Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor |
- 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) |
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| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Israel | |
| Hadassah Medical Organization, | |
| Jerusalem, Israel, 91120 | |
| Principal Investigator: | Michael Perez Davidi, DMD | Hadassah Medical Organization |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00250289 History of Changes |
| Other Study ID Numbers: | 191055HMO-CTIL |
| Study First Received: | November 6, 2005 |
| Last Updated: | January 5, 2010 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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 |
ClinicalTrials.gov processed this record on May 19, 2013