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Forsyth letter

The Forsyth Institute in Boston has been conducting clinical research on the BriteSmile system. The purpose of the research, done in accordance with ADA guidelines, is to document the safety and efficacy of the BriteSmile system pursuant to applying for the ADA Acceptance Seal.

Dr. Max Goodson of the Forsyth Institute has forwarded the results of the first phase of the study to us, and the results are impressive. A snapshot of the conclusions:

„As expected, application of peroxide by itselfÉhad a significant bleaching effect.“ „The combination of the two [light plus peroxide], however, resulted in [a] significant increment in tooth whitening not achieved by either peroxide or light alone“É “ As designed, this study clearly demonstrates the additive effects of light and peroxide in tooth bleaching“

A full copy of the report will be made available as soon as it is submitted for formal publication. In the mean time, we would like to share these preliminary conclusions with our many dental partners.

First, a note about the research objectives and methodology supporting BriteSmileŐs application for the ADA Seal:

Objective

The overall objective is to independently document that the BriteSmile system is safe and effective. To meet the ADA safety standards, the results of the studies have to demonstrate that the process does not adversely affect soft and hard tissues of the mouth. To meet the efficacy standards, the studyŐs results have to show that the elements of the system demonstrably whiten teeth. Included in this requirement is the necessity that the light have an additive role in the whitening of teeth. This latter is a requirement that BriteSmile wholeheartedly endorses, and has been core to BriteSmileŐs entire professional offering.

Methodology

Parallel design clinical trial of 87 subjects randomly assigned to three experimental groups

  • The test group. (the full BriteSmile therapy; BriteSmile light plus the 15% hydrogen peroxide gel).
  • The peroxide control group. (BriteSmile 15% hydrogen peroxide gel alone).
  • The light control group. (BriteSmile light alone with a placebo gel)

Insofar as possible, the treatments were blinded to the examiner and the subject (i.e. a lack of light in control group 2 could not be blinded from the subject, but the fact the subject was in control group 2 was not known to the examiner).

Tooth color measurements were subjectively evaluated using a standard Vita Shade guide, and objectively evaluated using a chromameter (Minolta CR 321).

Safety was evaluated by professional oral examination and a subject questionnaire.

The results of the study at Forsyth clearly support BriteSmileŐs previous research in this field.

As measured on the somewhat subjective Vita ™ shade guide, the BriteSmile process whitened teeth to a significantly greater degree than did either the gel or light alone. The report found an average change of 8.34 shade guide increments using the revolutionary BriteSmile technology. The peroxide control group experienced a bleaching effect of 5.89 shade tabs and the light controlŐs bleaching effect was 4.93 shade tabs. Both the Forsyth and BriteSmile researchers noted an unexpected result of the light alone contributing significantly to whitening; this will be the subject of further research.

As measured objectively with the chromameter, the differences between the arms of the study were even more striking, particularly with regard to reduction of yellow (the „b“ value in chromametric measures). The BriteSmile process reduced the yellow values by a mean of 4.07, the peroxide alone reduced the yellow value by 1.65, and the light alone reduced yellow by 1.3.

A very impressive outcome of the study was the measurement of patientŐs perceptions. 96.6% of the patients who experienced the full BriteSmile treatment noted that the treatment moderately or greatly increased the whiteness of their teeth, while only 39.3% of the peroxide-only, and 53.6% of the light-only groups reported this same level of whitening.

The side effects profile was in line with previous reports. Interestingly, the differences in subject perception of tooth sensitivity were statistically the same between those who had the full treatment and those who had the peroxide gel alone. The group that experienced the light alone reported only 9% incidence of „slight sensitivity, and the balance reported no sensitivity at all.

This research could not come at a better time; we are aware that the question of both the theoretical potential for, and clinical experience of, light-activated teeth whitening is hotly debated. In the April edition of „Dentistry Today,“ Van Haywood stated, „Someone needs to conduct a clinical double-blind, evidence-based studyÉif they wish to prove that lightsÉare indeed efficacious for bleaching.“ In a recent CRA Status Report, CRA asserts that „clinical use of light & or heat during in-office does not lighten teeth beyond the use of bleach alone, once teeth have rehydrated 2-5 days following treatment“ (As a side note in this same report CRA mentions a „BriteSmile Heat Lamp“ as having been an element of the research; Rella Christensen separately reported that this heat lamp is not our current system but a heat lamp made for the discontinued laser procedure. CRA is printing a clarification in the September issue of the „Newsletter.“).

We have always believed that lumping our proprietary process in with all laser, curing light and heat-lamp based processes is inappropriate. Given the acrimoniousness of this debate, we continue to believe it necessary to conduct our research with independent agencies of impeccable research credentials. Without any doubt, Forsyth meets these standards. It is consequently with great pride that we are able to disclose to both the clinical and academic dental community the results of this remarkable and groundbreaking study.

There are a great many more exciting findings and observations contained in the report, some of which are included in the attached excerpts from the study. The complete report will be made available to anyone requesting it as soon as it is submitted for publication.
We hope that you find these results as compelling and exciting as we do, and that they are reflected in your clinical practice. Thank you again for your support.

Sincerely,

John Reed & Andrew Hofmeister
Chief Executive Officer President & Chief Technology Officer