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Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00250289
First received: November 6, 2005
Last updated: January 5, 2010
Last verified: October 2009

November 6, 2005
January 5, 2010
March 2006
January 2008   (final data collection date for primary outcome measure)
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.
oral malodor will be mesured with a Halimeter monitor and an odor judge befor the sticker application and folowing the application every 7 minutes until the odor level would reach plateau
Complete list of historical versions of study NCT00250289 on ClinicalTrials.gov Archive Site
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Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula
Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Halitosis
  • Oral Malodor
  • Bad Breath
Device: a mucosal sticker with herbal formula
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Mizrahi B, Golenser J, Wolnerman JS, Domb AJ. Adhesive tablet effective for treating canker sores in humans. J Pharm Sci. 2004 Dec;93(12):2927-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • random gender, age and healthy people

Exclusion Criteria:

  • used antibiotics in the last three months or suffer from systemic disease
Both
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00250289
191055HMO-CTIL
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Hadassah Medical Organization
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Principal Investigator: Michael Perez Davidi, DMD Hadassah Medical Organization
Hadassah Medical Organization
October 2009

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