Mechanical and chemical plaque control

MECHANICAL AND
CHEMICAL PLAQUE
CONTROL

27-07-05 Mechanical and chemical plaque control
2
CONTENTS
 Introduction
 Mechanical plaque control agents
 Toothbrush and Brushing techniques
 Disclosing agents
 Dental floss
 Interdental aids
 Chemical plaque control agents
 Chlorhexidene
 Quartenary ammonium compounds
 Antibiotics
 Stannous flouride
 Enzymes
 Antitartar agents
 Guidelines For Acceptance Of Chemotherapeutic Products For The
Control Of Supragingival Dental Plaque And Gingivitis
 Conclusion

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The primary and secondary factors and the relative importance of the
role of dental plaque, substrate, and the tooth

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Dental plaque
Plaque induced gingivitis
Periodontitis

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DENTAL PLAQUE
(MICROBIAL DENTAL PLAQUE)
 A highly variable entity resulting from the colonization and
growth of microorganisms on the surfaces of the teeth and
oral soft tissues and consisting of a number of microbial
species and strains embedded in an extracellular matrix,
 Clinically, plaque is found supragingivally and subgingivally as
well as on oral surfaces including restorations and oral
appliances.
 Dental plaque is a complex mixture of dense microbial
elements enmeshed within a gel-like matrix of
bacterial polysaccharides, salivary proteins, and
cellular components of the oral mucosa.

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 The precise nature, composition, and
cariogenic potential of the plaque depend on a
multiplicity of factors such as
 Microbial composition,
 Oral substrates,
 Frequency of oral clearance,
 Nature and form of the diet,
 Presence of fluoride, and other chemical factors.
 Importance of plaque control

MECHANICAL PLAQUE
CONTROL AGENTS

TOOTHBRUSH AND
BRUSHING
TECHNIQUES

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HISTORY
 Twigs of lentisk wood and aromatic twigs
 Gold tooth picks -- 3000 B.C.
 Chinese fabricated toothbrushes made with bone or ivory fitted
with natural hog bristles. 1600 A.D.
 Natural bristles made from hog's hair are usually very sharp and
unkind to soft tissues.
 These are expensive, very hard, sharp, and abrasive to both cervical
root surfaces and gingival tissues.
 Present day -- nylon bristles of varying quality, end rounded by
a polishing process, affixed to plastic handles of diverse
designs.

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DESIGN

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 Length of the head
For adult brushes –min 1 3/8 inches
For children – min 1 inch
 Width of the head
For adult brushes –min 1/2 inch
For children – min 5/16 inch

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TUFT DESIGN
Straight, multi tuft trim with three rows of bristles –most common.

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TEXTURE AND FILAMENT
 The texture of a toothbrush is determined by
 the diameter of the filament,
 the length of the exposed filament
 the size of the hole into which the filaments
comprising a tuft are inserted,
 the number of tufts in a given area, and
 the number of filaments in each
 BRISTLES TEXTURE
 Made of highest quality nylon usually 0.007 or
0.008 inches (0.1778 or 0.2032 mm) in diameter –
optimum for pedodontic patients.

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Bristle Textures Recommended
"extra-soft" brush
(6 mil)
When the gingival tissue is particularly tender and
prone to bleeding when brushed.
"soft" brush
(7 mil)
Normally for young children
medium-grade brush
(8 mil)
most preferred –as they are sufficiently stiff to
effectively remove plaque on tooth surfaces and in the
gingival sulcus.
"hard" brush When the brushing forces are heavy
Suitable for someone with heavily keratinized gingival
tissues that will withstand the stiffness.
"extra-hard"
bristles (12 mil)
Only in extremely rare instances.
Disadv -- may cause gingival damage and cervical
abrasion, resulting in gingival recession.

