antivet® kit

TECHNICAL DATASHEET
ANTIVET KIT
®
TOOTH ENAMEL CLEANSER FOR STAINS CAUSED BY FLUORO
INTRODUCTION
Dental fluorosis is a dental condition that can be found in certain geographical areas in Mexico
and the world in general. Dental fluorosis is a type of tooth staining and also a form of enamel
hypoplasia caused by environmental factors (fluoride ingestion). Dental fluorosis is endemic in
nature, in other words, it is a dental condition that affects the general population of a country or
region for temporary stages or permanently due to excessive exposure to fluoride or its
compound forms (Chronic Endemic Fluorosis).
Fluoride ingestion for long periods of time during tooth enamel formation produces a series of
changes that can range from the appearance of thin white striations on the enamel surface to
severe structural defects.
The incorporation of fluoride onto the enamel occurs in two ways: systemically or topically. The
retention of fluoride is primarily due to apatite’s ability to absorb and attach fluoride as part of its
integral crystalline structure.
This condition presents itself with the appearance of stains on the enamel surface that may be
esthetically unappealing on the patient’s teeth.
Depending on the fluoride levels and minerals present in water the stains may appear with
several color variations, including white, brown, yellow, or a combination of these.
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page1
TECHNICAL DATASHEET
ANTIVET KIT
®
The moderately to severely affected teeth may have a tendency to wear and/or fracture at the
enamel level.
History
In 1916 G.V. Black and F. McKay, described this condition for the first time as “mottled enamel”
a type of enamel hypoplasia. Although it is known that there are previous references in the
bibliography, Black and McKay discovered this lesion had a geographic distribution and
suggested it was caused by a substance contained in water; however, it was not until 1930-1940
when it was proved that the substance in question was fluoride.
Generic Name
Enamel cleansing kit
Brand
ANTIVET Kit
Instructions for use
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page2
TECHNICAL DATASHEET
ANTIVET KIT
®
The Antivet Kit solution is specially formulated to eliminate stains on the enamel surface caused
by dental fluorosis or any other external factor.
Mode of Action
The tooth’s surface is exposed to an acid solution by ionization by the fluoride absorbed in the
apatite crystals (stains). This reaction allows for the fluoride ions to separate from the fluoride
ions in the apatite crystals, forming soluble salts that are easily removed from the tooth enamel
surface. Once the stains are removed, a calcium hydroxide solution is applied to neutralize the
residual acidic solution left on the tooth surface. Lastly, the tooth is rinsed with water.
Composition
Acid Base (Antivet): It is hydrofluoric acid at a 21% concentration stabilized by an organic
tricarboxylic acid, with a controlled pH of <3, necessary to react with the fluoride ions to form
soluble salts. The organic and inorganic ions are extracted from within the fluorapatite crystals
through this ionization process which essentially allows the enamel surface to be cleansed
without damaging it.
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page3
TECHNICAL DATASHEET
ANTIVET KIT
®
Alkaline Base (Neutralizer): It is calcium hydroxide with a pH >12, which acts upon the
residual antivet solution on the tooth surface by way of a neutralizing reaction. At the same
time, the calcium hydroxide seals off the enamel prisms and/or dentinal tubules on the tooth
surface that have been uncovered by the friction of the cotton pellet.
This system and product, has been duly patented in Mexico and several other countries around
the world.
Specifications
Appearance: Clear liquid
Odor: Slightly irritatant
Flavor: Slightly acidic
Mode of absorption: None
Toxicity grade: None (If used as indicated)
Mutagenic, Carcinogenic, or teratogenic action: None
Level of accumulation or side effects: None
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page4
TECHNICAL DATASHEET
ANTIVET KIT
®
INSTRUCTIONS FOR USE
1. Isolate tooth/teeth to be treated with a Nic Tone dental dam.
•
Do not place a light cured gingival barrier.
•
Do not isolate with cotton rolls.
•
Place vaseline on gingival sulcus before placing dental dam.
•
You may isolate individually or several teeth at a time.
2. Seat patient at a 45 degree angle.
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page5
TECHNICAL DATASHEET
ANTIVET KIT
®
1.
Place 5 drops of Antivet in the plastic mixing well that comes with the kit.
2.
Apply the ANTIVET solution over the tooth’s surface using a well condensed cotton pellet
(approximately a 3 mm diameter), hold the cotton pellet with the pliers that were provided
in the kit and rub the pellet onto the surface in a sweeping motion from cervical to incisal.
3.
When the cotton pellet is pigmented by the tooth’s staining, change it for a new one,
saturate the pellet with the solution and repeat the procedure.
4.
Repeat this process until the stain is removed.
4.
This process may take about 1 to 5 minutes per tooth.
5.
It should take no longer than 15 minutes from the moment the solution contacts
the tooth’s surface.
6.
Do not reapply pigmented (stained) cotton pellets.
7.
The tooth must not be dry at any given moment, otherwise the Antivet solution will
not work properly.
8.
Before completing treatment, apply the last application with a new pellet and
make sweeping movements from the distal surface towards the midline of the
tooth.
