Day Long Prevention of Oral Malodor With a Palatal Patch (SmellX) Containing A Herbal Formula
- Conditions
- HalitosisGingivitis
- Interventions
- Dietary Supplement: herbal formula for fresh breath
- Registration Number
- NCT01388023
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- random gender
- age
- healthy people
- used antibiotics in the last three months
- suffer from systemic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description smellx herbal formula for fresh breath test group- SmellX palatal patch with the herbal formula smellx palatal patch herbal formula for fresh breath negative control group- SmellX palatal patch with out the herbal formula listerine herbal formula for fresh breath listerine mouth wash chlorhexidine herbal formula for fresh breath poositive control group-mouth wash with chlorhexidine 0.125%
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hadassah Medical Organization,
🇮🇱Jerusalem, Israel