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Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula
This study is currently recruiting participants.
Study NCT00250289   Information provided by Hadassah Medical Organization
First Received: November 6, 2005   Last Updated: August 3, 2008   History of Changes

November 6, 2005
August 3, 2008
March 2006
 
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
 
 
 
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

Phase I
Interventional
Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
  • Halitosis
  • Oral Malodor
  • Bad Breath
Device: a mucosal sticker with herbal formula
 
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 National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
15
September 2008
 

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: Michael Perez Davidi, DMD +972543113780 michaelpd@hadassah.org.il
Contact: Shada Nuas, BaSc +972509809865
Israel
 
NCT00250289
 
191055HMO-CTIL
Hadassah Medical Organization
 
Principal Investigator: Michael Perez Davidi, DMD Hadassah Medical Organization, Jerusalem, Israel
Hadassah Medical Organization
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP