Summary of the of Results for 1000 Whitening Cases at the Walnut Creek Center

Salim Nathoo, DDS, Ph.D., Antonio Margiotta, DDS and E. Joyce Dalao, DDS

Shade change analysis of the first 1000 non-tetracycline cases performed at the Walnut Creek whitening center showed an average improvement of 7.8 shades. The results showed that the darker the teeth the greater the whitening effect. An average shade improvement of 8.8 tabs was observed for cases who were darker than the average tooth color (A3 and darker). This group of patients required a change of at least eight shades to reach their optimal natural tooth whiteness i.e., the top of the whitening scale. The average pre-treatment shade of the first 1000 cases was D3. 54% of all cases reached the top of the scale as measured immediately post-treatment, 74% of patients achieved results of A1 or better (one shade from the top). 85% of patients achieved B2 or better (two shades from the top of the scale). 22% of all patients achieved 9 shades or more. 53% of patients achieved 7.5 shades or more.

Introduction

BriteSmile, Inc. develops state of the art technology to whiten teeth safely and effectively. The technology is used in company owned BriteSmile Teeth Whitening centers and also Associated Centers, which are incorporated within existing dental offices and operated by partner dentists. The purpose of this summary is to describe the results of the first 1000 cases performed at the BriteSmile Walnut Creek Whitening Center.

The BriteSmile Tooth Whitening Process

The BriteSmile 2000 teeth whitening system (patent pending) consists of a gas plasma short arc lamp filtered so as to emit in the blue-green region of the spectrum (approximately 400-500 nanometers) and a proprietary delivery system with a patent pending delivery device, which illuminates all smile teeth at once.

The BriteSmile plasma light is used in combination with a patent pending peroxide gel, which has been optimized to obtain a maximal whitening effect and to ensure patient safety. The proprietary chemistry consists of a 15% hydrogen peroxide gel buffered at an approximately neutral pH to prevent damage to teeth. The gel also contains other ingredients such as glycerin and purified water to prevent tooth dehydration and to further insure safety. The gel contains a proprietary photo-initiator, which assists in chromophore destruction at the tooth surface.

Teeth whitening was performed using the standard BriteSmile procedure which is briefly described below:

The suitability of the patient to undergo teeth whitening is determined using a standard dental medical history followed by a clinical examination of the patients mouth and oral tissues. Not all patients are considered to be suitable cases to under go teeth whitening. The most common dental reasons for rejection include:

1. Carious lesions
2. Broken or lost restorations
3. Crowns or laminates on anterior teeth
4. Periodontal disease
5. Extensive calculus

The tooth whitening procedure takes approximately 90 minutes and normally consists of the following steps:

• measure pre-treatment tooth color using a VITAPANTM System shade guide.
• the patient brushes their teeth with a special pre-whitening toothpaste to remove loose debris and stain (note: some of the acquired pellicle is removed on brushing)
• a cheek retractor is placed to expose all smile line upper and lower teeth.
• the patient bites down on a special fiber-optic positioning device.
• a standard light cured isolation material is placed on gingival or gum tissues.
• the peroxide gel is placed onto the tooth surfaces.
• the teeth are illuminated with the light for twenty minutes.
• the above two steps are repeated for a total exposure time of one hour.
• check retractors etc. are removed
• patient brushes and rinses
• post-treatment shade is measured.

All patients were treated at consistent illumination levels. The light energy was controlled using a specially designed "fiber optic positioner" which maintains a constant distance between the patient's teeth and the light source.

Tooth shade was measured by the same dental professionals in order to avoid inter-investigator variability. Attempts were made to keep the ambient light conditions the same. The VITAPANTM shade guide was ordered in terms of brightness as recommended by the manufacture, and the shade improvement was calculated by counting the tabs.

The data was collected by a chart review by an individual not involved in the clinical procedures of the first 1000 cases. For the purposes of this study all cases of intrinsic tooth staining were included with the exception of tetracycline stain.

