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Clinical Studies

Dr. I.C. Cervini
Pilot Study "W"
Clinical Study To Establish Efficacy and Safety of "The Institute for the Advancement of Musical Science" Professor Bocelli Dissolvable Tooth Whitening Strips & System"
Sponsored By The Institute for The Advancement of Musical Science
Prepared By: Dr. I.C. Cervini
B.Sc., D.D.S., F.A.G.D., F.I.C.D., F.A.D.I., F.P.F.A...

This is to inform you that the initial study on Professor Bocelli Dissolvable Tooth Whitening Strip system is complete and a full preliminary report with photographs is attached.
Preliminary results show that this system is simple and efficient and enjoyable in the process of whitening teeth. The only mitigating factor, which could change results, is what type of "IPOD" or music resource is used to produce the energy needed in the breakdown of the Hydrogen Peroxide to release the energy for the whitening.
The purpose of the study "W" was to evaluate both the efficacy and the safety of "Professor Bocelli Dissolvable Tooth Whitening Strip system" as well as establishing both satisfaction and acceptability by and from the subjects of the study.
This preliminary study consisted of two subjects, which were screened as to ability to participate. Each was given a protocol to read which explained the pros and cons of tooth whitening and the method used in this study.
A medical history was taken and an oral exam was carried out to examine inclusion or exclusion characteristics of the subjects. Both selected participants signed an informed consent form and photographs were taken to establish a base line shade.
Product safety was evaluated by clinical examination of hard and soft tissues of the oral cavity at the beginning and at the end of the study (after Seven Days). Product efficacy was determined by direct comparison using the standard VITA Shade Guide.
INTRODUCTION:
Today bleaching or whitening of teeth is both an accepted and sought-after mode of cosmetic enhancement. It is an accepted clinical procedure in any dental office. The public on the other hand is seeking a safe and effective home bleaching system, which is cost effective as well as efficient and quick in achieving the same results. Hydrogen Peroxide has been proven over and over again to be very safe and efficient by many well-documented studies that have been accepted by the FDA and Health Canada and all officiated Dental Associations.
The Institute for the Advancement of Musical Science (IAMS) in its desire to satisfy public demands has introduced the Professor Bocelli Dissolvable Tooth Whitening Strips and at the same time makes the process an enjoyable experience which one would look forward to daily.
The strips are peeled from the backing, placed on the teeth, one strip for the top and one for the bottom, molded by finger pressure to the tooth surface and between the teeth. Then you turn your musical player up as loud as you can, put the mouth tray to your ear and if you can hear the music coming from the tray it is working correctly. Place the tray in your mouth and adjust the music from the controller on the cable for your earphones to a comfortable listening level to "Rock Your Teeth White". The procedure should be done once a day for 15-30 minutes. Once the treatment is complete wash your tray off with hot water and dry for storage. The Hydrogen Peroxide in the strips is activated by energy from the sound waves. The breakdown of the Hydrogen Peroxide is an oxidation reaction releasing energy. It is this release of energy from the breakdown of the strips, which cleans the surface of the enamel and also causes the demineralization of the walls of the enamel prisms, which allows the cleansing of the area internally. Because whitening is directly proportional to the amount of time that the bleaching agent is in contact with the tooth surface, the slow breakdown allows more time for the release of energy to be in contact with the tooth and therefore more whitening possibility.
The reaction is PH neutral so that the subject experiences no sensitivity and a surface flavoring on the strip also enhances the taste of the dissolved strip. During the (7) seven days of treatment there is to be no coffee or tea, no red wine or cigarette smoking as these would actually cause more staining since the walls of the enamel prisms are opened for approximately twenty-four hours. It takes the body that time to remineralize the enamel prism walls.
MATERIALS AND METHODS
Professor Bocelli Dissolvable Tooth Whitening Strips are supplied by [ IAMS ] and were used according to the protocol. The two subjects that were chosen for this pilot study "W" were selected at random based on the inclusion/exclusion criteria shown below.
Prior to the initiation of the study, each subject was required to sign an informed consent form shown in the protocol and asked to read the instructions with regards to use. Any questions regarding the procedure were answered at that time.
Pre-treatment photographs were taken of all accepted candidates and more Photographs were taken at Day 7 Day. The camera used was a Pentax MZ-7 camera with a 100mm lens and a ring flash. Full-face views were taken using lens setting 1/10 and f 5.6 and intra orally at 1/2 and f 22, 100 ISO Fuji film was used.
Each Subject was given a set of instructions included with the strips and were advised to return to the office for re-examination of tissues, shade change documentation and photographs after 7 days of treatment. Tooth shade was measured using the standard VITA shade color guide. Arranging the guide according to the manufacturer's instructions and counting tabs measured color change.
The arrangement of the shade guide and the tab numbering system is shown in table #1
Efficacy results can be seen in table #2.
Safety evaluations of the soft and hard tissues were recorded and can be found under Results and Recommendations.

