Sponsor : LEBALAB INC.
3560 Pine Grove Ave, Suite 165
Port Huron, MI 48060 U.S.A.
LEBALAB INC.
2-1200 London Rd
Suite#261
Sarnia, On. N7S 1P4
Canada
Telephone: (519) 542-3165
Fax: 542-5196
Trade name: LEBA III
Component: Distilled water, Ethyl Alcohol (25%)
Rosaceae and Lamiaceae may be found in
trace elements.
All components are non toxic and will cause
no adverse side effects when used as
directed.
For cleaning teeth of dogs.
DOSAGE FORM: A number from 4 to 8 drops of LEBA III in 1cc of
water given orally with plastic syringe .
ROUTE OF ADMINISTRATION: Oral
RECOMMENDED DOSAGE:
Pets under 14kg (30lbs) 4 to 6 drops
Pets between 14kg (30lbs) to 22kg (50lbs) 6 to 8 drops
Pets weighing 22kg (50lbs) and over 8 drops
FREQUENCY:
Twice a week (tuesday and friday) for:
- Young dogs or cats beginning to show evidence of plaque
- Animals with plaque and calculus with periodontal condition
not requiring major medical intervention
- After teeth cleaning. To maintain clean teeth longer and to
provide dental hygiene
Daily for a period of 4 to 6 weeks
- Animals with heavy tartar
PREPARATION: Dog or cat should have no food or water 1/2
hour before and 1/2 hour to 1 hour after taking LEBA III dose .
* Tap water suitable for drinking, bottle water or
distilled water may be used for mixing LEBA III .
ADMINISTRATION: Administration of dose with syringe is
recommended;
- achieving a better concentration of LEBA III
- permits monitoring of the food and water intake of animal .
- Young dogs or cats beginning to show evidence of plaque
- Animals with plaque and calculus with periodontal condition
not requiring major medical intervention
- Animals having difficulties with anesthetics because of age,
medical condition or genetic ie: brachycephalic skull type
- Animals receiving a periodontal cleaning. To maintain clean
teeth longer and to provide dental hygiene
The animals receiving LEBA III show a reduction of plaque
tartar and calculus .A reduction of gum inflammation was
recorded and a general improvement of periodontal condition .
A. Pivotal Studies
1) Dose Response Field Trial
a) Type of study
This trial was a double blind controlled field
trial to determine the extent of periodontal
improvement on subjects receiving doses of LEBA III
twice a week.
b) Names and addresses of independent veterinarians
Performing examinations and documenting
periodontal conditions before and after double
blind tests:
Wayne Foster DMV
Blue Cross Animal Hospital
1438 London Rd
Sarnia, Ontario, Canada .
Selecting the recipients of placebo/LEBA III and
comparing and evaluating dental examinations for
the periodontal changes:
James C. Harvey DMV
Blue Cross Animal Hospital
1438 London Rd
Sarnia, Ontario, Canada .
c) Design of investigation
Dogs and cats age 1 to 6, size: small, medium and
large . Periodontal conditions were documented in
written examinations and photographs were taken
before testing. The dogs were assigned placebo or
LEBA III by Dr Harvey, Blue Cross Hospital and
witnessed by Walter Duberry of LEBALAB INC.
Dr Harvey verified that the bottles containing
placebo and LEBA III were identical with no
recognizable differences .
At the time of administration of dose 1cc of
distilled water was used for dilution to
maintain consistency of dose .
The dogs/cats received no food or water 1/2 hr
before treatment and received no food or water
1/2 hr to 1 hr after treatment .
The dogs and cats were fed their regular dry dog
food and did not vary their regular diet .No dental
treatments other than LEBA III were given to the
dogs and cats .
Placebo contained 45% Isopropyl Alcohol .
LEBA III contained 45% Isopropyl Alcohol+herbal
mixture .
Frequency: twice a week, tuesday and friday
Dose: small dogs/cats = 4 drops in 1cc of water
medium dogs = 6 drops in 1cc of water
large dogs = 8 drops in 1 cup of water
The LEBA III and the placebo were provided in
coded and identical bottles so that regardless of
group assignment the drops administered were the
same .
Wayne Foster DMV, who performed the examinations
and Lise Gu‚rin, who administrated the doses
remained blind to the identity of the dose groups .
Original treatment was administered twice a
week for 15 weeks (30 doses) .
Wayne Foster DMV performed dental examinations
after treatment .
d) Side effects
Health of dogs and cats was monitored by owner and
veterinarians .Several litters were born while
under treatment with no adverse side effects to the
bitch or puppies. Gestation and delivery was
normal.
e) Results
All the dogs and cats receiving LEBA III responded
to treatment. The dental examinations showed
improvements from slight to marked .A reduction
of plaque, tartar, and calculus, was observed as
well as improved gum pathology .
