Nctid:
NCT06231290
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "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"=>68}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2025-07", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-13", "studyFirstSubmitDate"=>"2024-01-20", "studyFirstSubmitQcDate"=>"2024-01-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-14", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Clinical and radiographic outcome", "timeFrame"=>"Immediately, 1, 3, 6 and 12 months.", "description"=>"The clinical outcome will be measured by the presence or absence of signs and symptoms. The radiographic outcome will be measured by using the PAI index which is a scale from 1 (best) to 5 (worst)."}], "secondaryOutcomes"=>[{"measure"=>"Postoperative pain", "timeFrame"=>"Immediately, 24, 48, 72 hours and 7 days", "description"=>"The postoperative pain will be measured by the modified Verbal Descriptor Scale which is a scale from 0 (best) to 10 (worst)."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Pulpotomy", "Magnification", "Clinical experience", "Irreversible pulpitis"], "conditions"=>["Irreversible Pulpitis"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this interventional randomized clinical trial is to test the effect of magnification and clinical experience of the operator on the success rate of full pulpotomy in mature adult molar teeth.\n\nThe main questions it aims to answer are:\n\n* Does the use of magnification raise the success rate of full pulpotomy of mature adult molars?\n* Does the clinical experience of the operator dentist raise the success rate of full pulpotomy of mature adult molars?\n\nParticipants will be asked to do the following:\n\n* Receive the pulpotomy treatment of their target molar tooth.\n* Record the pain score in the pain assessment chart.\n* Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target molar tooth. Researchers will evaluate the usage of magnification in performing the pulpotomy procedure of adult molar teeth by postgraduate or undergraduate operators in comparison to performing the same pulpotomy procedure without magnification to see if it raises the overall success rate of pulpotomy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"40 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Healthy patients diagnosed with acute irreversible pulpitis related to maxillary or mandibular permanent molar teeth without apical periodontitis.\n\nExclusion Criteria:\n\n* Non-vital teeth.\n* Immature teeth.\n* Presence of swelling or sinus tract.\n* Teeth with mobility grade II or III.\n* Immunocompromised patients.\n* Non-restorable teeth.\n* Teeth with apical periodontitis seen in periapical radiograph.\n* Periodontally affected teeth.\n* Teeth with reversible pulpitis\n* Extensive non-stoppable bleeding more than 6 minutes\n* Teeth with partial necrosis"}, "identificationModule"=>{"nctId"=>"NCT06231290", "briefTitle"=>"The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth", "organization"=>{"class"=>"OTHER", "fullName"=>"Al-Azhar University"}, "officialTitle"=>"The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth: A Randomized Clinical Trial", "orgStudyIdInfo"=>{"id"=>"874/3036"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Postgraduate operator with magnification", "interventionNames"=>["Other: Adult full pulpotomy procedure"]}, {"type"=>"EXPERIMENTAL", "label"=>"Postgraduate operator without magnification", "interventionNames"=>["Other: Adult full pulpotomy procedure"]}, {"type"=>"EXPERIMENTAL", "label"=>"Undergraduate operator with magnification", "interventionNames"=>["Other: Adult full pulpotomy procedure"]}, {"type"=>"EXPERIMENTAL", "label"=>"Undergraduate operator without magnification", "interventionNames"=>["Other: Adult full pulpotomy procedure"]}], "interventions"=>[{"name"=>"Adult full pulpotomy procedure", "type"=>"OTHER", "description"=>"The adult pulpotomy procedure of mature molars will be carried out with the use of magnification (dental loupes or microscope) in healthy patients. The procedure will be performed either by postgraduate or undergraduate operators.", "armGroupLabels"=>["Postgraduate operator with magnification", "Postgraduate operator without magnification", "Undergraduate operator with magnification", "Undergraduate operator without magnification"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11751", "city"=>"Cairo", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Moataz A Alkhawas, Professor", "role"=>"CONTACT", "email"=>"moataz-bellahalkhawas.209@azhar.edu.eg", "phone"=>"+201001189085"}], "facility"=>"Faculty of Dental Medicine, Al-Azhar University", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "centralContacts"=>[{"name"=>"Mohamed A. Yahia, BSc", "role"=>"CONTACT", "email"=>"mohamed.de2016@gmail.com", "phone"=>"+201273892231"}, {"name"=>"motaz M. Elsadat, PhD", "role"=>"CONTACT", "email"=>"motazelsadat@azhar.edu.eg", "phone"=>"+201064808605"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Al-Azhar University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Postgraduate student", "investigatorFullName"=>"Mohamed Ahmed Mohamed Yahia", "investigatorAffiliation"=>"Al-Azhar University"}}}}
