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Halitosis Devised Questionnaire Evaluating a New Treatment

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caphosol
Sponsored by
New York Head & Neck Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis focused on measuring questionnaire, halitosis, caphosol, Quality of life questionnaire assessing halitosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Head & Neck Institute offices

Outcomes

Primary Outcome Measures

Evaluation of Caphosol in treating Halitosis

Secondary Outcome Measures

Confirmation of QOL questionnaire as tool measuring the burden of halitosis

Full Information

First Posted
January 11, 2010
Last Updated
October 5, 2015
Sponsor
New York Head & Neck Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01046812
Brief Title
Halitosis Devised Questionnaire Evaluating a New Treatment
Official Title
Halitosis Devised Questionnaire Evaluating a New Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
New York Head & Neck Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
questionnaire, halitosis, caphosol, Quality of life questionnaire assessing halitosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Caphosol
Intervention Description
Caphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month.
Primary Outcome Measure Information:
Title
Evaluation of Caphosol in treating Halitosis
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Confirmation of QOL questionnaire as tool measuring the burden of halitosis
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
New York Head & Neck Institute offices
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16990322
Citation
Porter SR, Scully C. Oral malodour (halitosis). BMJ. 2006 Sep 23;333(7569):632-5. doi: 10.1136/bmj.38954.631968.AE. No abstract available.
Results Reference
background
PubMed Identifier
12847442
Citation
Koshimune S, Awano S, Gohara K, Kurihara E, Ansai T, Takehara T. Low salivary flow and volatile sulfur compounds in mouth air. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Jul;96(1):38-41. doi: 10.1016/s1079-2104(03)00162-8.
Results Reference
background
Links:
URL
http://nyhni.org/
Description
New York Head & Neck Institute
URL
http://nyhni.org/faculty/yosef_krespi/index.html
Description
Dr.Krespi's detailed resume

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Halitosis Devised Questionnaire Evaluating a New Treatment

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