Table 1
VITA Shade Guide Arrangement
TAB      NUMBER
b1      0
a1      1
b2      2
d2      3
a2      4
c1      5
c2      6
d3      7
a3      8
d4      9
b3      10
a3.5      11
b4      12
c3      13
a4      14
c4      15
RESULTS
TABLE 2

SUBJECT #      Shade DAY 1      Shade DAY 7      TOTAL CHANGE
IAMS W-1           A3.5                        c1                          6
IAMS W-2           A3                          d3                           1

*There is a definite difference in these two subjects. More treatments are needed to see what caused the difference in results as both subjects started with basically the same shade. A possibility could be the music player used and the intensity of the sound waves produced.
Clinical oral examinations of both subjects showed no adverse reactions such as soft tissue irritation or hard tissue sensitivity.

Subject Comments:

1.No sensitivity.
2.Easy to use.
3.Subject W-1 very happy with results.
4.Subject W-2 not thrilled with method.
5.No pain, no tissue discomforts.
6.Sometimes strips did not totally dissolve in 30 minutes.

In conclusion, there were no adverse effects, no soft tissue irritation or sensitivity. We can therefore conclude from this very early study that "Professor Bocelli Dissolvable Tooth Whitening Strip System" is a safe and fun method of whitening teeth.

Efficacy:The efficacy of this product used in this manner is acceptable but more studies are needed.

Discussion:The results of the study definitely show that this product is capable of whitening teeth with both safety and efficacy and that the only factor, which can cause a differential, is the musical sound provider.

Clinical Study Number Two
Dissolvable Tooth Whitening Strips Clinical

Dr. Gene Cervini
The dissolvable tooth whitening strips is a unique, patent pending, technology. It incorporates two distinct layers.

The Whitening Layer that is applied to the tooth surface. It contains to active tooth whitening agents: hydrogen peroxide and PVP. It is readily soluble for fast whitening action.

The Outer Layer is slow dissolving to protect the soft tissue from the effects of hydrogen peroxide. It also contains a breath freshening vanilla-mint flavor in addition to the anti-tartar agent, sodium tripolyphosphate.

After the easy application of the strips, the teeth are left feeling clean without any need to brush and no messy strips to throw away. The pH neutral strips are gentle and non-irritating. The fast acting strips should dissolve in approximately 5 minutes.

Clinical Summary

The purpose of this clinical was to evaluate the safety and efficacy of dissolvable tooth whitening strips as well as establishing satisfaction and acceptability from the patients in the study.

A two-week clinical trial was conducted to demonstrate the products whitening efficacy. The level of whitening was measured by the industry standard, the Vita Shade Guide. Photographs were taken to verify and record the shade changes.

Observations:

Strips were very easy to use- 100% of subjects.

There were not complaints of sensitivity from any patient nor was there any inflammation of the gum tissue in any form.

The average patient experienced 3.5 shades lighter after the clinical.

100% of patients experienced some shade change.

Clinical Study of the Bocelli Twist & Use Whitening Pen

Material Safety Data Sheet
MSDS No. 8075600        Date of Preparation: 18-Feb-04

Section 1 - Product Identification

Product Name: Brush-pen Whitening Gel
Company Identification: Natural White (a div. of Lornamead Brands Inc.)
175 Cooper Avenue Medical
Tonawanda, New York 14150

Section 2 - Composition / Information on Ingredients

Ingredient Name              % wt       CAS Number
Hydrogen Peroxide          <10.0       7722-84-1
Ammonium Hydroxide       <5.0       1336-21-6
(consumed in the neutralization)

Section 3 - Hazards Identification
***** Emergency Overview *****

Translucent gel

May cause eye irritation or damage
Not a fire hazard
Not an environmental hazard

Potential Health Effects

Under normal conuser use, likelihood of adverse health effects is minimal.
Product should not irritate intact gums. Avoid use if gums are already irritated, or if gingivitis (gum disease) is present
Decrease frequency of use if irritation occurs.

Primary Entry Routes: oral, eye

Acute Effects
  Inhalation: None known
  Eye: May cause irritation or burning upon contact.
  Skin Contact: May cause irritation or burning if left on undiluted.
  Ingestion: Ingestion of amounts much greater than normal use could cause GI irritation, burning or bloating.
Chronic Effects: none expected. (Use longer than 14 days should be under supervision of a dentist.)

