Safety of three toothbrushes.
OBJECTIVE
To assess the oral soft tissue safety and tolerability of two electric toothbrushes, the Crest Spin Brush and Colgate ActiBrush, and one manual toothbrush, the Oral B 40.


METHODS
A total of 104 subjects were enrolled in this single center, randomized, examiner-blind parallel study over a 4-wk test period. Subjects were randomized to treatment and were instructed to brush in their normal manner, twice per day for 60 s. A detailed oral soft tissue examination and interview were conducted by a trained clinician at baseline, 3 days and 4 wks to assess clinical signs and symptoms associated with use of the toothbrushes.


RESULTS
Over the 4-wk period, a total of 19 subjects (18% of the study population) were observed for signs/symptoms. The adverse events were distributed across test groups with 12 subjects in the Oral B 40 group, 4 subjects in the Crest Spin Brush group, and 3 subjects in the Colgate ActiBrush group experiencing at least one adverse event. All adverse events were mild in severity indicating the general safety of all three toothbrushes. The most frequently encountered event was localized gingivitis. The Oral B 40 test group was observed with more adverse events when compared to the Crest Spin Brush and Colgate ActiBrush at 4 wks but not at 3 days. The proportion of subjects experiencing an adverse event in the Crest Spin Brush test group was similar to that of Colgate ActiBrush group. All three toothbrushes were generally well tolerated by subjects enrolled in the study with the Crest Spin Brush and Colgate ActiBrush being the best tolerated.


CONCLUSIONS
The results of this study indicated that abnormal oral soft tissue findings were distributed among the treatment groups, indicating that daily use of an electric toothbrush is at least as safe as a manual toothbrush.
He
T
T
The Procter & Gamble Company, Cincinnati, Ohio, USA. he.t@pg.com
Carpinello
L
L
Baker
R
R
Knippenberg
S
S
Das
A
A
Winston
L
L
McClanahan
S
S
D000328:Adult; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D005891:Gingivitis / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D019226:Oral Ulcer / Q000209:etiology; D016037:Single-Blind Method; D013223:Statistics as Topic; D014099:Toothbrushing / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods