[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569209":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":18,"centralContacts":55,"locations":64,"responsibleParty":86,"collaborators":18,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":18,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":18,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":67,"whyStopped":18,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14,19,23,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"PBM- Study 1","EXPERIMENTAL","In PBM group, the selected tooth will receive one burst of light application (20 seconds) before being subjected to sensibility testing and gingival probing.",[13],"Device: Photobiomodulation",{"label":15,"type":16,"description":17,"interventionNames":18},"no PBM - Study 1","NO_INTERVENTION","In the control (no PBM) group, the selected tooth will be subjected to sensibility testing and gingival probing without PBM.",null,{"label":20,"type":10,"description":21,"interventionNames":22},"PBM- Study 2","PBM (one burst\u002F 20 seconds application) at injection site (prior to local anesthesia infiltration)",[13],{"label":24,"type":25,"description":26,"interventionNames":27},"no PBM- Study 2","ACTIVE_COMPARATOR","Topical benzocaine at injection site (prior to local anesthesia infiltration)",[28],"Drug: Topical Benzocaine",{"label":30,"type":10,"description":31,"interventionNames":32},"PBM- Study 3","PBM (one burst\u002F 20 seconds application) followed by traditional tooth preparation with burs\u002Fhandpiece and placement of restoration. Additional bursts may be provided every 20 minutes depending on the length of the procedure and patient-reported discomfort.",[13],{"label":34,"type":25,"description":35,"interventionNames":36},"no PBM- Study 3","Topical benzocaine\u002FLocal infiltration followed by traditional tooth preparation with burs\u002Fhandpiece and placement of restoration.",[28,37],"Drug: Local Anesthesia",[39,46,51],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DEVICE","Photobiomodulation","Photomodulation (PBM) is a promising non-tissue penetrating (i.e. minimally invasive) approach for achieving tooth and soft tissue anesthesia\u002Fanalgesia in dental patients. A patent pending near-infrared laser technology that aims to provide dental analgesia will be used for PBM. This intra-oral PBM device comes with a tip comprising of a series of photonic emitters with specific wavelengths that can go through the tooth structure and bone, blocking the nerve conduction like local anesthetics. Research has shown that one burst of light application (for about 20 second) can provide up to 15-20 minutes of pain relief. Based on existing research PBM does not present a serious risk to health, safety, or welfare of a subject.",[9,20,30],[45],"Low-level light therapy, near-infrared light",{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":18},"DRUG","Topical Benzocaine","Topical Benzocaine at injection site to reduce discomfort of local infiltration",[24,34],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":18},"Local Anesthesia","Local infiltration using local anesthetics with epinephrine",[34],[56,61],{"name":57,"role":58,"phone":59,"phoneExt":18,"email":60},"Vineet Dhar, BDS, MDS, PhD","CONTACT","410-706-7970","vdhar@umaryland.edu",{"name":62,"role":58,"phone":59,"phoneExt":18,"email":63},"Kue-Ling Hsu, DDS, MS","khsu@umaryland.edu",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"University of Maryland School of Dentistry, Pediatric Clinics","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-76.61219,39.29038,{"lat":77,"lon":76},[80,83],{"name":57,"role":58,"phone":81,"phoneExt":18,"email":82},"4107067970","VDhar@umaryland.edu",{"name":84,"role":58,"phone":18,"phoneExt":18,"email":85},"Kuei Ling Hsu, DDS, MS","Khsu@umaryland.edu",{"type":87,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100569209","photobiomodulation-and-tooth-analgesia-100569209",false,"NCT06691269","Photobiomodulation and Tooth Analgesia","Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients","Inclusion Criteria:\n\n* Healthy children, aged 6-12 years, requiring routine dental treatment\n\nExclusion Criteria:\n\n* Children with uncooperative behavior or signficant medical history",true,"ALL","6 Years","12 Years",{"count":100,"type":101},200,"ESTIMATED","INTERVENTIONAL",[104],"NA","The purpose of this study is to test photobiomodulation (PBM) with a non-invasive light device for reducing discomfort during dental treatments in children. We plan to conduct a series of three clinical studies in 200 school-aged children requiring routine dental treatment. The first study aims to test if PBM works for tooth and soft tissue by assessing response to cold testing and probing of gums. The second study aims to test if use of PBM on soft tissues before injection reduces discomfort. The third study aims to test if PBM can be used to do simple dental fillings in baby teeth without numbing injection.",[107,108,109],"Dental Anaesthesia","Dental Pain","Dental Analgesia",[111,112,113],"photobiomodulation","dental analgesia","dental anesthesia","2025-07-21",{"date":116,"type":117},"2025-07-25","ACTUAL",{"date":119,"type":117},"2025-07-07",{"date":121,"type":101},"2027-06",{"name":5,"class":6},1]