title: Evaluation of the Oral Tolerance of Three Fluoride Toothpaste Formulations in a Dry Mouth Population: Results from Two Randomized Studies.
abstract: OBJECTIVE
  To evaluate the oral tolerance of three experimental toothpaste formulations containing sodium fluoride (NaF), compared with two marketed sodium monofluorophosphate (SMFP)-containing biotène® toothpastes, in a dry mouth population after 14 days (primary objective) and 7 days (secondary objective) of use.
  
  
  METHODS
  Toothpastes were tested in two separate dual-site, examiner-blind, randomized, parallel group studies in subjects (35-84 years) with self-reported dry mouth. Oral soft tissue (OST) and oral hard tissue (OHT) examinations were performed at screening, followed by a 7- to 28-day wash-in period using a control toothpaste. Subjects were randomized to receive a NaF-containing toothpaste (Study 1: commercially available toothpaste Pronamel® for Children, n = 82; Study 2: experimental plaque biofilm-loosening formula [PBF] toothpaste, n = 79; or experimental Gentle Mint toothpaste, n = 78) or a reference toothpaste (Study 1: biotène® Fresh Mint Original toothpaste [previously marketed formulation], n = 82; Study 2: biotène® Gentle Mint Gel toothpaste [previously marketed formulation], n = 77) during the 14-day treatment phase. Subjects brushed their teeth twice daily for one timed minute with a ribbon of toothpaste to cover the head of the toothbrush provided. Subjects received further OST and OHT examinations at Day 1 and Day 15, and an additional OST examination at Day 8. Adverse events (AEs) and serious AEs (SAEs) were reported throughout the study.
  
  
  RESULTS
  Study 1: At Day 15, 42 oral treatment-emergent AEs (TEAEs) were reported in 33 subjects, of which seven in five subjects (commercially available toothpaste Pronamel for Children: n = 2; control: n = 3) were considered to be treatment-related. One SAE (dyspnea) was reported in a participant who was randomized but withdrew from the study before receiving the allocated toothpaste. Study 2: At Day 15, 41 oral TEAEs were reported in 38 subjects, of which two in two subjects (experimental Gentle Mint toothpaste: n = 1; control: n = 1) were considered treatment-related, according to the investigator. No SAEs were reported.
  
  
  CONCLUSIONS
  In both studies, the experimental and reference toothpastes were well tolerated after 7 and 14 days of use. The experimental NaF-containing toothpastes offer potential alternatives to individuals with dry mouth.
authors.affiliation: GSK Consumer Healthcare, Weybridge, UK.
authors.forename: Anto
authors.initials: A
authors.lastname: Jose
authors.affiliation: GSK Consumer Healthcare, Weybridge, UK.
authors.forename: John
authors.initials: J
authors.lastname: Ward
authors.affiliation: Shneyer Statistics LLC, Parsippany, NJ, USA.
authors.forename: Lucy
authors.initials: L
authors.lastname: Shneyer
authors.affiliation: Hill Top Research, St. Petersburg, FL, USA.
authors.forename: Jacob
authors.initials: J
authors.lastname: Skinner
authors.affiliation: Hill Top Research, Winnipeg, Canada.
authors.forename: Nathan
authors.initials: N
authors.lastname: Jeal
authors.affiliation: TKL Research Inc., Ramsey, NJ, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Cronin
authors.affiliation: GSK Consumer Healthcare, Weybridge, UK.
authors.forename: Mary Lynn
authors.initials: ML
authors.lastname: Bosma
mesh_terms: D018441:Biofilms; D003773:Dental Plaque; D004311:Double-Blind Method; D005459:Fluorides; D006801:Humans; D009055:Mouth; D012969:Sodium Fluoride; D014100:Toothpastes; D014987:Xerostomia
chemical_list: D014100:Toothpastes; D012969:Sodium Fluoride; D005459:Fluorides
keywords: Pronamel® for Children; biotène®; caries; dentifrice; dry mouth; plaque biofilm; sodium fluoride; sodium monofluorophosphate; tolerance; toothpaste