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SELECTION OF A TOOTHBRUSH
 Age and hand sizes
 For toddler--head should be compact and
fitted with soft end-rounded nylon so the
adult can brush the child's teeth effectively.
 For a preschooler --small brush head with a
small or long handle.
 For the child 6 to 7 years of age -- The brush
head should be small.
 For children 8-12 years of age –Medium sized
head, bristles and handle.

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Oral B (Oral-B Laboratories, lnc., Redwood City CA)
Size Recommended for
Oral B-20 small brush designed for the school child aged 6 to 9
Oral B-30 slightly larger brush designed for children aged 9 to 12
Oral B-35 specially designed for teenagers and adults with normal dentition
Oral B-40 for adults with a full complement of teeth
Oral B-60 an oversized brush

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REACH (JOHNSON & JOHNSON PRODUCTS CO., NEW
BRUNSWICK, NJ) TOOTHBRUSH, AVAILABLE IN SIX
SIZES AND TUFT-TEXTURE FIRMNESS

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 Variation in toothbrush tuft
configuration.
 Variation of toothbrush
design and configuration

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 HANDLE DESIGN.
 A bend at the junction of
the head and handle may
facilitate reaching the
distal surfaces of molars.
(Reach and Oral B)
 New diamond-head
design with bristles of
two different colors
and textures designed
to brush the smooth
surfaces and inter
sulcular spaces more
effectively.

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BUTLER GUM (JOHN O. BUTLER CO., CHICAGO, IL)
 411, 409, and 407 toothbrushes claimed to reduce gingivitis by
(I) domed-shaped bristle trim, which claimed to be able to provide a proper bristle
angle to reach deep into the gingival sulcus and between tight contacts without
the bristle "brush up" that would occur with ordinary flat-trim brushes, and
(2) tapered and rounded bristles –

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SPECIAL MODIFICATIONS
BRUSH DESIGN RECOMMENDED
Orthodontic
brushes
2 rows of longer bristles on
each side of a middle row of
shorter and stiffer bristles
to clean teeth, gingival tissues,
the orthodontic brackets, wires,
and attachments.
Special sulcular
cleansing
brushes
with a small head and softer
bristles
for the patient with periodontal
pockets.
Pacemaker 45
(Oral-B
Laboratories,
Inc.)
bristles of the brush are
automatically placed at 45°
angle to the tooth and sulcular
surfaces when held normally.
Design is aimed to facilitate the
adoption of the Bass method of
tooth brushing or other methods
of intra sulcular brushing.
Inter dental and
interproximal
brushes
for patients with bridges, partial
dentures, and fixed orthodontic
appliances.
Travelling
brushes
2 sections: assembled before
use with the brush head fitting
into the handle.

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TOOTHETTE
 A swab of sponge attached to a stick.
 USES
 As an adjunct for oral cleansing in hospitals.
 In hospitalized patients having extremely fragile and tender or
mucosal lesions.
 To deliver moisture to dried oral mucosa as well as swab clean the
oral cavity in conjunction with some topical antiseptics.

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3-PIECE TOOTHBRUSH TRAINER SET
 Contains
 2 brushes made with
ultrasoft rubber and a
very narrow and small
brush with soft bristles.
 USE
 For infants during
teething
 To introduce brushing to
the infants

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FOR THE DEVELOPMENTALLY DISABLED
 Special modifications
1. Attach toothbrush to a wide elastic strip.
2. Attach the sponge, rubber ball, or bicycle handle grip to the toothbrush
to enlarge the brush handle to an appropriate size and configuration.
3. Lengthen handle with tongue blade depressors or a plastic ruler to
improve access and manipulation.
4. Bend the handle of the toothbrush.
5. Use an electric toothbrush.

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POWERED TOOTHBRUSHES
 Three basic types of toothbrushing actions:
1) Rotation in a arc of about 60o so that the
bristles brush the teeth in a sweeping action
similar to the roll method,
2) Back and forth horizontal action as used in the
horizontal scrub method, and
3) An elliptic movement that combines oscillating
with the back and forth movements.
 Effective for plaque removal especially when
used in preschool children or by parents who
brush their children’s teeth.
 USES
 Most useful in physically handicapped or mentally
retarded children for the nursing aids who care
for them, and also
 In patients with prosthetic and orthodontic
appliances.

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 Bass Technique
 Roll Technique
 Scrub technique
 Circular Scrub Technique / Fones technique
 Modified Stillman’s Technique
 Charter’s Technique
 Physiologic Technique

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BASS TECHNIQUE
 Placement of the toothbrush
bristles at a 45° angle to the
long axis of the teeth
 Gently pressing the ends of
the bristles into the gingival
sulcus and interproximal
areas while the brush is
vibrated in a back and forth
short stroking motion.
 2-4 teeth and their
interproximal spaces
cleansed at one time.
 Occlusal surfaces brushed
using short antero posterior
strokes.

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ROLL TECHNIQUE
 Bristles placed firmly at a 45° angle on the
attached gingivae and the brush head is rolled
in a coronal direction using an arcuate motion.
 Motion is repeated systematically for the
entire oral cavity.
 Occlusal surfaces are brushed in an antero
posterior scrubbing motion.

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SCRUB TECHNIQUE
 The bristles are applied at 90° to the
tooth surface and the brush is moved
back and forth as in scrubbing a floor.

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CIRCULAR SCRUB / FONES
TECHNIQUE
 Bristles at 90°, and the entire brush head is moved in
a circular scrubbing motion using light pressure. The
spherical pathway is limited to the mucobuccal space.
 No deliberate attempts at intra sulcular cleansing is
made. This technique is said to be effective for young
children with minimal manual dexterity.

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MODIFIED STILLMANS' TECHNIQUE
 Placement of the bristles at
45° to the long axis of the
teeth on the gingival margin.
 The brush is vibrated
mesiodistally as the brush
head is rotated toward the
coronal surface.
 Technique stresses
interproximal cleansing and
the massaging effects of the
bristles on the gingival
tissues.

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CHARTER'S TECHNIQUE
 Starts with bristles
placed at a 45° angle to
the teeth, but they are
firmly pushed into the
interproximal spaces with
a slight rotary and
vibratory action.
 Main action depends on
the massaging effects of
the sides of the bristles.
 Occlusal surfaces are
brushed using a rotary
movement.

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PHYSIOLOGIC TECHNIQUE
 This method requires a soft brush and
the brushing is done by sweeping from
coronal portion apically toward the
gingival margin and the attached
gingivae similar to the pathway of food
during mastication.

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TECHNIQUES RECOMMENDED FOR
CHILDREN
 Scrub or circular scrub technique is probably best for young
children with little manual dexterity.
 Horizontal scrub is used most frequently by preschoolers and 6-
8 years old children.
 Children younger than 8 years of age should be taught a less
complex technique than sulcular toothbrushing. The scrub
technique would be more appropriate.
 Children b/w 8- 12 yrs old should be taught the sulcular
toothbrushing techniques.
 When toothbrushing is not possible or is inconvenient, children
should be taught to "swish and swallow."

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 For uncooperative toddlers, one parent should provide
support and restraint if necessary while the other
brushes the teeth with the child's head on his or her
hip.
 The parent should sit or stand behind the child and
lean the child's head back into the parent's left arm
while the right hand is used for brushing.
 Deplaquing should be done without the use of
dentifrice, and hence toothbrushing can be done in
any room where the lighting is best.
 The dentifrice may be used to impart the benefits of
fluoride and the detergent and freshening effects.

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 Toothbrushing using a fluoridated dentifrice has been shown
to consistently produce a 20% to 30% reduction in dental
caries.
 A fluoridated dentifrice is highly beneficial because it is an
effective way of delivering fluoride to the tooth surfaces.

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 Toothbrushing techniques and abilities are
not innate; they must be taught and learned.
 Supervised instructions combined with
positive reinforcement at each recall visit
should help develop more permanent and
healthy oral hygiene habits.

