Frequently Asked Questions
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Do dentists or hygienist need special
certification or course to be able to operate the Periowave system?
Periowave is a Class II medical device.
When used under normal operating conditions (i.e. with the light guide in place)
the laser classification is 2M. Under handpiece light path testing the laser emits
at a Class 3B level
The Periowave diode laser is different
than most diode lasers used in dentistry today. Most dental lasers are meant to
be cutting surgical lasers. These lasers are almost all Class IV lasers due to their
high power. The Periowave laser is a non-thermal laser which does not heat tissue
since its mechanism of action is by the specific wavelength of light causing a specific
reaction process.
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What is a treatment site?
Treatment sites are all probing sites
demonstrating bleeding on probing, pocket depths 4mm and greater,and loss of clinical
attachment levels. Optimal results have been noted in periodontal pocket defects
which probe 4-9 mm and in peri-implantitis lesions with bleeding, erythema and suppuration
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What type of laser is used in Periowave
treatment? Does it generate heat and will my patients feel anything during treatment?
Periowave is a Class II medical device
which incorporates a Class 3B laser.
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What are the indications of Periowave?
Periowave is used to treat:
Gingivitis- characterized by inflamed, reddened gums,
and bleeding with brushing and flossing. There may or may not be associated periodontal
disease present.
Mild Periodontitis- characterized by bleeding on probing, pocket
depths of 3-4 mm, localized areas of recession, no tooth mobility and no bone loss.
Moderate Periodontitis- characterized by bleeding on probing, pocket
depths of 4-6 mm, may have tooth mobility, bone loss may be present.
Advanced Periodontitis- characterized by bleeding on probing, pocket
depths of greater than 6 mm, has tooth mobility, and has bone loss.
Peri-implantitis- characterized by implants with surrounding
tissue showing evidence of inflammation. There may also be increased probing depths
around the implant along with associated bone loss as evidenced by visible implant
threads.
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What clinical results can I expect
to see after using Periowave?
Periowave™ clinical outcomes include
a reduction in pocket depth, an increase in clinical attachment level, a decrease
in bleeding on probing and an improvement in gingival tissue tone and texture. Periowave
treated patients have also been noted to have an overall improved whole mouth effect
even at untreated sites. For more information please see Clinical Study Result (link to Clinical Studies) and Case Studies (link to Case Studies)
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What’s in the photosensitizer
solution?
The Periowave photosensitizer is a proprietary
solution. The main ingredients include a phenothiazine dye (methylene blue), pH
stabilizers, taste enhancers
and mucoadhesive polymers. The Periowave laser and photosensitizing solution are
carefully designed to work together, and other diode lasers or photosensitizers
will not produce the same photosensitizing effect or clinical results.
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How long is the Photodisinfection
technology of PDD being used in Canada?
Periowave was launched in Canada in
March 2006.
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Is Periowave available in the US
or Europe?
Ondine Biopharma Corp is currently seeking
FDA approval to distribute in the United States. Periowave has been approved for
sale in Europe since June 2006.
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Can Periowave be used on patients
that smoke?
Periowave is certainly a good treatment
for smokers as they frequently have a particular need for additional therapy to
prevent further deterioration of their periodontal disease. There is no contra-indication
of Periowave to treat “smokers”. However, clinical response may be enhanced
in this group by several Periowave treatment sessions.
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Where can I purchase Periowave?
Periowave is being distributed by the
leading dental suppliers in Canada including Henry Schein Ash Arcona, Patterson
Dental and Sinclair Dental. For more details, you can contact our Customer Service
representative at 1-866-669-0555 ext. 240 or see “Distributors” (Link to distributors).
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Will Periowave stain?
Since the photosensitizer is a bacterial
stain (dye) it can stain clothing and care should be taken to avoid getting on clothes.
There may be a very transient blue stain
to mucosal surfaces. This resolves within a few minutes.
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Should the patient be retreated?
Clinical studies show that by repeating
a Periowave treatment within a few weeks the patient can up to an 80% improvement
over a single treatment as measured by probing depths and attachment level.
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How much photosensitizer should be
used at each treatment site?
Unless the bacteria are stained with
the dye the treatment effects will not be optimal therefore generous flooding of
the pocket is advisable to ensure complete contact with all bacterial surfaces.
On an average basis this requires approximately 0.2 ml per site.
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Should Periowave only be used on
moderate to severe periodontitis patients?
Using Periowave earlier in the disease
process will provide the optimal result for the patient. Waiting until probing depths
are excessive or there is overt evidence of bone loss will make the ultimate recovery
longer and require additional therapies.
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Are there other risk factors to consider
in patient selection?
Besides the typical indicators mentioned
above, certain patients may be at increased risk for rapid progression of their
disease so factors such as diabetes, chronic illnesses, immunocompromised patients,
long-term steroid use, auto-immune conditions should all be considered and clinical
judgment used.
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What are Periowave’s contraindications?
In many thousands of cases performed
there have been no known drug interactions with Periowave. There is a theoretical
risk for patients with severe G6PD but since Periowave is not ingested this would
be extremely unlikely to cause a reaction. Periowave is not contraindicated in pregnancy.
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Can Periowave used to treat other
conditions?
Periowave has been used to treat other
conditions however since Health Canada has not evaluated Periowave for these we
cannot promote it’s use. If you have a specific question please contact our
medical affairs department and we will be pleased to provide additional materials
to you.