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

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.

• herbal formula for fresh breath (Dietary supplement), also known as chlorhexidine, listerine, diclosan: composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria

Primary outcomes

• reduction of VSC measurements with halimeter [24 hr]: 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 outcomes

• reduction of halitosis as measured by judge score [24 hr]: 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

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

* random gender
* age
* healthy people

Exclusion Criteria:

* used antibiotics in the last three months
* suffer from systemic disease

• Perez Davidi M, Beyth N, Sterer N, Feuerstein O, Weiss EI. Effect of liquid-polish coating on in vivo biofilm accumulation on provisional restorations: part 1. Quintessence Int. 2007 Jul-Aug;38(7):591-6. PMID 17694216
• Results publication: 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. PMID 15459950
• Results publication: Sterer N, Rubinstein Y. Effect of various natural medicinals on salivary protein putrefaction and malodor production. Quintessence Int. 2006 Sep;37(8):653-8. PMID 16922026
• Results publication: Sterer N. Antimicrobial effect of mastic gum methanolic extract against Porphyromonas gingivalis. J Med Food. 2006 Summer;9(2):290-2. doi: 10.1089/jmf.2006.9.290. PMID 16822220

• Michael M Perez Davidi, DMD, Principal investigator, Hadassah Medical Centers The hebrew university Jerusalem