Day Long Prevention of Oral Malodor With a Palatal Patch (SmellX) Containing A Herbal Formula

Phase 2 Clinical Study of a Day Long Effect of SmellX Palatal Patch Containing A Herbal Formula on Malodor

Sponsors

Lead Sponsor: Hadassah Medical Organization

Source Hadassah Medical Organization
Brief Summary

In a previous study the prevention of halitosis by the herbal formula and delivery system (SmellX), were established both in vitro and clinicaly. The duration of relief was established as long as 8 hours. In this study the investigators intend examine the day long efficacy of SmellX.

Detailed Description

Oral malodor is a common complaint among dental patients. This condition derives in most cases form the putrefactive activities of oral microorganisms, primarily anaerobic Gram negative bacteria. These bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, faulty and leaky restorations and tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. Some of these amino acids (e.g. methionine and cysteine) are further metabolized yielding malodorous volatile sulfide compounds (VSC) such as methylmercaptan and hydrogen sulfide.The tongue dorsum and especially its posterior portion are considered the key location for this process. Therefore, the treatment regiment includes in most cases a daily use of tongue scrapers and mouthwashes. Indeed, a recent Cochrane systematic review found tongue scrapers to have short-term efficacy in controlling halitosis.

However, the use of tongue scrapers is unpleasant and induces in many cases a strong gag reflex, and apparently has very little effect on bacterial load of the tongue.

Furthermore, some mouthwashes have been shown to cause adverse side effects such as tooth staining. In a previous study we performed a set of related experiments on a new sustained release delivery system in the form of an adhesive tablet containing an herbal formulation. The adhesive tablet is applied to the palate. This places it right above, and in direct contact with the tongue dorsum, thus allowing a sustained release of the active ingredients directly to the target site. The ingredients of the herbal formulation have been previously shown to reduce malodor production in a salivary incubation assay. We tested the effect of this system on oral malodor production and VSC levels in a young healthy population, and the antimicrobial effect of its active ingredients on three known oral pathogens (Streptoccocus mutans, Porphyromonas gingivalis and Candida albicans. In this study we intend to examine a day long protocol to achieve a relief from oral halitosis for 24 houres.

Overall Status Completed
Start Date January 2008
Completion Date November 2012
Primary Completion Date November 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
reduction of VSC measurements with halimeter 24 hr
Secondary Outcome
Measure Time Frame
reduction of halitosis as measured by judge score 24 hr
Enrollment 60
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: herbal formula for fresh breath

Description: composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria

Eligibility

Criteria:

Inclusion Criteria:

- random gender

- age

- healthy people

Exclusion Criteria:

- used antibiotics in the last three months

- suffer from systemic disease

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michael M Perez Davidi, DMD Principal Investigator Hadassah Medical Centers The hebrew university Jerusalem
Location
Facility: Hadassah Medical Organization,
Location Countries

Israel

Verification Date

November 2012

Responsible Party

Name Title: Hadas Lamberg Dr.

Organization: Hadassah Medical Centers

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: smellx

Type: Active Comparator

Description: test group- SmellX palatal patch with the herbal formula

Label: smellx palatal patch

Type: Placebo Comparator

Description: negative control group- SmellX palatal patch with out the herbal formula

Label: chlorhexidine

Type: Active Comparator

Description: poositive control group-mouth wash with chlorhexidine 0.125%

Label: listerine

Type: Active Comparator

Description: listerine mouth wash

Acronym SmellX
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov