ABSTRACT

Clinical Evaluations of a Novel Bleaching System

Yu X, and Li Y, S. Lee, S. Cartwright, and R. Saxe Den-Mat, Loma Linda University, USA

Objective:

The aim of these studies was to evaluate efficacy and safety of a dual syringe hydrogen peroxide bleaching material and compare its efficacy to another product.

Method:

Two separate clinical trials were conducted at a university dental center. Combined sample size was 104. Study participants were supplied with the Rembrandt product (high strength whitening system utilizing hydrogen peroxide and catalytic activator) or Crest Whitestrips. Products were applied twice daily, Rembrandt with 15 and 30 minute application times, Whitestrips with 30 minutes. Results were evaluated after varying numbers of days of use. Whitening was measured on maxillary incisors using the Bioform Color Ordered Shade Guide.

Results:

Outcomes from both trials were consistent, showing significant whitening from before to after treatment (p<0.001). Longer bleaching times resulted in greater shade change. The Rembrandt product gave significantly greater whitening than Whitestrips in both studies (p<0.01), even when applied only half as long (15 minutes, Study 2).

Study	N	Product	Day	Applic-ations	Application Time (Min)	Bleaching Time (Hr)	Shade Change
1	26	Rembrandt	14	28	30	14.0	9.35±3.02
1	28	Whitestrips	14	28	30	14.0	6.98±2.58
2	26	Rembrandt	3	6	15	1.5	5.27±3.14
2	26	Rembrandt	7	14	15	3.5	7.01±3.10
2	26	Rembrandt	14	28	15	7.0	8.86±3.17
2	24	Whitestrips	3	6	30	3.0	3.11±2.41
2	24	Whitestrips	7	14	30	7.0	4.35±2.56
2	24	Whitestrips	14	28	30	14.0	5.35±2.74

The whitening treatments were well tolerated without any significant adverse visual change on soft or hard oral tissue.

Conclusion:

Outcomes in two clinical trials demonstrated a highly significant whitening benefit for this Rembrandt bleaching material, and superior whitening versus a strip product.

AbstractNovelBleachingProductV8

9/30/03