Randomized clinical trial comparing overnight use of two self-directed peroxide tooth whiteners

Abstract

Purpose: 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.