Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 7:34 AM
Study NCT ID:
NCT01046812
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2010-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Halitosis Devised Questionnaire Evaluating a New Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-11', 'releaseDate': '2019-09-22'}], 'estimatedResultsFirstSubmitDate': '2019-09-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Caphosol in treating Halitosis', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Confirmation of QOL questionnaire as tool measuring the burden of halitosis', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['questionnaire', 'halitosis', 'caphosol', 'Quality of life questionnaire assessing halitosis'], 'conditions': ['Halitosis']}, 'referencesModule': {'references': [{'pmid': '16990322', 'type': 'BACKGROUND', '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.'}, {'pmid': '12847442', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://nyhni.org/', 'label': 'New York Head \\& Neck Institute'}, {'url': 'http://nyhni.org/faculty/yosef_krespi/index.html', 'label': "Dr.Krespi's detailed resume"}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDue 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.\n\nWe intend to treat halitosis with a novel approach targeting mouth dryness- when other factors were ruled out by measuring outcome on the halitosis questionnaire.\n\nWe 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.\n\nQuality 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.\n\nTreating 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.\n\nCaphosol 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients complaining of halitosis\n* Patients over 18\n* Patients with dry mouth as seen on physical examinations\n* Patients that may be suffering from Sjogren's syndrome will be screened by SSB/La blood test.\n\nExclusion Criteria:\n\n* Patients without any other noted causes contributing to halitosis.\n* Patients restricted to a low sodium diet without specific permission from the treating physician.\n* Patients not wishing to participate in the study will be asked to fill the questionnaire regardless"}, 'identificationModule': {'nctId': 'NCT01046812', 'briefTitle': 'Halitosis Devised Questionnaire Evaluating a New Treatment', 'organization': {'class': 'OTHER', 'fullName': 'New York Head & Neck Institute'}, 'officialTitle': 'Halitosis Devised Questionnaire Evaluating a New Treatment', 'orgStudyIdInfo': {'id': 'SLR 09-141'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Caphosol', 'type': 'DRUG', 'description': 'Caphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Head & Neck Institute offices', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Head & Neck Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Victor Kizhner', 'oldOrganization': 'SLLR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-09-22', 'type': 'RELEASE'}, {'date': '2019-10-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'victor kizhner, MD, New York Head & Neck Institute'}}}}