[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577770":3},{"organization":4,"armGroups":7,"interventions":64,"overallOfficials":91,"centralContacts":96,"locations":102,"responsibleParty":120,"collaborators":70,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":70,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":70,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":149,"whyStopped":70,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"University of Oklahoma","OTHER",[8,15,20,24,28,33,37,41,45,51,55,60],{"label":9,"type":10,"description":11,"interventionNames":12},"1. Gel A with nanoparticles, no light.","EXPERIMENTAL","An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\\_TiO₂) will be applied for 50 minutes.",[13,14],"Device: BLEACHING GEL A","Device: 5% NF_TiO2",{"label":16,"type":10,"description":17,"interventionNames":18},"2. Gel A with nanoparticles, with light.","An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\\_TiO₂) + 405 nm violet LED light will be applied for 50 minutes after the gel is applied.",[13,14,19],"Radiation: VISIBLE LIGHT IRRADIATION",{"label":21,"type":10,"description":22,"interventionNames":23},"3. Gel A without nanoparticles, no light.","An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide will be applied for 50 minutes.",[13],{"label":25,"type":10,"description":26,"interventionNames":27},"4. Gel A without nanoparticles, with light.","An experimental Bleaching Gel composed of Carbomer 940 hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.",[13,19],{"label":29,"type":10,"description":30,"interventionNames":31},"5. Gel B with nanoparticles, no light.","Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\\_TiO₂) applied for 50 minutes.",[14,32],"Device: BLEACHING GEL B",{"label":34,"type":10,"description":35,"interventionNames":36},"6. Gel B with nanoparticles, with light.","Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 5% nanoparticles (NF\\_TiO₂) + 405 nm violet LED light applied for 50 minutes.",[14,32,19],{"label":38,"type":10,"description":39,"interventionNames":40},"7. Gel B without nanoparticles, no light.","Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide applied for 50 minutes.",[32],{"label":42,"type":10,"description":43,"interventionNames":44},"8. Gel B without nanoparticles, with light.","Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide + 405 nm violet LED light applied for 50 minutes.",[32,19],{"label":46,"type":47,"description":48,"interventionNames":49},"9. Whiteness HP 35% no light (control).","ACTIVE_COMPARATOR","Whiteness HP 35% applied for 30 minutes.",[50],"Device: Whiteness HP 35%",{"label":52,"type":47,"description":53,"interventionNames":54},"10. Whiteness HP 35% with light (control).","Whiteness HP 35% + 405 nm violet LED light applied for 30 minutes.",[19,50],{"label":56,"type":47,"description":57,"interventionNames":58},"11. Whiteness HP AutoMixx 6% no light (control)","Whiteness HP AutoMixx 6% applied for 30 minutes.",[59],"Device: Whiteness HP Automixx 6%",{"label":61,"type":47,"description":62,"interventionNames":63},"12. Whiteness HP AutoMixx 6% with light (control)","Whiteness HP 6% + 405 nm violet LED light applied for 30 minutes.",[19,59],[65,71,75,79,84,88],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"DEVICE","BLEACHING GEL A","Carbomer 940 hydrogel + 6% Hydrogen Peroxide",[9,16,21,25],null,{"type":66,"name":72,"description":73,"armGroupLabels":74,"otherNames":70},"5% NF_TiO2","Bioactive nanoparticles",[9,16,29,34],{"type":66,"name":76,"description":77,"armGroupLabels":78,"otherNames":70},"BLEACHING GEL B","Hyaluronic Acid hydrogel + 6% Hydrogen Peroxide",[29,34,38,42],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":70},"RADIATION","VISIBLE LIGHT IRRADIATION","Low intensity visible light irradiation (405 nm)",[52,61,16,25,34,42],{"type":66,"name":85,"description":86,"armGroupLabels":87,"otherNames":70},"Whiteness HP 35%","Commercially available bleaching gel",[52,46],{"type":66,"name":89,"description":86,"armGroupLabels":90,"otherNames":70},"Whiteness HP Automixx 6%",[56,61],[92],{"name":93,"affiliation":94,"role":95},"Fernando L Esteban Florez, D.D.S., M.S., Ph.D.","The University of Oklahoma Health Sciences Center College of Dentistry","PRINCIPAL_INVESTIGATOR",[97],{"name":93,"role":98,"phone":99,"phoneExt":100,"email":101},"CONTACT","(405)271-6545","48646","fernando-esteban-florez@ouhsc.edu",[103],{"facility":94,"status":70,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Oklahoma City","Oklahoma","73117","United States","US",{"type":110,"coordinates":111},"Point",[112,113],-97.51643,35.46756,{"lat":113,"lon":112},[116],{"name":117,"role":98,"phone":118,"phoneExt":100,"email":119},"Fernando L Esteban Florez, DDS, MS, PhD","405-271-6545","festeban@ouhsc.edu",{"type":121,"investigatorFullName":70,"investigatorTitle":70,"investigatorAffiliation":70,"oldNameTitle":70,"oldOrganization":70},"SPONSOR","100577770","efficacy-and-safety-assessment-of-experimental-bleaching-agents-100577770",false,"NCT06802614","Efficacy and Safety Assessment of Experimental Bleaching Agents","A Randomized Controlled Clinical Trial Comparing the Efficacy of Two Experimental Bleaching Gels With and Without Nanoparticles and Light Irradiation Versus Whiteness HP 35% and Whiteness HP AutoMixx 6% in Patients With A2-C4 Tooth Discolorations","Inclusion Criteria:\n\n* Age: 18-65 years old.\n* Healthy periodontal tissues.\n* Willingness to participate and follow the post-treatment protocols.\n* Ability to provide informed consent.\n* Teeth having baseline colors ranging from shade A2 to C4\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Teeth with restorations.\n* History of dentin hypersensitivity.\n* Active caries, periodontal disease or endodontically treated teeth.\n* Use of substances that could affect tooth color during the trial, such as smoking and vaping.",true,"ALL","18 Years","65 Years",{"count":134,"type":135},240,"ESTIMATED","INTERVENTIONAL",[138],"NA","Tooth bleaching is widely used to treat the colors of teeth. This study compares the efficiency of two experimental bleaching gels, with and without nanoparticles, and with and without light activation versus two commercial bleaching products of low and high concentrations. The objective is to evaluate tooth color change, sensitivity, and patient satisfaction in patients with moderate yellowing of their teeth. Methods: This is a randomized controlled trial that will include 120 participants aged 18-65 years. Participants will be randomly assigned to one of 12 treatment groups: Gel A (with or without nanoparticles, with or without light), Gel B (with or without nanoparticles, with or without light), Whiteness HP 35% (with or without light) and Whiteness Automixx 6% (with or without light). The primary outcome is tooth color change, measured using a commercially-available equipment. Secondary outcomes will include tooth sensitivity and patient satisfaction. Randomization will be computer-generated. Results: The study is expected to show differences in color change between the experimental and commercial gels. Tooth sensitivity and patient satisfaction will be evaluated to determine the overall effectiveness and safety of the treatments. Conclusions: This trial will provide information into the whitening efficacy of two experimental gels compared to two widely used commercial products.",[141,142,143],"Tooth Discoloration","Dentin Sensitivity","Patient Satisfaction",[145,146,147,148],"Tooth Whitenining","Dental Bleaching","Hydrogen Peroxide","Titanium Dioxide Nanoparticles","NOT_YET_RECRUITING","2025-01-24",{"date":152,"type":153},"2025-01-31","ACTUAL",{"date":155,"type":135},"2025-03-01",{"date":157,"type":135},"2025-09-30",{"name":5,"class":6},1]