HalitosisNCT01046812
Halitosis Devised Questionnaire Evaluating a New Treatment
A study testing Caphosol in people with Halitosis, run by New York Head & Neck Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Halitosis
- What is being tested?
- Caphosol
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Head & Neck Institute offices
New York, New York, 10019
About this study
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.
Read the 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.
- Conditions
- Halitosis
- Being tested
- Caphosol
- Keywords
- questionnaire, halitosis, caphosol, Quality of life questionnaire assessing halitosis
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaphosolDrug
Caphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Caphosol in treating Halitosis
Measured: 1 month
Secondary outcomes (1)
Confirmation of QOL questionnaire as tool measuring the burden of halitosis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Head & Neck Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046812
- Sponsor's protocol ID
- SLR 09-141
- Status last verified
- Dec 2009
- First submitted
- 11 Jan 2010
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16990322Koshimune 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.
PubMed 12847442
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Halitosis Devised Questionnaire Evaluating a New Treatment
- ClinicalTrials.gov ID
- NCT01046812
- Acronym / sponsor ID
- SLR 09-141
- Conditions
- Halitosis
- Keywords
- questionnaire, halitosis, caphosol, Quality of life questionnaire assessing halitosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- New York Head & Neck InstituteUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaphosolCaphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month. | Drug | – |
Primary outcome
Evaluation of Caphosol in treating Halitosis
Time frame: 1 month
1 secondary outcome
Confirmation of QOL questionnaire as tool measuring the burden of halitosis
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Background: PubMed 16990322Porter SR, Scully C. Oral malodour (halitosis). BMJ. 2006 Sep 23;333(7569):632-5. doi: 10.1136/bmj.38954.631968.AE. No abstract available.
- Background: PubMed 12847442Koshimune 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.
- New York Head \& Neck InstituteLink provided by the sponsor.
- Dr.Krespi's detailed resumeLink provided by the sponsor.
Related trials for Halitosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.
Periodontal Diseases, Oral Halitosis
Active, not recruiting
Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients
Halitosis, Periodontal Health
RecruitingPhase 2
Effectiveness of Aquamin® in Mitigating Halitosis
Healthy, Halitosis
Not yet recruiting
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Oral Malodor (Halitosis), Oral Dryness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caphosol in people with Halitosis, run by New York Head & Neck Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Caphosol in treating Halitosis (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01046812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.