title: A randomized clinical study to assess ingestion of dentifrice by children.
abstract: This study investigated whether there was a difference in amounts of dentifrice ingested by children based on age using pea-sized instructions. The study had a randomized, single-blinded, 3-period, crossover design modelled after Barnhart et al. (1974) with one regular-flavored and two specially-flavored dentifrices used ad libitum. Subjects were enrolled in three groups: 2-4, 5-7, and 8-12 years. They were instructed to brush at home as they would normally with each dentifrice for 3 weeks (9 weeks total). On weekly study-site visits, subjects brushed with the assigned dentifrice containing a lithium marker to measure the amount of dentifrice ingested and used. Averaging across dentifrices, amounts ingested were: 0.205 g (2-4 yr), 0.125 g (5-7 yr) and 0.135 g (8-12 yr), demonstrating 2-4 year-olds ingested significantly more than older children (p ≤ 0.002). Averaging across dentifrices, amounts used were: 0.524 g (2-4 yr), 0.741 g (5-7 yr) and 0.978 g (8-12 yr) suggesting an age-related effect (p < 0.01). Findings also showed that ingestion amount for specially-flavored dentifrices may increase relative to regular-flavored dentifrice for children 2-7 years-old. This research demonstrated that dentifrice ingestion amount decreased significantly with age while usage amount increased with age. Importantly, ingestion and usage levels in younger children reflect "pea-sized" direction and were numerically lower than historical levels reported prior to this direction.
authors.affiliation: Global Product Stewardship, Procter & Gamble, 8700 Mason Montgomery Rd. Mason, OH, USA. Electronic address: strittholt.ca@pg.com.
authors.forename: C A
authors.initials: CA
authors.lastname: Strittholt
authors.affiliation: Global Product Stewardship, Procter & Gamble, 8700 Mason Montgomery Rd. Mason, OH, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: McMillan
authors.affiliation: Global Clinical Trials, Procter & Gamble, 8700 Mason Montgomery Rd. Mason, OH, USA.
authors.forename: T
authors.initials: T
authors.lastname: He
authors.affiliation: Quantitative Sciences, Biostatistics, Procter & Gamble, 8700 Mason Montgomery Rd. Mason, OH, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Baker
authors.affiliation: Quantitative Sciences, Biostatistics, Procter & Gamble, 8700 Mason Montgomery Rd. Mason, OH, USA.
authors.forename: M L
authors.initials: ML
authors.lastname: Barker
mesh_terms: D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003802:Dentifrices / Q000032:analysis; D004435:Eating; D004781:Environmental Exposure / Q000032:analysis; D005260:Female; D005421:Flavoring Agents; D006801:Humans; D018021:Lithium Chloride / Q000032:analysis; D008297:Male; D016037:Single-Blind Method
chemical_list: D003802:Dentifrices; D005421:Flavoring Agents; D018021:Lithium Chloride
keywords: Chloride-supplemented marker dentifrice; Dentifrice usage and ingestion in children; Flavored dentifrices; Fluoride dentifrices; Lithium