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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00250289 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor |
Estimated Enrollment: | 15 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | September 2008 |
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
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Perez Davidi, DMD | +972543113780 | michaelpd@hadassah.org.il |
Contact: Shada Nuas, BaSc | +972509809865 |
Israel | |
Hadassah Medical Organization, | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: : Arik Tzukert, DMD : 00 972 2 6776095 arik@hadassah.org.il | |
Contact: Hadas Lemberg, Phd 00 972 2 6777572 : lhadas@hadassah.org.il | |
Principal Investigator: Michael Perez Davidi, DMD |
Principal Investigator: | Michael Perez Davidi, DMD | Hadassah Medical Organization, Jerusalem, Israel |
Study ID Numbers: | 191055HMO-CTIL |
Study First Received: | November 6, 2005 |
Last Updated: | August 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00250289 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
malodor halitosis herbal formulation natural medicinals slow release delivery system |
Signs and Symptoms Signs and Symptoms, Digestive Halitosis |