Nctid:
NCT06235138
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008310", "term"=>"Malocclusion"}], "ancestors"=>[{"id"=>"D014076", "term"=>"Tooth Diseases"}, {"id"=>"D009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M11301", "name"=>"Malocclusion", "asFound"=>"Malocclusion", "relevance"=>"HIGH"}, {"id"=>"M16831", "name"=>"Tooth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>20}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2017-05-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-12", "completionDateStruct"=>{"date"=>"2023-08-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-11", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-08-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The primary outcome of interest was the postoperative aspect and position of the gonial angle", "timeFrame"=>"postoperative week 4", "description"=>"The primary outcome of interest was the postoperative aspect and position of the gonial angle, assessed by 3D-stereophotogrametry"}, {"measure"=>"Secondary outcome of interest is patients satisfaction", "timeFrame"=>"From post operative week 1 to one year follow-up", "description"=>"Scale title = échelle de Likert. Maximum score 5 (= not satisfied) / minimum score 1 (= total satisfaction)"}, {"measure"=>"Secondary outcome of interest is number and type of complications", "timeFrame"=>"From post operative week 1 to one year follow-up", "description"=>"Secondary outcome of interest is number and type of complications"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Malocclusion"]}, "descriptionModule"=>{"briefSummary"=>"Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. A few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. The advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (CAD-CAM) techniques for patient-specific implant (PSI) fabrication has enabled new methods for managing the jawline in orthognathic surgery. The aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.Methods: A virtual simulation of a Le Fort I osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3D) model of each patient's skull using ProPlan CMF software (Materialise, Leuven, Belgium). Computer-assisted osteotomy saw-and-drill guides and patient-specific implants (PSIs, titanium plates and angle implants) were produced and used during the surgery. The investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3D-photographs using the VECTRA H2 3D imagine system (Canfield Scientific, \\*\\*)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"43 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France", "eligibilityCriteria"=>"* Inclusion Criteria: patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France\n* Exclusion Criteria: None"}, "identificationModule"=>{"nctId"=>"NCT06235138", "briefTitle"=>"Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Hospitalier Universitaire de Nice"}, "officialTitle"=>"Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery", "orgStudyIdInfo"=>{"id"=>"23IUFC01"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"06000", "city"=>"Nice", "state"=>"Alpes Maritimes", "country"=>"France", "facility"=>"CHU de Nice", "geoPoint"=>{"lat"=>43.70313, "lon"=>7.26608}}, {"zip"=>"06000", "city"=>"Nice", "state"=>"Alpes Maritimes", "country"=>"France", "facility"=>"CHU NICE", "geoPoint"=>{"lat"=>43.70313, "lon"=>7.26608}}], "overallOfficials"=>[{"name"=>"Olina RIOS", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Centre Hospitalier Universitaire de Nice"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centre Hospitalier Universitaire de Nice", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