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 A good disclosing agent stains the teeth only very
faintly by staining the pellicle a faint pink color but
stains the dental plaque deeply and vividly.
 Agents used
 Basic fuchsin
 Erythrocin
 Fast green
 Other vegetable and food coloring dyes.
 Mode of application
 By professional personnel
 Dropped directly into the mouth and swished in the mouth
with a few drops of water, or
 Can be applied with a cotton swab directly to teeth.

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 Dis-plaque (Oral-B Laboratories, Inc.)
 Dye that differentiates plaque by
staining older plaque in blue tones and
more recent thin deposits in red tones.
This dye is designed to minimize the
staining of the soft tissues and usually
fades much faster than erythrocin

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TABLETS, CAPSULES, AND WAFERS ARE PROBABLY MORE EASILY
MANAGED BY CHILDREN AND PARENTS FOR HOME USE.

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PLAK-LITE MIRROR (LACTONA, HATFIELD, PA)
 Uses a fluorescent dye in
conjunction with a special mirror
and avoids the use of a red dye.
 Useful for adult males who object
to red staining of the lips, tongue,
and cheeks.
 Stained plaque should fluoresce as
a brilliant yellow-green color.
 Clean tooth surfaces and plaque
free gingivae not stained by the
fluorescent dye, whereas dental
plaque is seen vividly by the
fluorescent light source.
 Patient using Plak-Lite
mirror in conjunction with
a fluorescent dye to
disclose plaque to a
brilliant yellow green
colour.

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 Most valuable adjunct to mechanical plaque
control, particularly in the interproximal
tooth surfaces.
 HISTORY
 First commercial dental floss by Cod man and
Shurtleff' of Randolf Massachusetts – in 1882
 First patent on dental floss dates back to 1876.
 The Johnson & Johnson Company (New Brunswick,
NJ), manufactured silk dental flosses as early as
1898.

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DESIGN
 Made from nylon filaments.
 Usually from multiple filaments, 2 to 3 denier thick, which are
combined into an end.
 Denier (D) is best defined on the basis of the weight of a 500-
denier floss. The denier of any yarn is its weight in a 9000 m
length; thus 9000 m of 500 D yarn should weigh 500 g.)
 Each dental floss, depending on its thickness. is made with 4 to
18 ends of filaments twisted in a predetermined number of
twists per inch' (tips).
 A floss that is designed to basically serve as ties for securing a
rubber dam in place should have a high tips and wax coating,
whereas for greater splaying action to clean interproximal
surfaces of teeth, a lower tips is more desirable.

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 Waxed vs Unwaxed floss.
 wax being left on the interproximal surfaces from
waxed floss
 unwaxed floss is usually thinner and splays more on
use.
 Waxed floss is used much more in dental offices
and is recommended to those patients who do not
manage the thinner unwaxed floss well.
 Mechanical deplaquing effect of flossing is
greater than the use of a fluoride dentifrice.

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FLOSSING TECHNIQUE
 Effective use dental floss is a function of
age, manual dexterity and eye-hand
coordination.
 Not all children are able to floss effectively.
 Flossing should be done thoroughly at least
once a day.
 Flossing can either precede or follow
toothbrushing.

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FLOSSING TECHNIQUE

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Variety Of Floss Holders Or Floss Aids
• Useful to clean the interproximal surfaces
of pontics of crowns and bridges and in fixed and
removable prosthodontic or orthodontic appliances.
Techniques of Interdental flossing

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INTERDENTAL CLEANSING AIDS
 TOOTHPICK is used
extensively, particularly in
Southeast Asian countries
and Japan.
 Used essentially to dislodge
food particles and foreign
materials impacted in the
interdental areas but not
designed to cleanse
interproximal surface.