* LEBA III:
1 dose, twice a week for 15 weeks
totalling 30 doses:
The younger dogs showed a marked reduction of
plaque and calculus, less gum inflammation and a
general periodontal improvement .
Older dogs/cats with heavy tartar and calculus and
gum inflammation showed a mild reduction of plaque
and calculus .
!! BERTIE received 8 drops of LEBA III in 1 cup of
well water .We found after the trial that the
water was not recommended for human consumption
containing high minerals .
!! CATS did not accept readily LEBA III in
Isopropyl Alcohol so compliance was not complete .
LEBA III in Ethyl alcohol is virtuality tasteless.
* PLACEBO:
1 dose, twice a week for 15 weeks
totalling 30 doses:
All dogs and cats showed an increase in the
amount of plaque and calculus and some gum
inflammation .
f) Observations
We noticed that the plaque and calculus often
began to disappear at the gum line .On some
animals the plaque and calculus came off in
flakes, on others the plaque and calculus
softened, turned grey and then came off .
We observed that during the heat and gestation
period some plaque/tartar reappeared .At the
end of those periods the tartar disappeared with
regular treatment of LEBA III .
1) Dose Response Field Trial
a) Type of study
This field trial was to determine the extent of
periodontal improvement on subjects treated daily
with LEBA III and to determine the length of
treatment needed to achieve the periodontal
improvement .This was not a double blind study .
b) Names and addresses of independent veterinarians
and participating kennels
Comparing and evaluating the periodontal
improvement:
James C. Harvey DMV
Blue Cross Animal Hospital
1438 London Rd
Sarnia, Ontario, Canada .
Performing examination and documenting
periodontal condition before and after field
trial:
Wayne Foster DMV
Blue Cross Animal Hospital
1438 London Rd
Sarnia, Ontario, Canada .
Owners of the animals and
administrators of LEBA III doses:
Marg Kedwell
Kedwell Kennels
Petrolia, Ontario, Canada .
Linda Brugma
Jer-Lin Kennels
Forest, Ontario, Canada .
c) Design of investigation
Dogs with heavy tartar and calculus .Dogs who were
recipients of placebo and dogs who showed a mild
improvement on a by-weekly treatment of LEBA III .
Wayne Foster DMV documented the periodontal
conditions in written examinations and
photographs were taken at that time by Lise Guerin
from LebaLab Inc. .
LEBA III doses were administered by the dog owner
and confirmed daily by telephone to a LEBALAB
employee .
The dogs received no food or water 1/2 hr
before treatment and received no food or water
1/2 hr to 1 hr after treatment .
The dogs were fed their regular dry dog food and
did not vary their regular diet .No dental
treatments other than LEBA III were given to the
dogs .
The dogs were given a daily dose of LEBA III .
Each dog received the same number of drop doses as
in the previous double blind test, 4 to 6 drops .
Each dose was mixed in 1 cc of local tap water .
Dental examinations were performed after testing by
Wayne Foster DMV, Blue Cross Hospital .
The dental exams were compared and evaluated by
James C. Harvey DMV, Blue Cross Hospital .
d) Side effects
Health of dogs and cats was monitored by owner and
veterinarians .Several litters were born while
under treatment with no adverse side effects to the
bitch or puppies. Gestation and delivery was
normal.
e) Results
The dogs showed a marked response .The dental
examinations showed that heavy tartar and calculus
was removed almost completely on some dogs, a
tremendous improvement of dental pathology was
registered on every dog treated with LEBA III .
The owner of Jose reported that he was too
rambunctious to treat .Jose showed no improvement .
The dogs receiving a daily dose of LEBA III:
1 dose, daily for 4 and 5 weeks
totalling 28 and 35 doses:
f) Observations
We noticed that the plaque and calculus often
began to disappear at the gum line .On some
animals the plaque and calculus came off in
flakes, on others the plaque and calculus
softened, turned grey and then came off .
We observed that during the heat and gestation
period some plaque/tartar reappeared .At the
end of those periods the tartar disappeared with
regular treatment of LEBA III .
100% of the animals treated showed improvements.
The effectiveness of LEBA III is supported by data gathered at the double blind trials and the field trials .
These data reveal that when LEBA III is used according to directions set forth in labelling, it is safe and effective treatment .
A) Package Insert: Instruction sheet on the care , preparation and administration of product
B) Container label .
A) Leba III is now available in a spray bottle:
1. Easier to administer: no mixing necessary
2. Compliance improved: faster treatment for pets & owners
3. Effectiveness : 100% of the animals treated showed improvements.