NCT01046812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 6, 2015

Status Verified

December 1, 2009

Enrollment Period

2.2 years

First QC Date

January 11, 2010

Last Update Submit

October 5, 2015

Conditions

Halitosis

Keywords

questionnairehalitosiscaphosolQuality of life questionnaire assessing halitosis

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Caphosol in treating Halitosis

    1 month

Secondary Outcomes (1)

  • Confirmation of QOL questionnaire as tool measuring the burden of halitosis

    1 month

Interventions

CaphosolDRUG

Caphosol 2-4 times daily oral rinse for two weeks duration minimum up to one month.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Head & Neck Institute offices

New York, New York, 10019, United States

Location

Related Publications (2)

  • 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: 16990322BACKGROUND

  • 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.

    PMID: 12847442BACKGROUND

Related Links

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 6, 2015

Record last verified: 2009-12

Locations

US(1)