Section 4 - First Aid Measures

Inhalation: Not applicable
Eye Contact: Rinse thoroughly with water for 15 minutes. If irritation persists, seek medical attention.
Skin Contact: Rinse thoroughly with warm water.
Ingestion: For ingestion of amounts much greater than normal use, administer water to dilute stomach contents; do not induce vomiting
After first aid, get appropriate in-plant, paramedic, or community medical support, if needed.

Section 5 - Fire-Fighting Measures

Flash Point: None
Flash Point Method: Not applicable
LEL: Not applicable
UEL: Not applicable
Flammability Classification: Non-flammable
Extinguishing Media: water unless contraindicated by other material involved in fire

Unusual Fire or Explosion Hazards: Possible reaction hazard (for bulk quantities) if product is concentrated by water evaporation.
Hazardous Combustion Products: None known
Fire-Fighting Instructions: Do not allow product to evaporate to dryness.
Fire-Fighting Equipment: normal equipment and air supplied

Section 6 - Accidental Release Measures

Scoop up solids into a waste container. Absorb liquids with appropriate inert absorbent.
Wash away small quantities of residual material with water. Product spills may present a slipping hazard.
Use caution during cleanup and flush area thoroughly with water.

Section 7 - Handling and Storage

For bulk containers and case quantities: Keep containers closed and store product at ambient temperatures away from direct sunlight. Avoid freezing or excessive heat. Avoid contacting eyes with product.

Section 8 - Exposure Controls / Personal Protection

Respiratory Protection: None required
Protective Gloves: Not generally required. Wear general-purpose gloves if handling bulk product.
Eye Protection: Not normally required. Wear safety glasses or goggles if handling bulk product.

Consumer warnings: Avoid contact with eyes.
Avoid use if gums are already irritated, or if gingivitis (gum disease) is present.
Follow package directions.

Section 9 - Physical and Chemical Properties

Physical State: Gel                                 Water Solubility: Soluble

Appearance and Odor: Faint chemical       Boiling Point: Not determined

Odor Threshold: Not known                       Freezing/Melting Point: Not determined

Vapor Pressure: Not determined                % Volatile: N/A

Vapor Density (Air=1): Not determined       Evaporation Rate: low, not determined

Specific Gravity (H2O=1, at 4 °C): 1.14-1.22
pH: 5.5-7.0

Section 10 - Stability and Reactivity

Stability: product is stable at room temperature in closed containers under normal storage and handling conditions.
Polymerization: Hazardous polymerization will not occur.
Chemical Incompatibilities: Avoid contact of bulk product with reducing agents, organic compounds, and powdered metals.
Conditions to Avoid: None, but keep in a cool place, out of the light, for maximum length of product potency.
Hazardous Decomposition Products: None known

Section 11- Toxicological Information

Eye Effects: Irritation possible                    Acute Oral Effects: Considered non-toxic

Chronic Effects: None known

Skin Effects: Not a primary irritant              Carcinogenicity: No

Mutagenicity: No

Acute Inhalation Effects: Not applicable       Teratogenicity: No

Section 12 - Disposal Considerations

See incompatibilities below. Small quantities of product are non-hazardous. Landfill this product in accordance with all applicable regulations. Dilute and drain small amounts to sewer. Of course, any disposal practice must be in compliance with local, state and federal regulations for your particular facility.

Section 13 - Transportation Information

D.O.T. Shipping Name: Not regulated
Technical Shipping Name: Tooth Whitening Gel
D.O.T. Hazard Class: None
U.N./N.A. Number: None
Hazardous Substance/RQ: None
D.O.T. Label: None
D.O.T. Placard: None

Section 14 - Regulatory Information

Consumer Use:

USA: Considered cosmetic and are not regulated by any US governmental agency

Canada: Regulated by the Food and Drugs Act and Hazardous Products Act, and as such, are exempt from WHMIS.

Section 15 - Other Information

Prepared By: J. Lokken, C. Bowers

Revision Date: 8/7/07

Disclaimer: This MSDS is offered solely for your information, consideration and investigation. This MSDS is intended to provide a brief summary of our knowledge and guidance regarding the use of this material.
Natural White Inc. provides no warranties, either expressed or implied and assumes no responsibility for the accuracy or completeness of data contained herein. Natural White urges persons receiving this information to make their own determination as to the information suitability for their particular application.

