Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250289
Status:
COMPLETED
Last Update Posted:
2010-01-06
First Post:
2005-11-06
Brief Title:
Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the use of a herbal formulation containing sage echinacealavender 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 severityThe 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 eg tongue dorsum interdental space periodontal pockets tonsils and breakdown salivary and oral proteins into their amino acid building blocks Some of these amino acids eg 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 speechin our study we intend to use an aprooved mucosal sticker containing carbopol and hydroxypropylcellulose mixed with the herbal ingredients and placed on the palatal mucosathan 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None