{"id":"bifluorid-12","safety":{"commonSideEffects":[{"rate":null,"effect":"Tooth staining or discoloration"},{"rate":null,"effect":"Mild gingival irritation"},{"rate":null,"effect":"Temporary fluorosis (with excessive use)"}]},"_chembl":{"chemblId":"CHEMBL2109480","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bifluorid 12 contains 12% fluoride in a colophony-based varnish formulation that adheres to tooth surfaces, allowing prolonged contact and penetration of fluoride ions into enamel. The fluoride promotes remineralization of demineralized enamel and inhibits bacterial acid production, reducing caries risk. The varnish vehicle extends fluoride retention on teeth compared to rinses or gels.","oneSentence":"Bifluorid 12 is a topical fluoride varnish that delivers high-concentration fluoride to tooth surfaces to prevent dental caries and remineralize early enamel lesions.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:14.230Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dental caries prevention in children and adults"},{"name":"Remineralization of early enamel caries lesions"},{"name":"Dentine hypersensitivity management"}]},"trialDetails":[{"nctId":"NCT07455604","phase":"PHASE2","title":"Preventing Early Childhood Caries With a Silver Diamine Fluoride Gel","status":"ACTIVE_NOT_RECRUITING","sponsor":"The University of Hong Kong","startDate":"2026-01-01","conditions":"Early Childhood Caries (ECC)","enrollment":1500},{"nctId":"NCT07229105","phase":"NA","title":"Comparative Effectiveness of Remineralization Agents on Attachment-Associated Demineralization in Clear Aligner Patients","status":"COMPLETED","sponsor":"Bezmialem Vakif University","startDate":"2024-08-12","conditions":"White Spot Lesions, Demineralization, Dental Caries","enrollment":40},{"nctId":"NCT06829277","phase":"NA","title":"Evaluation of Biomimetic Mineralization Plus Soft Laser Irradiation in Dentin Hypersensitivity Management","status":"COMPLETED","sponsor":"MTI University","startDate":"2024-11-01","conditions":"Dentin Hypersensitivity","enrollment":84},{"nctId":"NCT04887389","phase":"PHASE4","title":"Cariostatic and Remineralizing Effects of Three Different Dental Varnishes","status":"COMPLETED","sponsor":"Nisreen Ibrahim khan","startDate":"2021-08-01","conditions":"Dental Caries in Children, Cariostatic Agent, Resistance, Dental Caries","enrollment":115},{"nctId":"NCT05791669","phase":"PHASE3","title":"Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution","status":"COMPLETED","sponsor":"Postgraduate Institute of Dental Sciences Rohtak","startDate":"2021-08-01","conditions":"Caries Arrested","enrollment":45},{"nctId":"NCT04930458","phase":"NA","title":"Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate","status":"UNKNOWN","sponsor":"University of Baghdad","startDate":"2021-08-10","conditions":"Dental Caries","enrollment":135},{"nctId":"NCT05084001","phase":"PHASE2, PHASE3","title":"Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth","status":"UNKNOWN","sponsor":"The University of Hong Kong","startDate":"2020-03-01","conditions":"Dental Caries in Children","enrollment":769},{"nctId":"NCT04929509","phase":"NA","title":"P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions","status":"UNKNOWN","sponsor":"Hams Hamed Abdelrahman","startDate":"2020-12-05","conditions":"White Spot Lesion","enrollment":66},{"nctId":"NCT03082196","phase":"PHASE2","title":"Efficacy Of A PVP-I Fluoride Varnish","status":"COMPLETED","sponsor":"Advantage Dental Services, LLC","startDate":"2017-03-30","conditions":"Dental Caries","enrollment":284},{"nctId":"NCT03865680","phase":"PHASE2","title":"Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth","status":"COMPLETED","sponsor":"Nourhan M.Aly","startDate":"2019-04-28","conditions":"White Spot Lesion","enrollment":180},{"nctId":"NCT04225247","phase":"PHASE3","title":"Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity","status":"COMPLETED","sponsor":"Dow University of Health Sciences","startDate":"2018-03-07","conditions":"Dentin Hypersensitivity","enrollment":105},{"nctId":"NCT03990935","phase":"NA","title":"Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2019-07","conditions":"White Spot Lesions","enrollment":60},{"nctId":"NCT03818945","phase":"PHASE4","title":"the Efficacy of Giomer Versus Sodium Fluoride in the Treatment of Hypersensitivity","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2019-03-01","conditions":"Tooth Hypersensitivity","enrollment":104},{"nctId":"NCT03571815","phase":"NA","title":"Cost Effectiveness of Sodium Fluoride Varnish in Prevention of Dental Caries in School Children","status":"COMPLETED","sponsor":"University of Peradeniya","startDate":"2015-01-02","conditions":"Dental Caries in Children","enrollment":328},{"nctId":"NCT03557996","phase":"PHASE4","title":"Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2018-12-01","conditions":"Dental Caries in Children","enrollment":42},{"nctId":"NCT03554980","phase":"PHASE4","title":"Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2018-12-01","conditions":"Dental Caries in Children","enrollment":46},{"nctId":"NCT01829334","phase":"PHASE2","title":"Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth","status":"COMPLETED","sponsor":"The University of Hong Kong","startDate":"2006-06","conditions":"Dental Caries","enrollment":329}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Bifluorid 12","genericName":"Bifluorid 12","companyName":"Dow University of Health Sciences","companyId":"dow-university-of-health-sciences","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bifluorid 12 is a topical fluoride varnish that delivers high-concentration fluoride to tooth surfaces to prevent dental caries and remineralize early enamel lesions. Used for Dental caries prevention in children and adults, Remineralization of early enamel caries lesions, Dentine hypersensitivity management.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}