Randomized clinical trial comparing overnight use of two self-directed peroxide tooth whiteners.
OBJECTIVE
To directly compare tooth color change and spatial uniformity of two brush-applied, peroxide-based overnight tooth whiteners in a 2-week randomized clinical trial.


METHODS
57 adult volunteers were randomly assigned to Crest Night Effects, a 19% sodium percarbonate system packaged in unit dose sachets that when applied, dries to form an adherent film, or Colgate Simply White Night, a paint-on liquid in an applicator bottle at a concentration of 8.7% hydrogen peroxide. Both groups applied their assigned gel on the facial surfaces of the six maxillary anterior teeth for 14 nights. Efficacy was measured objectively as change in L*a*b* tooth color from standard digital images of maxillary teeth, while safety was evaluated by clinical examination and interview.


RESULTS
After 14 nights treatment, adjusted mean (SE) change in yellowness (delta b*) was -0.95 (0.092) for the 19% sodium percarbonate film and -0.17 (0.096) for the 8.7% hydrogen peroxide gel, with these groups differing statistically (P < 0.0001). Other individual and composite color parameters also demonstrated significantly greater whitening for the 19% sodium percarbonate film compared to the 8.7% hydrogen peroxide gel after 14 nights use. Only the 19% sodium percarbonate film exhibited significant (P< 0.0001) proximal color improvement (delta b*) after 2 weeks, approximately 98% of that seen on the body of the tooth, providing evidence of proximal bleaching and uniform spatial whitening following use of this barrier-free system. Both products were well-tolerated, with no subjects discontinuing treatment early due to a causal adverse event.
Gerlach
Robert W
RW
HillTop Research, Inc., Miamiville, Ohio, USA. gerlach.rw@pg.com
Barker
Matthew L
ML
D000287:Administration, Topical; D000328:Adult; D002254:Carbonates / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006861:Hydrogen Peroxide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010545:Peroxides / Q000008:administration & dosage*; D020034:Silicone Gels / Q000008:administration & dosage; D014073:Tooth Bleaching / Q000379:methods*; D014075:Tooth Discoloration / Q000188:drug therapy; D016896:Treatment Outcome
D002254:Carbonates; C485070:Colgate Simply White Night; C479358:Crest Night Effects; D010545:Peroxides; D020034:Silicone Gels; D006861:Hydrogen Peroxide; C034738:sodium percarbonate