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Halitosis Devised Questionnaire Evaluating a New Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by New York Head & Neck Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
New York Head & Neck Institute
ClinicalTrials.gov Identifier:
NCT01046812
First received: January 11, 2010
Last updated: July 21, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention
Halitosis
Drug: Caphosol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Halitosis Devised Questionnaire Evaluating a New Treatment

Resource links provided by NLM:


Further study details as provided by New York Head & Neck Institute:

Primary Outcome Measures:
  • Evaluation of Caphosol in treating Halitosis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Confirmation of QOL questionnaire as tool measuring the burden of halitosis [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Caphosol
    Caphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046812

Contacts
Contact: Victor Kizhner, MD 2122624444 vkizhner@gmail.com
Contact: Yosef Krespi, MD hnsg@aol.com

Locations
United States, New York
New York Head & Neck Institute offices Recruiting
New York, New York, United States, 10019
Principal Investigator: Victor Kizhner, MD         
Sub-Investigator: Yosef Krespi, MD         
Sponsors and Collaborators
New York Head & Neck Institute
  More Information

Additional Information:
Publications:
Responsible Party: Victor Kizhner, SLLR
ClinicalTrials.gov Identifier: NCT01046812     History of Changes
Other Study ID Numbers: SLR 09-141
Study First Received: January 11, 2010
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York Head & Neck Institute:
questionnaire
halitosis
caphosol
Quality of life questionnaire assessing halitosis
Caphosol

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014