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 STIMUDENT, a soft resilient
type of wood toothpick, shaped
to fit the interdental space
used to dislodge food
particle and effectively remove
plaque interdentally.
 Stimudent or similar products does not damage
periodontal tissues and is pleasantly flavored to leave
a good taste after use.
 Various flavors and even therapeutic agents (e.g.,
fluoride) can be incorporated in the wood to enhance
patient acceptance and deliver additional protective
benefits to these Caries susceptible sites.

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CHEMOTHERAPEUTIC
AGENTS FOR THE
CONTROL OF PLAQUE,
CALCULUS, AND
GINGIVITIS

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DEAL PROPERTIES OF PRODUCTS DESIGNED
TO
CONTROL PLAQUE AND GINGIVITIS
rom Mitchell, E.: Ideal properties. J. Am. Dent. Assoc., 112:24, 1986.)
 Agent should affect only the target tissue.
 An antimicrobial agent should affect only bacteria known to cause gingivitis or
periodontitis, or both.
 An agent that alters the surface of the tooth should affect only the tooth or root
surface and not the oral mucosa.
 An enzyme or anti-metabolite should affect only the metabolic process of the plaque
bacteria for which it is intended.
 Active agents should remain at the site of the action for a time sufficient to
produce the maximum therapeutic effect, but not so long that it will produce
adverse effects.
 Agent should be safe to the oral tissues at the conc and dosage recommended.

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 Agent should be safe to ingest at a level expected with normal use that
produces the maximum therapeutic effect.
 Agent should have desirable characteristics that enhance compliance
with a preventive regimen.
 For example the agent should have acceptable flavor and mouth feel and
should not stain oral surfaces or irritate the tongue or other mucosal area.
 Ideally, the product containing the active agent should be inexpensive.
 Agent should produce an effect on plaque that will result in a
statistically and clinically meaningful reduction in gingivitis or
periodontitis, or both.

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 The clinical benefit of plaque control can best
be demonstrated by a significant reduction in
gingivitis. Therefore, it will be necessary to
demonstrate statistically significant
reduction in both plaque and gingivitis by the
products.
 Also plaque reduction per se is not an end
benefit for the consumer, rather, gingivitis
reduction is.

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 The most widely tested chemotherapeutic agents used to treat
plaque and gingivitis include antiseptics, phenolic compounds,
chlorhexidine, antibiotics, and stannous fluoride.

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CHLORHEXIDIN
E Chlorhexidine digluconate mouthrinses in conc of 0.2% to 1 %
are highly effective in inhibiting dental plaque.
 Mechanism of action
 Spectrum of activity -- gram-positive and gram-negative
bacteria and yeasts as well as Streptococcus mutans
 Can practically eliminate S. mutans from the mouth without
reappearance for atleast 11 weeks.
 The long-term use of chlorhexidine over a 24-month period
showed that Streptococcus sanguis developed slight resistance.

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 It may also be effective as an anticaries
agent.
 Chlorhexidine combined with topical fluoride
gel that may be used to combat dental caries,
gingivitis, and plaque accumulation.
 Particularly indicated for disabled persons with
limited abilities for mechanical plaque control.
 An antimicrobial varnish containing
chlorhexidine in a tincture of benzoin
(Chlorzion) eliminates S. mutans infections
for approximately 1 year without
retreatment.

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UNDESIRABLE SIDE EFFECTS OF
CHLORHEXIDINE
 A brown diffuse discoloration of the teeth, composite
restorations and the tongue,
 Unpleasant bitter taste.
 Dryness of the mouth and burning sensations of the tongue.
With high concentrations,
 Desquamation of oral epithelial cells may occur, and
hyperkeratosis and dysplasia of the mucosa have been reported
in animal studies.
 Rarely, allergic responses may also occur.
 May be toxic to submucosal tissue if applied directly on them
during surgical procedures.
 Long-term use of chlorhexidine may alter the oral ecology and may
result in an increase in calculus.

