Nctid:
NCT06613932
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011671", "term"=>"Pulpitis"}], "ancestors"=>[{"id"=>"D000003788", "term"=>"Dental Pulp Diseases"}, {"id"=>"D000014076", "term"=>"Tooth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M14525", "name"=>"Pulpitis", "asFound"=>"Pulpitis", "relevance"=>"HIGH"}, {"id"=>"M6984", "name"=>"Dental Pulp Diseases", "relevance"=>"LOW"}, {"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"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>45}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-10-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-10-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-08-16", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"post operative Pain assessment", "timeFrame"=>"6, 12, 24, 72hours and 7 days after treatment", "description"=>"Pain evaluations were conducted preoperatively with numerical rating scale ( a verbal or writing determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain ."}], "secondaryOutcomes"=>[{"measure"=>"Dentine bridge formation", "timeFrame"=>"12 months post operative", "description"=>"evaluating the thickness of dentine bridge formed after the procedure by comparing immediate post operative CBCT with the one year follow up scans"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Irreversible Pulpitis"]}, "descriptionModule"=>{"briefSummary"=>"Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.", "detailedDescription"=>"pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"30 years", "minimumAge"=>"15 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion criteria:\n\nPatients should be free from any systemic disease. Patients of either gender aged from 15-30. Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn\\'t contain any internal or external resorption or periapical lesions.\n\nThe tooth should give a positive response to the cold test.\n\nExclusion criteria:\n\nPregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy"}, "identificationModule"=>{"nctId"=>"NCT06613932", "briefTitle"=>"Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Using Pulpotomy in Mature Mandibular First Molars", "organization"=>{"class"=>"OTHER", "fullName"=>"Future University in Egypt"}, "officialTitle"=>"Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Material Combined With L-PRF Scaffold in Vital Pulp Therapy. Treatments in Mandibular First Molars With Closed Apices \"Randomized Controlled Trial\"", "orgStudyIdInfo"=>{"id"=>"(37)11-2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"hydroxyapatite", "description"=>"using hydroxyapatite as a pulpotomy agent and reviewing its clinical and radiographic performance compared to the other groups", "interventionNames"=>["Procedure: pulpotomy"]}, {"type"=>"EXPERIMENTAL", "label"=>"L-PRF", "description"=>"using L-PRF as a pulpotomy agent and assessing the clinical and radiographic result compared to other groups", "interventionNames"=>["Procedure: pulpotomy"]}, {"type"=>"EXPERIMENTAL", "label"=>"L-PRF combined with Nano-hydroxyapatite", "description"=>"using the combined material (nanohydroxyapatite mixed to L-PRF ) and assessing the clinical and radiographic result compared to other groups", "interventionNames"=>["Procedure: pulpotomy"]}], "interventions"=>[{"name"=>"pulpotomy", "type"=>"PROCEDURE", "otherNames"=>["vital pulp therapy"], "description"=>"removal of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure", "armGroupLabels"=>["L-PRF", "L-PRF combined with Nano-hydroxyapatite", "hydroxyapatite"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11835", "city"=>"Cairo", "state"=>"New Cairo", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"nada A metwally, master", "role"=>"CONTACT", "email"=>"nadaaymaan55@gmail.com", "phone"=>"01122289353", "phoneExt"=>"+02"}], "facility"=>"future university in Egypt", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "centralContacts"=>[{"name"=>"nada A metwally, master", "role"=>"CONTACT", "email"=>"nadaaymaan55@gmail.com", "phone"=>"01122289353", "phoneExt"=>"+02"}, {"name"=>"toka A metwally, bachelor's", "role"=>"CONTACT", "phone"=>"01068681660", "phoneExt"=>"+02"}], "overallOfficials"=>[{"name"=>"wael K hussein, professor", "role"=>"STUDY_DIRECTOR", "affiliation"=>"future"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Future University in Egypt", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"principal investigator", "investigatorFullName"=>"Nada Ayman El-Sayed Ibraim", "investigatorAffiliation"=>"Future University in Egypt"}}}}
