Halitosis Devised Questionnaire Evaluating a New Treatment



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2009
End Date:December 2011

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The investigators propose a novel assessment of oral malodor (halitosis) by a quality of
life (QOL) questionnaire designed specifically for halitosis and a new treatment for
halitosis by improvement of mouth dryness.

Halitosis is a common symptom which can affect people of all ages. It may decrease self
confidence and social interactions. Oral halitosos is the consequence of microbial (mainly
Gram negative bacteria) breakdown of food debris, cells, saliva, and blood. The agents that
give rise to halitosis include especially the volatile sulphur compounds (VSC), diamines,
and short chain fatty acids of which only the VSC can be detected in the clinical setting,
making the detection of halitosis often very hard. The most common cause for oral halitosis
is poor oral hygiene due to gingivitis or periodontitis. Other causes include bacterial
accumulation on the posterior tongue, tonsillitis and others. Dry mouth has been implicated
as a potential cause in halitosis.

Due to the lack of quantitative objective measuring to the severity of halitosis and
especially in the face of the subjective nature of halitosis as occurs commonly a
subjectively measurement is necessary. As no current QOL exists for measurement of halitosis
formulation of such a questionnaire can enable a measurement of subjective halitosis with
change observed over time or with intervention.

We intend to treat halitosis with a novel approach targeting mouth dryness- when other
factors were ruled out by measuring outcome on the halitosis questionnaire.

We will treat mouth dryness with Caphosol- a solution indicated for mouth dryness acting
only locally after mouth washing. As this is a supersaturated phosphate solution of a
mineral not alien to the body side effects are practically negligible.

Quality of life (QOL) questionnaires (such as SNOT20- sinonasal outcome test) are common in
medicine, however no such questionnaire exists for halitosis. We devised a specific QOL
questionnaire for halitosis. This questionnaire consists of 20 questions covering functional
limitation, physical discomfort, psychological discomfort, physical disability and social
disability. The answers will be based on a common scale of 5 answers depending on the
severity and ranging from a never bothering symptom to a symptom which as worse as can be.
Formulation of this a questionnaire can assist in measuring subjective halitosis with change
observed over time or with intervention.

Treating halitosis is a challenge due to the multitude of factors. However, some treatments,
mainly in the form of nasal saline irrigation or oral solutions chlorine based or triclosan
exist. Mouth dryness, although implicated as a factor, has not been targeted yet. Improving
salivary flow may reduce the stasis of saliva thus reducing the concentration of proteins
that bacteria dwell on as well as a better degradation of oral food debris.

Caphosol is a topical oral agent of supersaturated calcium phosphate rinse indicated for dry
mouth that has been clinically proven to shorten the duration and severity of mucositis and
relieve dry mouth when used with fluoride. Caphosol is indicated for dryness of the mouth or
throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the
conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard
oral care in treating the mucositis that may be caused by radiation or high dose
chemotherapy. It has an extremely high safety profile as these salts are not alien to the
body, thus if swallowed accidentally, no adverse effects are expected. No known drug
interactions exist.

Inclusion Criteria:

- Patients complaining of halitosis

- Patients over 18

- Patients with dry mouth as seen on physical examinations

- Patients that may be suffering from Sjogren's syndrome will be screened by SSB/La
blood test.

Exclusion Criteria:

- Patients without any other noted causes contributing to halitosis.

- Patients restricted to a low sodium diet without specific permission from the
treating physician.

- Patients not wishing to participate in the study will be asked to fill the
questionnaire regardless
We found this trial at
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New York, New York 10019
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