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SIDE EFFECTS OF CHLORHEXIDENE USE

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CETYLPYRIDINIUM CHLORIDE AND PHENOLIC
AND OTHER COMPOUNDS
 Quaternary ammonium compounds --
antiplaque properties.
 Other such compounds include
 Domiphen bromide,
 Mixtures of essential oils in alcohol - active
ingredients in antiplaque agents,
 Sanguinaria extract,
 Mixture of benzophenathridine alkaloids,
 zinc fluoride/hexetidine-containing mouthwash,
 An enzyme dependent mineralizing mouthwash,
alexidine,
 Fluoride and
 Iodines

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 Several commercially available mouthwashes containing
cetylpyridinium chloride as the main active ingredient are
effective antiplaque agents in conc of 0.025% to 0.05%.
 Patient acceptance of its taste and staining properties are generally
favorable.
 Ciancio recommended products that contain cetylpyridinium
chloride or phenols to patients with extensive fixed prosthesis
and/or periodontal defects that cannot be surgically corrected.
 They could be used either as a forced rinse or in a powered oral
irrigating device.
 Additionally, a regimen of systemic tetracycline may be prescribed
for those patients for whom irrigation is also recommended.

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ANTIBIOTI
CS
 Antibiotics like penicillin, tetracycline, hydrochloride, metronidazole.
and clindamycin used successfully by clinicians in conjunction with
thorough scaling, root planing, and periodontal surgery.
 For e.g. in treatment of juvenile periodontitis, the local application of
tetracycline either systemically or locally by hollow cellulose acetate
fibers delivers an effective conc of the drug in the gingival fluid.
 local applications -- short-lived results
 rebound of micro-organism occurs readily.

 Children receiving tetracyline before age 7 show severe staining of the
anterior teeth due to tetracycline incorporation into the dentine and
enamel.

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 Kanamycin, a nonabsorbable aminolyglycan with a broad spectrum
activity has been shown to reduce plaque and gingivitis when used as a
topically applied paste in institutionalized mentally retarded subjects
 Long-term use of antibiotics for plaque control is inappropriate because
of the high risk and low benefit.
 ONLY selective and carefully prescribed and monitored doses of
tetracycline and other antibiotics may have some benefits in the short-
term management of patients who fail to respond to conventional
therapy

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STANNOUS
FLUORIDE ACTIONS
 Cariostatic properties,
 Reduces dental plaque formation.
 Enhances pellicle deposition on teeth which thickens and is
stained by disclosing agent, yellow to light brown.
 Selective inhibition effect on the growth of S. mutans, but little
or no effect on Lactobacillus.
 SnF conc >125 ppm of fluoride -- bactericidal against S. mutans
about 10 ppm of fluoride -- alterations in DNA and glucan
production by S. mutans.
 Clinically, anti plaque effects of SnF related to
 frequency of use,
 concentration of the agent,
 stability of the Sn++ and F- ions in commercially available
preparations.

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 Mechanism of action
 retained in the mouth for a prolonged period after
application, and
 antimicrobial inhibition properties related to the quantity of
tin uptake by S. mutans.
For optimal antibacterial effect, critical factors are,
 pH of the SnF gel
 a pH <4 produces greater plaque inhibition than the same fluoride
conc (e.g., 0.1 % stannous fluoride) at a pH of 5 or 6.
 The plaque uptake of tin in stannous per milligram of plaque is also
related to the pH of the agent.
 the fluoride concentration,
 a SnF conc of 0.4% is much more effective than a 0.1 % or 0.04%
solution or gel.
 Commercially available SnF gel preparations differ in their
stability, as measured by the availability of the stannous ions
and percentage of fluoride ions ranging from 21% to 51% Sn++
ion and 85% to 93% F- respectively.