Clinical Study of the Dissolvable Tooth Whitening Strips

Material Safety Data Sheet
MSDS No. 8700940        Date of Preparation: 23-Nov-05

Section 1 - Product Identification

Product Name: Dissolvable Tooth Whitening Film
Company ID: Lornamead Brands
175 Cooper Ave Medical
Tonawanda, NY 14150

Section 2 - Composition / Information on Ingredients

Ingredient Name              % wt       CAS Number
Hydrogen Peroxide          <10.0       7722-84-1

Section 3 - Hazards Identification
***** Emergency Overview *****

Transparent, water white film, mint odor

Slight eye irritation potential
Not a fire hazard
Not an environmental hazard

Potential Health Effects

Primary Entry Routes: oral, eye

Acute Effects
  Inhalation: None known
  Eye: May cause irritation, redness, and pain.
  Skin Contact: No adverse effects expected on intact skin. Contact on open skin may cause stinging pain or irritation.
  Ingestion: Edible in normal use. Ingestion of a large number of strips at once could cause irriation.
Medical Conditions Aggravated by Long-Term Exposure: None known

Section 4 - First Aid Measures

Inhalation: Not applicable
Eye Contact: Rinse thoroughly with water. If irritation persists, seek medical attention.
Skin Contact: Rinse thoroughly with warm water.
Ingestion: Not applicable unless a large number of strips inserted at once. If irritation occurs, seek medical advice.

Section 5 - Fire-Fighting Measures

Flash Point: None
Flash Point Method: Not applicable
LEL: Not applicable
UEL: Not applicable
Flammability Classification: Non-flammable
Extinguishing Media: water, dry chemical, alcohol foam, CO2
Unusual Fire or Explosion Hazards: None known
Hazardous Combustion Products: None known

Fire-Fighting Instructions: Do not release runoff from fire control methods to sewers or waterways.
Fire-Fighting Equipment: Because fire may produce toxic thermal decomposition products, wear a self-contained breathing apparatus (SCBA) with a full facepiece operated in pressure-demand or positive-pressure mode.

Section 6 - Accidental Release Measures

Scoop up solids into a waste container. Absorb liquids with appropriate inert absorbent. Wash away small quantities of residual material with water. Product spills may present a slipping hazard. Use caution during cleanup and flush area thoroughly with water.

Section 7 - Handling and Storage

For bulk containers and case quantities: Keep containers closed and store product at ambient temperatures away from direct sunlight. Avoid freezing or excessive heat. Avoid contacting eyes with product. For maxium efficacy do not store above 75F for extended periods of time.

Section 8 - Exposure Controls / Personal Protection

Respiratory Protection: None required
Protective Gloves: Not generally required. Wear general-purpose gloves if handling bulk product.
Eye Protection: Not normally required. Wear safety glasses or goggles if handling bulk product.
Other Protective Clothing/Equipment: None

Section 9 - Physical and Chemical Properties

Physical State: Transparent water white film       Water Solubility: Soluble

Appearance and Odor: Mint                               Boiling Point: Not determined

Odor Threshold: Not known                                Freezing/Melting Point: Not determined

Vapor Pressure: Not determined                         % Volatile: Not determined

Vapor Density (Air=1): Not determined                 Evaporation Rate: Not determined

Density: Not determined

Specific Gravity (H2O=1, at 4 °C): not determined
pH: not applicable

Section 10 - Stability and Reactivity

Stability: product is stable at room temperature in closed containers under normal storage and handling conditions.
Polymerization: Hazardous polymerization will not occur.
Chemical Incompatibilities: None known
Conditions to Avoid: None known
Hazardous Decomposition Products: None known

Section 11- Toxicological Information

Eye Effects: Non toxic but may be an irritant       Acute Oral Effects: Edible
Chronic Effects: None known
Skin Effects: Non toxic                                      Carcinogenicity: No
Mutagenicity: No
Acute Inhalation Effects: Not applicable               Teratogenicity: No

Section 12 - Disposal Considerations

Not expected to be regulated. However, any disposal practice must be in compliance with local, state and federal regulations.

Section 13 - Transportation Information

Technical Shipping Name: Dissolvable Tooth Whitening Film
D.O.T. Hazard Class: None
U.N./N.A. Number: None
Hazardous Substance/RQ: None
D.O.T. Label: None
D.O.T. Placard: None

Section 14 - Regulatory Information

USA: Product considered cosmetic in nature.
In consumer use, exempt from OSHA regulations.

Section 15 - Other Information

Prepared By: J. Lokken, C. Bowers
Revision Notes: 3

Disclaimer: This MSDS is offered solely for your information, consideration and investigation. This MSDS is intended to provide a brief summary of our knowledge and guidance regarding the use of this material. Lornamead provides no warranties, either expressed or implied and assumes no responsibility for the accuracy or completeness of data contained herein. Lornamead urges persons receiving this information to make their own determination as to the information suitability for their particular application. Consumers are to consult material included with package, which include necessary information prior to consumer use.