Nctid:
NCT06221527
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D050723", "term"=>"Fractures, Bone"}], "ancestors"=>[{"id"=>"D014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M26370", "name"=>"Fractures, Bone", "asFound"=>"Fracture", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D006820", "term"=>"Hyaluronic Acid"}], "ancestors"=>[{"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D055675", "term"=>"Viscosupplements"}, {"id"=>"D020011", "term"=>"Protective Agents"}], "browseLeaves"=>[{"id"=>"M9878", "name"=>"Hyaluronic Acid", "asFound"=>"12 hours", "relevance"=>"HIGH"}, {"id"=>"M8896", "name"=>"Gelatin Sponge, Absorbable", "relevance"=>"LOW"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M28295", "name"=>"Viscosupplements", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Coagulants", "abbrev"=>"Coag"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Double(Participant, Outcome Assessor)"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"comparison between healing properties using hyaluronic acid topical application and not using it in parasymphyseal fracture"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>22}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"BV\\TV (Bone Volume Fraction ) (%)", "timeFrame"=>"immediate postoperative and four months intervals", "description"=>"Radiographically(CBCT) through percent (%)"}, {"measure"=>"Pain(VAS)", "timeFrame"=>"at one week and three months intervals", "description"=>"Questionnaire through VAS"}, {"measure"=>"Wound dehiscence(Binary)", "timeFrame"=>"at one week and three months intervals", "description"=>"Clinically through binary"}], "primaryOutcomes"=>[{"measure"=>"Patient satisfaction(score)", "timeFrame"=>"at one week and three months intervals", "description"=>"Patient satisfaction survey through score"}], "secondaryOutcomes"=>[{"measure"=>"Fracture gap distance(mm)", "timeFrame"=>"immediate postoperative and four months intervals", "description"=>"Radiographically(CBCT) through millimeter"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["parasymphyseal fracture", "hyaluronic acid"], "conditions"=>["Maxillofacial Trauma"]}, "descriptionModule"=>{"briefSummary"=>"HA is favorable for osteogenesis, enhancing bone growth, acting a vector for osteoinductive compounds and promoting even distribution and increased density of newly formed bone, thereby altering the scaffold morphology and improving mineralization. In this study 22 volunteers will be included in this study, the volunteers will be randomly distributed into two groups each containing 11 volunteers, one group will be treated by hyaluronic acid before fixation and the other group will be treated by fixation only without placement of hyaluronic acid, to compensate for drop out 13 volunteers per group", "detailedDescription"=>"Patients of both groups will be subjected to:\n\n1. Clinical assessment including case history including personal data,medical,surgical history and family history\n2. Radiographic assessment includes preoperative digital panomora to evaluate fracture and to conclude presence or absence of any foreign body or pathological pathosis.\n3. Signing the informed consent will be done after explaining surgical procedure. All the patients will be nasally intubated, scrubbed and draped in the standard manner, followed by intra-oral and extra-oral povidone-iodine (Betadine)swabbing.\n\nLocal anesthesia containing vasoconstrictor will be injected in the vestibule Incision at lower anteriors will be done in the mucosa in a curvilinear fashion 10-15mm away from the attached gingiva, the incision distal to the canine will be 5 mm from the attached gingival to be superior to the mental nerve.\n\nSubmucosal dissection will be done to expose the mentalis muscle, followed by mucoperiosteal flap elevation till inferior border exposing the fracture line.\n\nThe fracture segments will be reduced after curettage and removal of any debris.\n\nMMF will be done to ensure proper occlusion. Two four-hole titanium miniplates will be placed on inferior border and another one on superior border.\n\nFor the intervention group: placement of hyaluronic acid paste will be carried over gel foam and placed between fractured segments before plate fixation.\n\nFor the control group: no hyaluronic acid paste will be applied during fixation only gel foam between fractures segments without any additives.\n\nSuturing using 4-0 resorbable sutures will take place after MMF release in layers, anteriorly mentalis muscle will be closed first to prevent chin drooping followed by a continuous running closure of mucosa.\n\nElastic dressing will be applied over chin region supporting the soft tissues and preventing hematoma formation.\n\nPost-operative care:\n\nAvoid traumatization of the surgical site. All patients will be instructed to apply ice packs over submental area for 15 minutes per hour for 24 hours postoperatively.\n\nAll patients will be given postoperative medication as follows:\n\nAnti-inflammatory drug diclofenac potassium (Cataflam50mg)2tabletsevery8hoursforaweek to relieve pain Antibiotic drug Amoxicillin/clavulanic acid tablets (Hibiotic 1gm)1gm every 12 hours for 7 days\n\n-Benzethonium Chloride (Antiseptol mouthwash), starting from the day after the surgery 3 times daily for 10 days.\n\nInstruct the patient not to touch or manipulate the surgical area. No consumption of tobacco for one week postoperatively."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"16 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with unilateral Para symphyseal fracture\n* Systemically healthy patients (American Society of Anesthesiologists -ASA I and II)\n* Age of the patient above 16 years to 60 years old\n* Patient of both sexes\n* Patients willing for the surgical procedure and follow up with an informed consent.\n\nExclusion Criteria:\n\n* Bad oral hygiene\n* smokers (\\>10cigarettes/day)\n* Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism\n* Radiotherapy or chemotherapy form malignancy\n* Patients who refused to sign consent form"}, "identificationModule"=>{"nctId"=>"NCT06221527", "briefTitle"=>"Assessment of Healing Properties Using Hyaluronic Acid Topical Application in Parasymphyseal Fracture Fixation: A Randomized Clinical Trial", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Assessment of Healing Properties Using Hyaluronic Acid Topical Application in Parasymphyseal Fracture Fixation: A Randomized Clinical Trial", "orgStudyIdInfo"=>{"id"=>"Omfs 3 3 16"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"conventional group", "description"=>"fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border.", "interventionNames"=>["Procedure: conventional group"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"study group", "description"=>"placement of hyaluronic acid will be carried over gel foam and placed between fractured segments before plate fixation.\n\nfixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border.", "interventionNames"=>["Procedure: conventional group"]}], "interventions"=>[{"name"=>"conventional group", "type"=>"PROCEDURE", "otherNames"=>["study group,- Placement of hyaluronic acid paste will be carried over gel foam and placed between fractured segments of parasymphysial before plate fixation"], "description"=>"fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border", "armGroupLabels"=>["conventional group", "study group"]}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"principal investigator", "investigatorFullName"=>"aisha khaled mansour", "investigatorAffiliation"=>"Cairo University"}}}}
