Sponsor : LEBALAB INC.
2-1200 London Rd
Suite#261
Sarnia, On. N7S 1P4
Canada
Telephone: (519) 542-3165
Fax: 542-5196
Test Protocol designed by Herald Pook DVM, Head of Veterinary Dentistry, Guelph University, Guelph, Ontario, Canada
Animal selection for placebo group and Leba III group by James C. Harvey DMV, Blue Cross Hospital
Evaluation of tests by James C. Harvey DMV, Blue Cross Hospital, 1438 London Rd.,Sarnia, Ontario, Canada
Dental examinations by Wayne Foster DMV, Blue
Cross Animal Hospital, 1438 London Rd.,Sarnia, Ontario, Canada
Trade name: LEBA III registered in Canada, USA, Japan
Component: Distilled water, Ethyl Alcohol (25%)
Herbal compound: Rosaceae(Rose) and Lamiaceae(Mint)
All components are non-toxic and will cause no adverse side effects when used
as directed.
* 45% Isopropyl Alcohol was used during the tests. It was replaced by Ethyl Alcohol (25%) to facilitate acceptance. The alcohol is a stabilizer, not an active ingredient. The results have remained consistent with the tests with Ethyl Alcohol (25%).
* Delivery during the tests was with syringe. Leba III now comes in a spray which is easier for the pet owner. The eye dropper or syringe is an alternative delivery.
2. INDICATION FOR USE:
For cleaning teeth of dogs.
- 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 genetics ie: brachycephalic skull type
- Animals receiving a periodontal cleaning. To maintain clean
teeth longer and to provide dental hygiene
The animals receiving LEBA III showed 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) DOUBLE BLIND TRIALS
Dose response in double blind 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 James C. Harvey DMV, Blue Cross Hospital and
witnessed by Walter Duberry of LEBALAB INC.
James C. Harvey DMV verified that the bottles containing
placebo and LEBA III were identical with no
recognizable differences .
Administrators of LEBA III doses during double blind trials:
Lise Guérin
Director of LebaLab Inc.
1226 Murphy Rd.,Suite 22024 Sarnia, Ontario, Canada .
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
code and in identical bottles so that regardless of
group assignment the drops administered were the
same .
Wayne Foster DMV, who performed the examinations
and Lise Guérin, who administered 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
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. Dilution may have been
too great
with in 1 cup of
water and reduced efficacy.
!! CATS did not readily accept LEBA III in
Isopropyl Alcohol, so compliance was not complete .
LEBA III in Ethyl alcohol is more readily accepted.
* 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 on subjects treated with Leba III
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 during field trials:
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 bi-weekly treatment of LEBA III .
Wayne Foster DMV documented the periodontal
conditions in written examinations and
photographs were taken at that time by Lise Guérin
from LebaLab Inc. .
During field trials 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 .
* for consistent results distilled water should be used
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 succesfully 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 a 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.
Eye dropper provided for alternative delivery, on cats, small dogs or difficult pets.
Advantages:
1. Easier to administer: no mixing necessary.
2. Compliance improved: faster treatment for pets & owners.
3. Effectiveness : 100% of the animals treated showed improvement.
11: Leba III has been in use since 1994
Some observations from veterinarians and pet owners:
- Effectiveness: Consistently with the studies. Since 1995 results have been repeated on thounsands of dogs and cats. Quicker results are obtained with increased frequency of 2 treatments per day. No dilution or minimal dilution with distilled water, gives best results.
Recommended: During the study the maximum treatment that the pets received was one treatmentper day. In 1995 Leba Lab Inc. recommends 2 treatments per day until the teeth became all clean, then 1 per day for maintanance. The results are faster and more satisfactory to the pet owner with no side effects on a normal healthy pet.
- Interference:
* Antibiotics, antibacterial agents nullify the action of Leba III.
Recommendation: Do not use antibiotics or antibacterial products simultaneously. Do not use other dental products with Leba III. If antibiotics or antibacterial products have been used, expect a slower performance of Leba III.
* Well water: highly mineralized well water seems to promote build-up faster than Leba III can remove it, resulting in minimal improvement.
Recommendation: use treated water, acceptable for human consumption or bottled spring water.
Brushing is not necessary with Leba III. When desired LebaLab Inc. recommends putting only water on the brush. Baking soda can be used once in a while as an abrasive.
- Caution:
* With existing liver, pancreas, kidney disease or any condition with difficulties in metabolizing alcohol.
Recommendation: dilute with equal amounts or up to 1cc of distilled water.
* With existing digestive problems, some pets on special diets meant to prevent diaharea, may experience an increased rate of digestion and a release of unevacuated, slow digested food may occur, resulting in more stool.
Recommendation:start treatment slowly, maybe twice a week until the pet's system is accustomed to Leba III, then increase frequency slowly until Leba III is well accepted and pet can take the appropriate dosage.
Keep Leba III at room temperature, away from direct sunlight.
Give pet no water, no food or anything that could dilute Leba III,
1/2 hr before and 1/2 hr after treatment. Prevent grooming after
treatment so that Leba III will remain in the mouth.
For best results use no other dental products while using Leba III.
If you wish to brush your pet's teeth use only water on the toothbrush.
ADMINISTRATION:
Spray Leba III in the pet's mouth,on the tongue area. Leba III will mix with
the saliva,
and all the teeth and gums will receive treatment.
QUANTITY:
- pets under 22kg/50lbs : 1 spray per treatment
- pets over 22kg/50lbs : 2 sprays per treatment
FREQUENCY:
To clean teeth initially give treatments twice a day, morning and night. It
will
take more or less time depending on the breed, age and genetics. You should
see
improvement in 4 to 6 weeks but continue twice a day until the teeth are all
clean.
Then proceed with the maintenance program.
MAINTENANCE PROGRAM:
Every pet has a different chemistry & their maintenance schedule will vary.
After the initial cleaning, space out the treatments gradually, until you find
the necessary
frequency for your pet. Some pets will require daily treatment while others
may require less often.
If the tartar comes back increase the frequency.
INGREDIENTS:
Distilled water, Ethyl alcohol 25%, Lamiaceae and Rosaceae
Each bottle contains approximately 240 sprays.
Eye dropper or syringe from the plastic cap :
- Spray in the plastic cap.
QUANTITY:
- pets under 22kg/50lbs : 1 spray per treatment
- pets over 22kg/50lbs : 2 sprays per treatment
- Pick up the liquid with eye dropper or a syringe (no needle) and put it in the mouth, on the tongue.