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 SnF used as part of adjunctive therapy in periodontal treatment
as it reduces plaque gingivitis as well as bleeding on probing in
peridontally involved patients
 SnF effective against Bacteroides melaninogenicus, subspecies
melaninogenicus and Asccharolyticus more than sodium fluoride
and acidulated-phosphate fluoride (APF)
 1.64% stannous fluoride was more effective than 0.4% stannous
fluoride or saline in reducing motile bacteria and spirochetes in
subgingival plaque in advanced periodontitis.
 Even 0.4% stannous fluoride gel showed significant reductions in
supragingival plaque and gingival bleeding after 3 to 6 months of
use with no deleterious effects.
 A stannous fluoride - chlorhexidine dentifrice has been shown to
decrease and "control" supra- and subgingival plaque bacteria.

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ENZYMES
 In mid-1970s --dextranase -- thought
to have the potential of a major
cariostatic agent -- potential to break
down long-chain polymers of dextran.
NO LONGER A CHEMOTHERAUPEUTIC
AGENT.
 A dentifrice (Zendium, Oral-B
Laboratories, Inc.) claimed that its
enzyme system is able to inhibit plaque
bacteria.

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 Mechanism of action.
 It is intended to enhance the lactoperoxidase system already present in
human saliva, and its function is to oxidize the thiocyanate (SCN-) in saliva in
the presence of hydrogen peroxide to form hypothiocyanate.
 The hypothiocyanate (OSCN-) would react with sulfhydrl groups of oral
micro-organisms, resulting in their inhibition.
 Preliminary clinical trials have shown some reduction in
plaque and gingivitis.

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ANTITARTAR
AGENTS Fluoride dentifrices claim to “control "tartar" or new calculus buildup
following professional prophylaxis.
E.g. Crest (Procter and Gamble)
 Zacherl et al tested a dentifrice formulation containing a combination
of soluble pyrophosphates,
 3.4% tetrasodium pyrophosphate,
 1.37% disodium dihydrogen pyrophosphate, and
 0.243% sodium fluoride in a silica gel.
 He found that it caused a reduction of newly formed calculus by 32%,
and had no untoward side effects on soft tissues.
 In a similar study using a dentifrice containing 3.3% soluble
pyrophosphate, a significant 26% reduction in calculus formation was
obtained.

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 Colgate has used a pyrophosphate formulation that
has shown to reduce new calculus formation by 44.2%.
 Pyrophosphates may prevent calcification by interfering with
the conversion of amorphous calcium phosphate to
hydroxyapatite.
 A 2% zinc chloride dentifrice formulation, introduced
as an effective ingredient in anticalculus dentifrices
such as Prevent (Johnson & Johnson Products, Inc.)
showed a 51% reduction in calculus.

77
 Tussing felt that
 a reduction in gingival scores as a result of
chemotherapeutics may only be an academic
exercise and has no validity in controlling
destructive periodontal disease.
 the time of application of the active ingredient in
most mouthwashes being less than 10 to 15 seconds
it has very limited clinical impact.
 Thus the need to stress the necessity of
regular professional dental care.

GUIDELINES FOR
ACCEPTANCE OF
CHEMOTHERAPEUTIC
PRODUCTS FOR THE
CONTROL OF
SUPRAGINGIVAL DENTAL
PLAQUE AND GINGIVITIS

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CLINICAL STUDIES OF SAFETY AND
EFFICACY
 The following characteristics should be included in
clinical studies of plaque/gingivitis control products:
 characteristics of the study population should represent
typical product users
 active product should be used in normal regimen and
compared to a placebo control, or where applicable, an active
control
 cross-over or parallel designed studies are acceptable
 studies should be a minimum of six months in duration
 two studies conducted by independent investigators will be
required

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 microbiological sampling should estimate plaque
qualitatively to complement indices which measure
plaque quantitatively
 plaque and gingivitis scoring and microbiological
sampling should be conducted at baseline, six
months and at intermediate time period
 microbiological profile should demonstrate that
pathogenic or opportunistic microorganisms do not
develop over the course of the study
 the toxicological profile of products should include
carcinogenicity and mutagenicity assays in addition
to generally recognized tests for drug safety

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Mechanical and chemical plaque control

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