Clinical Trial: Halitosis Devised Questionnaire Evaluating a New Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Halitosis Devised Questionnaire Evaluating a New Treatment
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 Summary:
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 question
Sponsor: New York Head & Neck Institute
Current Primary Outcome: Evaluation of Caphosol in treating Halitosis [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Confirmation of QOL questionnaire as tool measuring the burden of halitosis [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: New York Head & Neck Institute
Dates:
Date Received: January 11, 2010
Date Started: September 2009
Date Completion:
Last Updated: October 5, 2015
Last Verified: December 2009
