[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433292":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":62,"collaborators":42,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":42,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":42,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":86,"whyStopped":42,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Root canal treatment (RCT)","ACTIVE_COMPARATOR","For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols",[13],"Procedure: RCT",{"label":15,"type":16,"description":17,"interventionNames":18},"Pulpotomy","EXPERIMENTAL","Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here.",[19],"Procedure: Pulpotomy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","RCT","This is the standard of care for this diagnosis",[9],[27],"Endodontic therapy",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"For cases with normal apical tissues, pulpotomy using tricalcium silicates has been shown to have high clinical success. Either partial or complete pulpotomy will be performed depending on the size of pulp exposure.",[15],[32],"Therapeutic pulpotomy",[34],{"name":35,"affiliation":5,"role":36},"Ashraf Fouad, DDS","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Sheila Turner, DDS","CONTACT","(205) 934-5045",null,"jordan@uab.edu",[45],{"facility":46,"status":42,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"School of Dentistry, University of Alabama at Birmingham","Birmingham","Alabama","35233","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-86.80249,33.52066,{"lat":56,"lon":55},[59,61],{"name":60,"role":40,"phone":41,"phoneExt":42,"email":43},"Sheila Turner",{"name":35,"role":36,"phone":42,"phoneExt":42,"email":42},{"type":36,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Ashraf Fouad","Professor and Chair","100433292","comparative-effectiveness-in-the-management-of-irreversible-pulpitis-100433292",false,"NCT04922229","Comparative Effectiveness in the Management of Irreversible Pulpitis","Inclusion Criteria:\n\n* Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia \\>30 seconds), and normal apical tissues.\n* Tooth is responsive to cold and electrical pulp testing.\n* Patients aged ≥12 years for first molars and ≥16 years for second molars.\n\nExclusion Criteria:\n\n* Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site\n* Teeth that are badly broken down and\u002For are not restorable.\n* Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral side.\n* Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration.\n* Radiographic evidence of PDL space wider than three times normal width\n* Clinical evidence of swelling or sinus tract\n* Periodontal pocket probing depth ≥5 mm in any site around the tooth.\n* Clinical evidence of cracks connecting mesial and distal surfaces and\u002For extending in pulp chamber or associated with periodontal pockets ≥ 5 mm.\n* History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and\u002For modify pain experience, within the previous 6 months.\n* Use of medications that affect the host response such as methotrexate, corticosteroids or cyclosporin.\n* Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications.\n* Patients who require IV sedation or general anesthesia for their dental treatment.\n* Teeth with full coverage crowns.\n* Teeth undergoing active orthodontic movement.\n* Teeth that require elective RCTx to place a post for restorative purposes.\n* Teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls.\n* Teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.",true,"ALL","12 Years","99 Years",{"count":76,"type":77},138,"ESTIMATED","INTERVENTIONAL",[80],"NA","This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.",[83],"Irreversible Pulpitis",[15,85],"Vital Pulp Therapy","NOT_YET_RECRUITING","2026-02-12",{"date":89,"type":90},"2026-02-17","ACTUAL",{"date":92,"type":77},"2027-06-01",{"date":94,"type":77},"2031-12-31",{"name":5,"class":6},1]