conventional group", "study group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34093", "city"=>"Istanbul", "state"=>"Fatih", "country"=>"Turkey", "facility"=>"Taha Pergel", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Bezmialem Vakif University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Profesor", "investigatorFullName"=>"Taha Pergel", "investigatorAffiliation"=>"Bezmialem Vakif University"}}}}
