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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01388023
First received: January 17, 2008
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Halitosis
Gingivitis
Dietary Supplement: herbal formula for fresh breath
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Study of a Day Long Effect of SmellX Palatal Patch Containing A Herbal Formula on Malodor

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • reduction of VSC measurements with halimeter [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
    volatile solfur compounds can be measured with a halimeter as an indication of halitosis. decrease of vsc value from base line indicates success in reducing halitosis


Secondary Outcome Measures:
  • reduction of halitosis as measured by judge score [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
    judge score of halitosis on a scale of 1-5 is the gold standart for halitosis measurments. levels lower than base line indicate success in the treatment of halitosis


Enrollment: 60
Study Start Date: January 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: smellx
test group- SmellX palatal patch with the herbal formula
Dietary Supplement: herbal formula for fresh breath
composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria
Other Names:
  • chlorhexidine
  • listerine
  • diclosan
Placebo Comparator: smellx palatal patch
negative control group- SmellX palatal patch with out the herbal formula
Dietary Supplement: herbal formula for fresh breath
composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria
Other Names:
  • chlorhexidine
  • listerine
  • diclosan
Active Comparator: chlorhexidine
poositive control group-mouth wash with chlorhexidine 0.125%
Dietary Supplement: herbal formula for fresh breath
composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria
Other Names:
  • chlorhexidine
  • listerine
  • diclosan
Active Comparator: listerine
listerine mouth wash
Dietary Supplement: herbal formula for fresh breath
composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria
Other Names:
  • chlorhexidine
  • listerine
  • diclosan

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • random gender
  • age
  • healthy people

Exclusion Criteria:

  • used antibiotics in the last three months
  • suffer from systemic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388023

Locations
Israel
Hadassah Medical Organization,
Jerusalem, Israel, 49453
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael M Perez Davidi, DMD Hadassah Medical Centers The hebrew university Jerusalem
  More Information

Additional Information:
Publications:
Responsible Party: Hadas Lamberg Dr., Hadassah Medical Centers
ClinicalTrials.gov Identifier: NCT01388023     History of Changes
Other Study ID Numbers: 1910552HMO-CTIL
Study First Received: January 17, 2008
Last Updated: November 19, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
SmellX
malodor
halitosis
herbal formulation
natural medicinals
slow release delivery system
gingivitis
smellx
Bad Breath

Additional relevant MeSH terms:
Gingivitis
Halitosis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Chlorhexidine
Chlorhexidine gluconate
Listerine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on October 16, 2014