{"id":"amine-fluoride-toothpaste","safety":{"commonSideEffects":[{"rate":null,"effect":"Dental fluorosis (with excessive ingestion)"},{"rate":null,"effect":"Mild gingival irritation"},{"rate":null,"effect":"Unpleasant taste"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amine fluoride is an organic fluoride compound that penetrates tooth enamel more effectively than inorganic fluorides, promoting remineralization of early carious lesions and creating a protective fluoride layer. The amine component enhances substantivity (prolonged retention on tooth surfaces), extending the anti-cariogenic effect beyond the brushing period.","oneSentence":"Amine fluoride toothpaste delivers fluoride ions to tooth enamel to strengthen it and prevent dental caries through remineralization.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:01:15.464Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of dental caries (cavities)"},{"name":"Remineralization of early enamel lesions"},{"name":"Fluoride supplementation for caries-prone patients"}]},"trialDetails":[{"nctId":"NCT07414173","phase":"PHASE4","title":"6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health","status":"RECRUITING","sponsor":"Colgate Palmolive","startDate":"2026-01-28","conditions":"Gingivitis, Dental Plaque Accumulation","enrollment":90},{"nctId":"NCT06240481","phase":"PHASE3","title":"Clinical Research Study to Assess the Efficacy of Two Brushing Regimens","status":"COMPLETED","sponsor":"Colgate Palmolive","startDate":"2024-09-23","conditions":"Dental Plaque, Gingivitis","enrollment":90},{"nctId":"NCT04933331","phase":"","title":"Early Caries Lesion Management Observational Study","status":"UNKNOWN","sponsor":"CareQuest Institute for Oral Health","startDate":"2020-12-07","conditions":"Initial Caries, Arrested Dental Caries, Cavitated Caries","enrollment":744},{"nctId":"NCT03996044","phase":"PHASE1","title":"Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction","status":"COMPLETED","sponsor":"University of Nove de Julho","startDate":"2021-01-20","conditions":"Halitosis","enrollment":52},{"nctId":"NCT05628571","phase":"PHASE3","title":"Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate","status":"UNKNOWN","sponsor":"Hospital Israelita Albert Einstein","startDate":"2023-02-01","conditions":"Oral Bacterial Infection","enrollment":130},{"nctId":"NCT05596149","phase":"NA","title":"Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa","status":"UNKNOWN","sponsor":"University of Zagreb","startDate":"2022-11-01","conditions":"DNA Damage","enrollment":80},{"nctId":"NCT02740803","phase":"NA","title":"Total Salivary Fluoride Concentration of Healthy Adult Subjects Following Toothbrushing With Different Formulations of Fluoridated Toothpastes With and Without Post-brushing Water Rinsing.","status":"COMPLETED","sponsor":"University of Leeds","startDate":"2016-04","conditions":"Caries","enrollment":120},{"nctId":"NCT02552589","phase":"NA","title":"Effect of Toothpaste on the Reduction of Plaque and Inflammation","status":"COMPLETED","sponsor":"Technische Universität Dresden","startDate":"2015-09","conditions":"Gingivitis, Dental Plaque","enrollment":241},{"nctId":"NCT01005966","phase":"PHASE3","title":"In Situ Caries Model of Fluoride Toothpastes","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-11","conditions":"Caries","enrollment":65}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"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":"Amine Fluoride Toothpaste","genericName":"Amine Fluoride Toothpaste","companyName":"GlaxoSmithKline","companyId":"glaxosmithkline","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Amine fluoride toothpaste delivers fluoride ions to tooth enamel to strengthen it and prevent dental caries through remineralization. Used for Prevention of dental caries (cavities), Remineralization of early enamel lesions, Fluoride supplementation for caries-prone patients.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}