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Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula

Primary Purpose

Halitosis, Oral Malodor, Bad Breath

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
a mucosal sticker with herbal formula
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis focused on measuring malodor, halitosis, herbal formulation, natural medicinals, slow release delivery system

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: random gender, age and healthy people Exclusion Criteria: used antibiotics in the last three months or suffer from systemic disease

Sites / Locations

  • Hadassah Medical Organization,

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2005
Last Updated
January 5, 2010
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00250289
Brief Title
Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula
Official Title
Invivo Study of the Efficacy of an Innovative Herbal Formula and Delivery System on Oral Malodor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis, Oral Malodor, Bad Breath
Keywords
malodor, halitosis, herbal formulation, natural medicinals, slow release delivery system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
a mucosal sticker with herbal formula
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: random gender, age and healthy people Exclusion Criteria: used antibiotics in the last three months or suffer from systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Perez Davidi, DMD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization,
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15459950
Citation
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. doi: 10.1002/jps.20193.
Results Reference
result
Links:
URL
http://www.mypd.co.il
Description
Michael Perez Davidi

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Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula

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