A study to assess the safety and tolerability of three toothbrushes.
This study evaluated the oral soft tissue safety and tolerability of an experimental powered toothbrush (Crest SpinBrush Pro) compared to two leading manual toothbrushes: an advanced-design manual toothbrush (Oral-B CrossAction) and a flat-trimmed toothbrush (Oral-B 40 Indicator). Manual brushes are generally viewed as safe for use, and as such are appropriate controls. A total of 140 subjects was enrolled in this single-center, randomized, examiner-blind parallel study over a four-week test period. Subjects were instructed to brush in their normal manner, twice per day for 60 seconds per use. An oral soft tissue interview and examination were conducted by a trained dentist examiner at baseline, as well as three days and four weeks after baseline to assess clinical signs and symptoms of oral irritation associated with use of the toothbrushes. Overall, there were 19 adverse events reported for 18 subjects (13% of the population). The adverse events were distributed across test groups with five subjects in the experimental powered brush group, eight in the advanced design manual toothbrush group and five in the flat-trimmed toothbrush group experiencing at least one adverse event. The most frequently reported adverse event was localized irritation/inflammation of the gingiva. All adverse events were mild in severity except for one report of severe hyperesthesia (tooth sensitivity) in the advanced-design manual toothbrush group. There were no statistically significant differences between the groups for the proportion of subjects reporting adverse events at either three days or four weeks of product use. The results of this study indicate that daily use with the Crest SpinBrush Pro powered toothbrush is at least as safe as two leading manual toothbrushes.
Papas
Athena S
AS
Tufts University School of Dental Medicine, Boston, MA, USA.
Martuscelli
Gianluca
G
Singh
Mabi L
ML
Stone
Constance
C
Bartizek
Robert D
RD
Topmiller
Krista J
KJ
Biesbrock
Aaron R
AR
Walters
Patricia A
PA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D003773:Dental Plaque / Q000628:therapy*; D003774:Dental Plaque Index; D003807:Dentin Sensitivity / Q000209:etiology; D004560:Electricity; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005891:Gingivitis / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D017060:Patient Satisfaction; D016037:Single-Blind Method; D014099:Toothbrushing / Q000009:adverse effects / Q000295:instrumentation*