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Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250289
First Posted: November 8, 2005
Last Update Posted: January 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would prevent oral malodor if delivered in an appropriate delivery system to enable slow release of the active ingredients.

Condition Intervention Phase
Halitosis Oral Malodor Bad Breath Device: a mucosal sticker with herbal formula Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Oral malodor will be measured with a Halimeter monitor and an odor judge before the sticker application and following the application every 7 minutes until the odor level would reach plateau.

Estimated Enrollment: 15
Study Start Date: March 2006
Study Completion Date: September 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:
Oral malodor (Halitosis, Fetor ex ora) is a common and disturbing condition, affecting according to some studies about one quarter of the population. This condition may start at any time from early childhood through adolescence, adulthood and old age and vary in character and severity.The bacteria responsible for malodor production are for the most part Gram negative oral bacteria (2- 4) such as Porphyromonas gingivalis, Fusobacterium nucleatum and Prevotella intermedia. These bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. Some of these amino acids (e.g. methionine, cysteine, tryptophan, lysine) are further metabolized yielding malodorous volatile products such as methylmercaptan, hydrogen sulfide, indole, skatole and cadaverine (5-7). These are foul smelling compounds, which are released during exhalation and speech.in our study we intend to use an aprooved mucosal sticker containing carbopol and hydroxypropylcellulose mixed with the herbal ingredients and placed on the palatal mucosa.than mesure the volatile sulfur compounds to observe if the composition has antimalodor effect and for how long. the herbal ingredients are used for many years for medicinal and nutritional purposes. if our hypothesis is right we might have another formulation and method of application to prevent oral malodor
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • random gender, age and healthy people

Exclusion Criteria:

  • used antibiotics in the last three months or suffer from systemic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250289


Locations
Israel
Hadassah Medical Organization,
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael Perez Davidi, DMD Hadassah Medical Organization
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00250289     History of Changes
Other Study ID Numbers: 191055HMO-CTIL
First Submitted: November 6, 2005
First Posted: November 8, 2005
Last Update Posted: January 6, 2010
Last Verified: October 2009

Keywords provided by Hadassah Medical Organization:
malodor
halitosis
herbal formulation
natural medicinals
slow release delivery system

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms