Placebo-controlled clinical trial of a 6.0% H2O2 tooth whitener
At-home
tooth bleaching, which was formally introduced in 1989 by Haywood and Heymann,
traditionally involves fabrication and use of a custom-fitted soft plastic tray
for delivery of a carbamide peroxide or hydrogen peroxide gel.
Numerous laboratory and clinical studies indicate that at-home whitening
is a safe and effective procedure. Recently,
a new delivery system was developed; it contains a measured dose of 6.0%
hydrogen peroxide on a polyethylene strip.
Objectives: The purpose of this study was to compare the safety
and efficacy of the new system (Crest Whitestrips, CWS) versus a placebo
control. Methods: Forty adult patients with teeth darker than
A3 on a value-oriented Vita shade guide were enrolled in the study, and were
randomly assigned to experimental and control groups.
All subjects applied the assigned agent to the maxillary anterior teeth
for 30 minutes twice a day over a six-week period (or until the tooth shade was
B1, the lightest Vita shade). Efficacy
was measured by digital imaging at 2, 4, and 6 weeks. Safety was evaluated using an oral soft tissue examination at
the same intervals. Data were
subjected to analysis of covariance. Results:
Use of CWS resulted in a mean Db* (decrease in yellow) of 3.25 units, compared
with a change of 0.38 units for the placebo.
The corresponding values for DL* (increased lightness) were 2.73 and 0.21
units, respectively. Differences
were statistically significant (p<0.0001).
The most common adverse events were tooth hypersensitivity and gingival
irritation. Although both occurred
mainly in the experimental group, the events were generally mild and transient.
Conclusion:The results of this study indicate that Crest
Whitestrips provide statistically significant tooth whitening compared with a
placebo as measured by digital imaging.
Supported by Procter & Gamble.
Division: IADR/AADR/CADR General Session
Meeting:2002 IADR/AADR/CADR General Session (San Diego, California) Location: San Diego, California
Year: 2002 Final Presentation ID:1955 Abstract Category|Abstract Category(s):Dental Materials: IV - Clinical Trials
Authors
Swift, Edward
( University of North Carolina, Chapel Hill, NC, USA
)
Heymann, Harald
( , , ,
)
Wilder, Aldridge
( , , ,
)
St-georges, Annie
( , , ,
)
Nunes, Mauro
( , , ,
)
SESSION INFORMATION
Poster Session
Clinical Evaluations of Tooth Bleaching and Sensitivity
03/08/2002