Resultaten

De verdeling van de kleur van de tanden voor de behandeling voor deze 1000 patiënten is grafisch weer gegeven in chart 1:

De verdeling van de tandkleur na behandeling bij deze 1000 patiënten is grafisch weer gegeven in chart 2:

• de gemiddelde kleur voor behandeling was D3, de gemiddelde kleurverbetering na behandeling was 8 kleurstappen.
  
  
• de gemiddelde kleur na behandeling was A1.
  
  
• hoe donkerder de kleur voor behandeling, hoe groter de verbetering was. Bij patiënten met een donkerdere tand kleur dan het gemiddelde (A3) de kleur voor de behandeling was B3 en de kleur na behandeling A1/B2 met een gemiddelde verbetering van 8,8 kleurstappen.
  
  
• overall resultaten:

• 23% van de patiënten bereikte het resultaar van B1+
• 54% van de patiënten bereikte het resultaar van B1 of beter
• 74% van de patiënten bereikte het resultaar van A1 of beter
• 85% van de patiënten bereikte het resultaar van B2 of beter

De verdeling van de kleurveranderingen in de hele groep worden weergegeven in Cart 3: 

• The average shade change for all patients was 7.8 shades
  
  
• The average shade change for patients A3 and darker was 8.8 shades
  
  
• 22% of cases showed 9.5 shades or more

• The average pre-treatment shade for A3 and darker was B3

The frequency of post treatment shades for cases A3 and darker (no tetracycline cases) are shown in chart 5 and summarized below:

• The average post-treatment shade was A1/B2

The frequency of shade changes in individuals with a shade of A3 and darker are as follows and shown in chart 6:

• The average shade change was 8.8 shades

Predictability

While patients differ greatly in tooth color, enamel thickness, and degree of staining, the results of the first 1000 cases demonstrate that it is possible to predict in an approximate sense what the outcomes will be in a single whitening session from any given starting shade.

Chart 7 shows the average and plus/minus one sigma endpoints resulting from starting shades B2 and darker. It is therefore possible to tell a patient at an A4 starting shade, for example, that two thirds of all previous patients have achieved C1 or better (nine shades) with the average result being D2 (eleven shades) and the best being A1 (thirteen shades).

Safety

Patients generally tolerated the procedure well. Approximately 10% of patients reported discomfort of some type, including mild sudden sharp pains or a dull to moderate ache. In comparison, published literature indicates tooth sensitivity of over 50% with common dentist dispensed take home systems. A very small percentage of patients required an analgesic stronger than common everyday pain medications such as aspirin.

Conclusions

The results demonstrate that the BriteSmile system can significantly whiten teeth to most patients satisfaction after one hour of treatment and confirms the results of our earlier clinical study.

About BriteSmile

BriteSmile, Inc. has developed and manufactures the most advanced teeth-whitening technology in the United States, as well as manages state-of-the-art BriteSmile Professional Teeth Whitening Centers. BriteSmile Centers are currently operating in Beverly Hills, Irvine, Pasadena, Walnut Creek, Palo Alto and La Jolla, CA, Honolulu, HI and Atlanta, GA with more than 30 BriteSmile Teeth Whitening Systems located within existing dentist offices in cities including: Tucson, AZ; San Francisco, CA; Denver, CO; Louisville, KY; Canton, MA; Raleigh, NC; Huntington, NY; Toronto, ON; and Houston, TX. For more information about BriteSmile's procedure, call 1-800-BRITESMILE or visit the Company's Website at www.britesmile.com.

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This release, other than historical information, consists of forward-looking statements that involve risks and uncertainties such as the development and introduction of new products and the acceptance of those new products in the marketplace. Readers are referred to the documents filed by BriteSmile with the Securities and Exchange Commission, specifically the Company's current and past reports on forms 10-QSB and 10-KSB, that identify important risk factors which could cause actual results to differ materially from those contained in the forward-looking statements. BriteSmile, its subsidiaries and affiliates disclaim any intent or obligation to update these forward-looking statements. 

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