7. Once the the tooth surface is free of stains, do NOT rinse the tooth surface. Using a dry
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page6
TECHNICAL DATASHEET
ANTIVET KIT
®
cotton pellet or gauze remove any excess solution on the enamel.
8
InaseparatemixingwelldispensetheNEUTRALIZINGSOLUTION,applythe
solutionontothetoothsurfaceusingabrushormicrobrushandletitsitfor2
minutes.Itisofutmostimportancethattheneutralizingsolutionisapplied
completelyuptothegingivalmargin.Note:Donotremovethedentaldamuntil
youhavecompletedtheprocesswiththeneautralizingagent.
Rinse.
9.
POST - OPERATIVE INSTRUCTIONS FOR THE NEXT 72 HOURS
•
Do not eat or drink food or liquid that contain food coloring (coffee, tea, beets,
etc.)
•
Do not eat any citrus or irritants.
•
Food and/or drink should be room temperature, avoid hot or cold.
•
Do not use mouthwash or toothpaste with high concentrations of food coloring or
flavor.
•
You may elect to have a tooth whitening procedure after 7 days
o
ADVANTAGES
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page7
TECHNICAL DATASHEET
ANTIVET KIT
®
o
Does not affect enamel
o
Permanent stain removal of the tooth.
o
Instant results in one dental visit.
o
Does not result in tooth sensitivity
o
Registered product with the Cofepris under ther the registration number: 2037C2015SSA
BIOCOMPATIBILITY
ANTIVET cleansing solution is not absorbed by any of mechanism in the human organism
during its application. This was proven by studies and trials during the application of the solution
onto the enamel surface; therefore, there is a null grade of toxicity pertaining to it.
There is no structural damage to the tooth or the enamel/s integrity.
Enamel wear is significantly less when compared to the alternativer enamel abrasion methods
because it is a chemical reaction that occurs during the procedure.
There are no secondary effects.
The application of ANTIVET is safe.
Teeth do not become sensitive to cold or hot stimulus during nor after treatment and there is no
gingival discomfort post-operatively.
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page8
TECHNICAL DATASHEET
ANTIVET KIT
®
STORAGE
This material has a shelf life of 36 months from the date of fabrication as long as it is maintained
in ideal conditions under storage. This material must be stored in a dry, room temperature setting,
free of contamination and away from direct sunlight in its original package.
SAFETY
ANTIVET enamel cleansing solution must not be applied over soft tissue, it could cause irritation
due to its composition.
•
If this occurs, immediately wash with a neutralizing agent (water with sodium
bicarbonate)
Do not apply on primary dentition.
Do not apply on children under age 12.
Do not apply on decayed teeth.
If the tooth presents fractures, apply adhesive and light cure. (This will give you enough time to
remove the pigmentation over the rest of the tooth’s surface without the solution penetrating
through the fracture)
Do not eat the solution, in case of accidental ingestion, immediately drink a glass of milk.
Do not provoke vomit and seek medical attention.
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page9
TECHNICAL DATASHEET
ANTIVET KIT
®
Avoid contact with the eyes. In case of accidental exposure, flush with running water, if irritation
persists, seek medical help.
Do not leave in reach of children.
This is a technique sensitive material and must be applied in a dental setting by a health
professional.
PERSONAL SAFETY EQUIPMENT
•
It is highly recommended you use gloves, face mask and safety goggles or face shield.
•
Use a long sleeve clinical gown along with close-toed shoes.
•
Patient must wear safety goggles, bib, and isolate using a Nic Tone dental dam
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page10
TECHNICAL DATASHEET
ANTIVET KIT
®
KIT CONTENTS
1 bottle ANTIVET cleansing solution - 10 ml
1 bottle MDC Dental Neutralizing solution - 10 ml
2 microbrushes
1 mixing well
1 DVD
1 Plier
Instructions manual
Manufacturera Dental Continental, S.A. de C.V.
Industria del plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page11
TECHNICAL DATASHEET
ANTIVET KIT
®
PATIENT TREATED WITH ANTIVET IN THE STATE OF GUANAJUATO (MEXICO) IN
2003, WITHOUT POST-OPERATIVE SYMPTOMS TO DATE.
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page12
TECHNICAL DATASHEET
ANTIVET KIT
®
PATIENT TREATED WITH ANTIVET FOR PUBLICATION IN MDC DENTAL S.A. DE C.V..
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page13
TECHNICAL DATASHEET
ANTIVET KIT
®
PATIENT TREATED WITH ANTIVET, HAPPY AND SATISFIED 2 YEAR AFTER
TREATMENT
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page14
TECHNICAL DATASHEET
ANTIVET KIT
®
PATIENT TREATED WITH ANTIVET IN VIVO DURING THE ANNUAL CONVENTION OF
ADD 2014
Proofread: Dr. Ignacio Pedro S.
Authorized by: APE Aseg. De Calidad D y D
Date: June 2016
Rev. No. 0
Manufacturera Dental Continental, S.A. de C.V.
Industria del Plástico 2113
Fracc. Zapopan Industrial Norte
Zapopan Jalisco México
Tel.: 01 33 3833 0333
www.dental.com.mx
Page15