BriteSmile Clinical Facts

Efficacy – What Clinical Proof Does BriteSmile have to support its Whitening results?

1.University of Medicine And Dentistry of New Jersey
Clinical trial with observations at procedure, 3 month recall, and 6 month recall.
Studies done according to ADA guidelines and Protocol approved by ADA
Evaluate shade change and regression via both VitaPan Shade Guide and through Chroma-Meter Machine readings.
Average VitaPan Shade Change
Treatment 3 mo Recall 6 mo Recall
BriteSmile +8.2 +7.7 (-0.5 avg. shade +7.2 (-1.0 avg. shade
regression) regression)
Gel +5.4 +3.8 (-1.6 avg. shade +3.1 (-2.3 avg.shade
regression) regression)

1.The Forsyth Institute Ń Boston Oral Health Resource Center
Clinical trial with observations at procedure, 3 month recall, and 6 month recall.
Studies done according to ADA guidelines and Protocol approved by ADA
Evaluate shade change and regression via both VitaPan Shade Guide and through Chroma-Meter Machine readings.
Average VitaPan Shade Change*
Treatment 3 mo Recall 6 mo Recall
BriteSmile +8.3 +7.7 (-0.6 avg. shade +7.2 (-0.9 avg. shade
regression) regression)
*Preliminary data; final report in progress
1.Walnut Creek 1,000 Patient Post-Marketing Study
First 1000 Non-Tetracycline cases performed at Walnut Creek whitening center
Average Patient Pre-Procedure VitaPan Shade reading was D3
54% of all cases reached the Top of VitaPan Shade scale
74% of all cases reached A1 or better
Treatment Results
Average Patient Result +7.8 shades
Average Patient Result +8.8 shades
(Among those starting at A3 or darker)

BriteSmile Clinical Facts

Safety Ń What studies have been done to validate the safety profile of BriteSmileŐs procedure?

1.ADA Clinical Safety
2 parallel, independent clinical trials
Forsythe Institute and University of Medicine and Dentistry of New Jersey
Observations at time of treatment, 3 month recall and 6 month recall
Oral examinations revealed NO significant changes in hard or soft tissues (at treatment, 3 month, and 6 month recall)
Less than 10 % of patients reported hypersensitivity, which was completely resolved within 24 hours.

1.Safety Studies (in support of ADA Application)

Scanning Electron Microscopy
- Evaluate loss of tooth mineral
- Evaluate damage to restorative materials
- Evaluate reduction in micro hardness
“ BriteSmile whitening treatments cause no significant surface morphological or micro structural changes in tooth enamel, type IV gold alloy, composite material, amalgam, porcelain, conventional glass inomer and resin inomer.“
[Presented at the IADR 78th General Session, Washington, D.C. April 2000. Vaidyanathan et al, J. Dent. Res. 2000 79:1129]

Micro hardness of Enamel and Composite
„The result of this study showed insignificant differences between control and treated, suggesting that the BriteSmile system will not soften enamel or soften resin material.“

Enamel KHN Composite KHN
*Knoop Hardness Number
Condrol (no treatment) 337.7 41.55
BriteSmile 338.3 40.26
[Published at the IADR 78th General Session, Washington, D.C. April 2000. Nathoo et al, J. Den. Res. 2000 79:966]