Day Long Prevention of Oral Malodor With a Palatal Patch (SmellX) Containing A Herbal Formula
Condition: Halitosis; Gingivitis
MeSH terms: Gingivitis; Halitosis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): herbal formula for fresh breath
Intervention type(s): Dietary Supplement
Intervention description(s): composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria
Other intervention name(s): chlorhexidine; listerine; diclosan
Intervention MeSH terms: Chlorhexidine; Listerine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SmellX; malodor; halitosis; herbal formulation; natural medicinals; slow release delivery system; gingivitis; Bad Breath