[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560208":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":49,"responsibleParty":69,"collaborators":27,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":27,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":27,"enrollmentInfo":80,"targetDuration":27,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":95,"overallStatus":52,"whyStopped":27,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"EMS and PBM treatment","EXPERIMENTAL","Photobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 25 seconds with an energy density of 10 J\u002Fcm2 (irradiation mode).",[13,14],"Device: PBM treatment","Device: EMS",{"label":16,"type":17,"description":18,"interventionNames":19},"EMS and PBM sham treatment","SHAM_COMPARATOR","The laser tip will be placed following the outline of the incision flap in a contact mode but without activating it (no irradiation).",[20,14],"Device: PBM sham treatment",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","PBM treatment","Immediately after the apical microsurgery, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA), with an 8 mm tip diameter . The laser tip will be placed following the outline of the incision flap in a contact mode . The power output of the laser will be 50 milliwatt (mW) and verified by a Power Meter (PM600 Power\u002FEnergy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J\u002Fcm2",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"PBM sham treatment","Immediately after the apical microsurgery, sham therapy will be performed without activating the laser.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"EMS","Patients will be anesthetized. All surgeries will be performed using a surgical microscope. After reflection of a mucoperiosteal flap, osteotomies will be performed to access the root apices and apical lesions. Root apices will be resected at 3 mm, and the pathological tissue curetted out. Next, root-end preparations will be made with ultrasonic tips and filled with calcium silicate-based materials. Methylene blue dye will be used for inspection after root-end resection before the root-end preparation and filling. After cleaning the osseous crypt, the wound margins will be reapproximated with 5-0 single interrupted sutures. A gauze will be placed for 30 minutes for wound compression. Sutures will be removed seven days postoperatively",[16,9],[37],{"name":38,"affiliation":5,"role":39},"Juliana Barros, DDS,MS","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":44},"CONTACT","(713) 486-4564","Juliana.Barros@uth.tmc.edu",{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},"Kala Morales","713-486-4229","Kala.D.MoralesLadrondeGuevara@uth.tmc.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-95.36327,29.76328,{"lat":62,"lon":61},[65,68],{"name":66,"role":42,"phone":67,"phoneExt":27,"email":44},"Juliana Barros, DDS, MS","713-486-4564",{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},{"type":39,"investigatorFullName":66,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Professor","100560208","effect-of-photobiomodulation-on-pain-and-healing-of-the-vertical-releasing-incision-after-endodontic-microsurgery-100560208",false,"NCT06574152","Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery","Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I or II.\n* At least one tooth will receive EMS.\n* Flap design that includes at least one VRI (triangular, rectangular, papilla base or submarginal rectangular).\n\nExclusion Criteria:\n\n* ASA III or IV.\n* Current heavy smokers (\\>10 cigarettes\u002Fday)\n* Uncontrolled diabetes (HbA1c ≥ 7%) or other uncontrolled systemic diseases that may comprise healing, such as vitamin C deficiency, neutrophil deficiencies, immunodeficiency syndromes, or leukemia.\n* Surgical access on the palatal surface.\n* Acute swelling or abscess present on the day of the surgery.\n* Any event or condition that would make continued participation in the study not in the best interest of the subject, as determined by the investigator.\n* Pregnancy.\n* Development of any medical condition that might affect the treatment and clinical outcomes, as determined by the investigator.\n* Initiation of any treatment or exposure that might affect therapy's healing, as determined by the investigator.","ALL","18 Years",{"count":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[85],"NA","The purpose of this study is to evaluate the effect of Photobiomodulation (PBM) in postoperative pain after endodontic microsurgery (EMS) in patients from the University of Texas Health Science Center at Houston, School of Dentistry Graduate Endodontic Clinic and to assess the soft tissue healing of the vertical releasing incision (VRI) after PBM",[88,89,90,91,92,93,94],"Apical Periodontitis","Endodontically Treated Teeth","Endodontic Disease","Apical Cyst","Apical Granuloma","Periradicular Disease","Previous Endodontic Treatment",[96,97,98,99,100],"vertical incision","photobiomodulation","apicoectomy","endodontic microsurgery","laser therapy","2024-08-27",{"date":103,"type":104},"2024-08-29","ACTUAL",{"date":106,"type":104},"2024-08-20",{"date":108,"type":82},"2025-07-31",{"name":5,"class":6},1]