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Clinical Trials/NCT00250289
NCT00250289
Completed
Phase 1

Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor

Hadassah Medical Organization1 site in 1 country15 target enrollmentMarch 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Halitosis
Sponsor
Hadassah Medical Organization
Enrollment
15
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
September 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • random gender, age and healthy people

Exclusion Criteria

  • used antibiotics in the last three months or suffer from systemic disease

Outcomes

Primary Outcomes

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.

Study Sites (1)

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